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Transcription:

8ppm 2 2.7

a/a Arterial-alveolar oxygen ratio a/a PaO 2 P A O 2 A-aDO 2 Alveolar arterial oxygen tension difference gradient A-aDO 2 P A O 2 PaO 2 ACT Activated clotting time aptt Activated partial thromboplastin time cgmp cyclic Guanosine monophosphate CINRGI Clinical Inhaled Nitric Oxide Research Group Investigation ECG Electrocardiogram ECMO Extracorporeal membrane oxygenation FiO 2 Fraction of inspired oxygen concentration HbO 2 Oxygenated hemoglobin HFOV High frequency oscillatory ventilation HFV High frequency ventilation MAS Meconium aspiration syndrome MAP Mean arterial pressure MetHb Methemoglobin NINOS Neonatal Inhaled Nitric Oxide Study N 2 Nitrogen NO Nitric oxide NO 2 Nitrogen dioxide NOHb Nitrosyl-hemoglobin OI Oxygenation index cmh 2 O/mmHg OI FiO 2 PaO 2 PaCO 2 Partial pressure of carbon dioxide in arterial blood mmhg PaO 2 Partial pressure of oxygen in arterial blood mmhg P A O 2 Partial pressure of oxygen in the alveolar space mmhg P A O 2 FiO 2 PaCO 2.8 PAP Pulmonary arterial pressure Postductal O 2 sat/tcppo 2 % O 2 saturation post-patent ductus arteriosus in % PPHN Persistent pulmonary hypertension of the newborn Preductal O 2 sat/tcppo 2 % O 2 saturation pre-patent ductus arteriosus in % PEEP Positive end expiratory pressure cmh 2 O PT Prothrombin time RDS Respiratory distress syndrome SaO 2 Arterial oxygen saturation SD Standard Deviation SE Standard Error sgc soluble Guanylate cyclase SpO 2 Oxygen saturation by pulse oximetry

2.7... 2.7.... 2.7..... 2.7..2...2 2.7..3...2 2.7..4...2 2.7.2... 2 2.7.2....2 2.7.2.2...5 2.7.2.3...9 2.7.2.4...2 2.7.2.5...2 2.7.3... 23 2.7.3....23 2.7.3.2...29 2.7.3.3...44 2.7.3.4...59 2.7.3.5...63 2.7.3.6...63 2.7.4... 69 2.7.4....69 2.7.4.2...74 2.7.4.3...29 2.7.4.4...45 2.7.4.5...48 2.7.4.6...53 2.7.4.7...54 2.7.5... 68 2.7.6... 69 2.7.6....69 2.7.6.2 PD...94 2.7.6.3...27

2.7 2.7 2.7. 2.7.. NO 992 PPHN Roberts Lancet ) NO 2.7..- 5 NO 8% 2.7..-2 2) NO 2.7..- NO CTN:NO- 6 5.3.3.-, ppm ICR 3224 5.3.3.-2 95 ppm RDR-76-DD 5.3.3.-3 3) MetHb 2, ppm NO CTN-NO- -8 5.3.3.-4 ICR 342 5.3.4.-,9 ppm CTN:NO- -3 5.3.4.2-, ppm Ohmeda NO-3 5.3.5.2-2 ppm 4 ppm 8 ppm,6 ppm CINRGI 5.3.5.- INO Therapeutics, Inc. 8 ppm INO-/2 5.3.5.-2 ppm 4 ppm,6 ppm INOT2 5.3.5.2- INO Therapeutics, L.L.C. 8 ppm NINOS 5.3.5.4-8 ppm INOSG 5.3.5.4-2 8, ppm NO 5.3.5.4-3 - -

2.7..-2 5 NO NO ppm % 88 5 92 93 89.5 9.33 85 2.7 2.7..2 2.7..3 2.7..4 2.7.2 2.7.2. NO sgccgmp cgmp cgmp NOHb MetHbNO NO NO NO MetHb NO MetHb OI NO OI CTN:NO- -3 5.3.4.2- NO cgmp 4) ICR 342 5.3.4.- in vivo CTN:NO- -633/4-52 5.3.4.-2-2 -

2.7 2.7.2... NO MetHb NO 2.7.2.- 2.7.2.- CTN:NO- -6 CTN-NO- -8 ICR 3224 INO-/2 INOT2 RDR-76-DD a NO 4 ppm 2 NO 4 ppm 2 NO cgmp NO 5 NO 2 8 ppm 5 NO 5 NO NO PPHN NO PPHN INO 346-44 INO-/2 CINRGI NINOS AW-ME NO MetHb GCP/ GCP GCP GCP GCP PPHN GCP GCP GCP a 3) MetHb () NO MetHb CTN:NO- -6 5.3.3.- CTN-NO- -8 5.3.3.-4 3) MetHb RDR-76-DD 5.3.3.-3 CTN-NO- -8 RDR-76-DD CTN:NO- -6 2 7 5 NO 4 ppm 2 MetHb MetHb - 3 -

2.7 ICR 3224 5.3.3.-2 2 5 N NO 2 ppm 8 ppm ) 5 N- cgmp CTN-NO- -8 NO 8 4 4 NO 25 ppm 6 MetHb NOHb in vivo NO 8 6 2 2 4 8 ppm NO NO 5 2 µmol/l in vitro 8 2 6 NO RDR-76-DD 3) MetHb NO MetHb (2) MetHb NO 5 2 8 ppm 4 INO-/2 5.3.5.-2 MetHb MetHb NO 2 ppm INOT2 5.3.5.2- MetHb MetHb 2.7.2..2 NO PPHN 3 3 6 ppm NO NO OI CTN:NO- -3 NO 2.7.3 2.7.2..3 NO 8 5 2 4 ICR 342 ) 2 ppm 8 ppm 8 ppm 72 ppm - 4 -

2.7 2.7.2..4 in vivo NO NO in vivo in vivo NO 4 ppm 2 CTN:NO- -6 2.7.2.2 2.7.2.2. 2.7.2.2.. MetHb CTN:NO- -6 5.3.3.- 2 7 5 23 47 NO/N 2 3% NO 4 ppm 2 5 5 MetHb NO MetHb NO.63.6%.3.2%p. >5% 2.7.2.2- MetHb (%) 2 Vol. Vol. 2 Vol. 3 Vol. 4 Vol. 5 Vol. 6 Vol. 7 Vol. 8 Vol. 9 Vol. Vol. Vol.2-25 25 5 75 25 NO 2.7.2.2- MetHb - 5 -

2.7 2.7.2.2..2 cgmp ICR 3224 5.3.3.-2 2 2 36 2 8 ppm 2) 5 NO 5 N- 5 N- T max.42 5 N- 5 N-2 8 ppm 5 N- C max SD 7.285.624 3.883 2.86 µmol/l AUC - SD 2 8 ppm 54.77 8.423 24.78 72.544 µmol hr/l 5 N- T max T /2 CL/F Vd/F 5 N- 23.28 76.65% 2.7.2.2-5 N- 2 ppm 8 ppm 6 6 T max SD.42.2.42.2..25..25 C max µmol/l SD 7.285.624 3.883 2.86 5.55 9.36 7.5 48.7 SD 6.728.595 6.87.958 T /2 5.49 9.83 5.45 8.9 SD 2.922.22 2.8435.32 CL/FL/hr.59 4.858.63 5.34 SD 26.63 6.856 27.2 9.865 Vd/FL 2.64 38.5 6.63 4.8 ±SD 54.77 8.423 24.78 72.544 AUC - µmol hr/l 35.39 76.58 26.25 329.55 2.7.2.2-2 5 N 72 2 ppm 8 ppm 6 6 µmol SD 75.33 3.834 288.33 58.59 32.98 6.5 25.7 374.72 % SD 55.37 22.47 47.79.78 23.28 76.65 32.6 6.9 cgmp 2 ppm 8 ppm cgmp 2.7.2.2-3 cgmp GLP 2) 2 ppm 8 ppm 8 ppm 72 ppm - 6 -

2.7 2.7.2.2-2 5 N- - 7 -

2.7 2 ppm 2.7.2.2-3 cgmp 8 ppm - 8 -

2.7 2.7.2.2-2-2 NO cgmp -5-3 5 6 2 2 ppm 3.36.68 2.52 4.89 3.27 n=6 SD.57.65.24 3.39 2.22 pmol/ml Plasma Min.44.24.55.6.3 Max 4.89 2.98 4.64.54 7.6 8 ppm 8.7 6.3.93.7 6.49 n=6 SD 3.35.33 8.42 5.8 3.8 pmol/ml Plasma Min 4.39 4.96 4.87 3.38 3.23 Max 2.92 8.8 26.85 6.88.89 2.7.2.2..3 NO MetHb RDR-76-DD 5.3.3.-3 MetHb 3) 5 32 64 28 52 ppm NO 3 52 ppm NO MetHb 5% 5 3 5 8 MetHb 3 5 8 MetHb CTD 5.4.2.3 Young JD, Dyar O, Xiong L, Howell S. Methaemoglobin production in normal adults inhaling low concentrations of nitric oxide. Intensive Care Med. 994; 2(8): 58-584. 3 5 2 5 MetHb 2.7.2.2-3.26 min - 6 52 ppm NO MetHb 2. min - 65 32 52 ppm MetHb Css MetHb 2.7.2.2-4 NO MetHb 4 5 3) MetHb - 9 -

2.7 C K f C NO e -Ke t C base C MetHb %MetHb C NO NOppm K MetHb K e MetHb C base MetHb%MetHb 2 C K f C NO e -Ke T e -Ke(t-T) C base C MetHb %MetHb C NO NOppm K MetHb K e MetHb T NO C base MetHb%MetHb 2.7.2.2-3 NOMetHb Ke T /2 C base K f min - min %MetHb.26 6.64.2 2.7.2.2-4 NOMetHbMetHb NO Css MetHb ppm %MetHb %/min 32.3.48 64 2.7.82 28 3.83.387 52 2.2.424 2.7.2.2..4 NO NO CTN-NO- -8 5.3.3.-4 8 4 4 8 6 2 NO NO 25 ppm 6 NO NO 2 4 8 ppm NO 2 MetHb NOHb 8 5 2 µmol/l 2 5 in vitro % 8 5 92 99% 27 85%MetHb NOHb 8 2 6 - -

2.7 NO NO 25 ppm 6 26 µmol/l 38 µmol/l P. MetHb.35%.64%P. NOHb 2 4 8 ppm NO 72 µmol/l 9 µmol/l 8 ppm P. MetHb.99% 2.9% 8 ppm P. NOHb in vitro 92 99% 2 5 MetHb NOHb 27 85% NOHb NOHb NO 9 4 ml/min NO NOHb NOHb NO 2.7.2.2..5 MetHb INO-/2 5.3.5.-2 PPHN 55 NO NO 5 2 8 ppm 4 48 MetHb MetHb 2 7% N 4 NO 5 ppm N 4 NO 2 ppm N 36 NO 8 ppm N 37 MetHb 2.7.2.2-4 2.7.2.2-5 NO MetHb 8 ppm MetHb 8 2 5% 2 ppm MetHb % - -

2.7 2.7.2.2-4 MetHb SE -INO-/2-8 ppm 2 ppm 5 ppm 2.7.2.2-5 MetHb SD -INO-/2 - NO 2 3 4 8 2 6 2 24 28 32 36 4 44 48 N 36 a 35 36 35 34 33 24 23 2 9 8 7 6 6 4 2.38.79 2.79 3.43 4.22 5.4 5.8 4.33 4.22 4.7 4.9 3.46 3.24 3.22 3.29 3.23 SD.28.94.32.88 2.46 2.75 2.32.65.54.53.65.56.8.99.9 2.2...5....9.2.7.5.5..4.5.9.. 3.8 5.7 7.8.8.9.4 7.3 6.8 6.7 7.3 6.6 6.9 7.2 6.7 7.6 N 36 35 34 33 33 3 27 26 25 23 22 2 2 8 8 6.5.69.8.88.96.5.89.97.98.94.97.95.95.87.9.89 SD.38.39.43.5.56.65.5.54.53.57.5.5.52.5.44.44.....3......2....3..5.6.8 2.2 2.6 3.5 2. 2.8 2.5 2.3 2.2 2. 2.2 2..9.9 N 4 37 39 39 38 37 33 3 28 26 24 23 24 22 2 2.4.5.52.56.57.64.62.68.64.67.68.73.69.55.56.64 SD.3.53.6.56.54.64.7.75.83.76.83.9..38.32.45................. 3. 3.4 3.2 3. 3.5 4. 4.2 4.4 4. 4.2 4.6 5.6.4.4.7 N 39 b 39 35 33 3 3 27 26 23 22 22 2 9 9 7 8.5.46.4.43.45.38.46.47.47.45.48.45.46.49.46.57 SD.4.39.36.4.39.37.4.36.48.44.38.42.36.4.37.46.................6.6.5.9.9.7.6.7.7.7.6.7.4.6.6.6 a 8 ppm 37 MetHb 36 b 4 MetHb 39 8 ppm 36 3 36% MetHb 7%8 ppm 37 MetHb 36 MetHb 2.7.2.2-5 MetHb.46-2 -

2.7 9.46 MetHb 8 4 2 5 ppm MetHb 7% 2. Methemoglobin Levels (%). 8. 6. 4. 2. Pt 5 Pt 33 Pt 36 Pt 329 Pt 45 Pt 55 Pt 63 Pt 66 Pt 74 Pt 2_44 Pt 2_46 Pt 2_73 Pt 2_73. 2 3 4 5 6 Time (hours) 2.7.2.2-5 8 ppm MetHb -INO-/2-2.7.2.2..6 MetHb INOT2 5.3.5.2- NO 2 ppm 4 4 PaO 2 6 mmhg SpO 2 92% 5 ppm NO FiO 2.4.6 PaO 2 7 mmhg 5 ppm MetHb NO 4 2 24 48 72 96 2 44 68 92 MetHb 5% NO MetHb 2.7.2.2..6-2.7.2.2..6- MetHb 2% 2 ppm NO MetHb 5% - 3 -

- 4-2.7.2.2..6- MetHb % Pt No. 4 2 24 48 72 96 2 44 68 92 /.5.8.9.7.5.4 - - - - - -.4 2.4.4.4.4.6 2....6...6.2 22..3.3.6.8 - - - - - - -.2 3.2.6.7.8.7.7.6 - - - - -. 32.3.5.6.7.3 - - - - - - -.3 4.6.3.8 - - - - - - - - -.5 53 n.d..8.7.7.5 - - - - - - -.5 54.7.5.6.3.3.5.8.4.4.4 - -.3 6.3.3.4.3.3..2. - - - -. 7.2.8.7.7.5 - - - - - - -.5 8..4.8.2. - - - - - - -.2 Mean.7.8.9.8.8.9.7.5..7..6.5 SD.5.5.4.5.6.8.4.5.8.4 - -.4 Min..3.4.2...2..4.4..6. Max.5.8.9.7.8 2....6...6.4 n.d. not done 2.7

MetHb (%) 2.5 2.5.5 # # 2 # 22 # 3 # 32 # 4 # 53 # 54 # 6 # 7 # 8 hr 4 hr 2 hr 24 hr 48 hr 72 hr 96 hr 2 hr Hours Post Dose 44 hr 68 hr 92 hr cmpl/discn 2.7.2.2..6- MetHb % 2.7.2.2.2 2.7.2.2.2. PPHN NO OI CTN:NO- -3 5.3.4.2- PPHN NO OI 5 4 cmh 2 O/mmHg 42 26 6 3 3 6 ppm NO 5 SpO 2 85 NO OI NO ppm ppm OI 3. 3. cmh 2 O/mmHg 9.6 2. cmh 2 O/mmHg SE 29. 3.8 cmh 2 O/mmHg 2.9 8.6 cmh 2 O/mmHgSE 2.7.2.2-6 2.7.2.2-7 - 5 -

2.7.2.2-6 OI 5 4 cmh 2 O/mmHg PPHN NO OI SE 2.7.2.2-7 OI 5 4 cmh 2 O/mmHg NO OI SE - 6 -

NO PPHN 79% 5% 25% OI OI 25% 5 3 2 OI 3 ppm 3 ppm NO 2.7.2.2.2.2 ICR 342 5.3.4.- 2 3 NO 3 4 2 7 4 2 NO 6 mg 3 mg 2, IU/mL 5 ml.9% 5 ml 6 mg 3 mg 2 5 NO 8 ppm 3 4 hpp pnp NO hnp NO ppa 4 ACT aptt PT 2.7.2.2-8 2.7.2.2- ACT aptt PT NO NO - 7 -

2.7.2.2-8 2.7.2.2-9 - 8 -

2.7.2.2-8 ppm 3 NO MetHb 2.7.2.2.2.3 CTN:NO- -6 33/4-52 5.3.4.-2 5 5 23 47 NO/N 2 3% 2 4 ppm 2 37 48,5 9 397,469,54 4,52 2,45 8,472 3 NO / NO 2.7.2.3 NO NO NO MetHb NO MetHb - 9 -

PPHN MetHb NO 2 ppm NO MetHb 52 ppm MetHb 5%28 ppm 5% RDR-76-DDPPHN 8 ppm 36 3 36% MetHb 7%INO-/2 MetHb MetHb 4 5 RDR-76-DD MetHb 7%.46 9.46 INO-/2 MetHb 5) MetHb 2 8 ppm 5 NO 5 N- ICR 3224 5 N- 2 8 ppm T max T max 2 8 ppm.42 NO 8 ppm NO NO CTN-NO- -8 NO HbO 2 NO NO Westfelt 6) NO NO 7% NO PPHN 79% 5% 25% OI 25% OI CTN:NO- -3 OI ppm NO OI CINRGI INO-/2 NINOS INOT2 NO NO OI 8 ppm ICR 342 NO NO - 2 -

ICR 342 MetHb NO NO CTN:NO- -6 NO 2.7.2.4 NO 2.7.2.5 2.7.2.5- - 2 -

- 22 - CTN:NO- -3 CTN:NO- -6 CTN-NO- -8 ICR 3224 ICR 342 RDR-76-DD* PPHN NO NO MetHb NO 2 NO 4 ppm 2 NO 4 ppm 2 NO cgmp NO 5 NO 2 8 ppm 5 NO 5 NO NO 2.7.2.5- / 4 4 / 4 4 7 5 / 7 * 5 *: 5 4 4 / 4 4 6 2 / 6 2 8 /8 2 6 / 2 6 2 / 2 2 / 72 72 6 3 23 47 39 5 43 2 23 63 2 33 2 36 33.6.9 8 5 MetHb MetHb 3 2 2.5%5% 3 6 ppm NO 5 NO 2 SD.46.39 ppm 6 3 3 ppm NO 4 ppm 2 NO 25 ppm 6 NO 2, 4, 8 ppm NO 2 ppm NO 8 ppm NO 8 ppm 3 MetHb % 5 ±SD.63.6 5 ±SD.3.2 95%+.5.26,.74 P. MetHb %.35.64 P. 8 ppm MetHb %.99 2.9 MetHb 2 8 µmol/l 5 µmol/l 2 45 µmol/l 5 9 µmol/l SE22 6 ml/min 6 6 ml/min 5 N- C max (µmol/l) 7.285±.624 3.883± 2.86 T max ( ).42±.2.42±.2 AUC - (µmol hr/l) 54.77± 8.423 24.78± 72.544 T /2 () 6.728±.595 6.87±.958 CL/F (L/hr) 2.922±.22 2.8435±.32 NO NO MetHb 4 / NO 32, 64, 28, 52 Ke C base (min - K ) () (%MetHb) f 4 ppm 3 36 3.26 6.64.2 * 3) MetHb T /2 5.3.4.2-5.3.3.- 5.3.4.-2 5.3.3.-4 5.3.3.-2 5.3.4.- 5.3.3.-3 2.7

2.7 2.7.3 2.7.3. 22 2.3-2 2.7.3.- CINRGI INO-/2 INOT2 Ohmeda NO-3 NINOS INOSG 2.7.3.- PPHN PPHN PPHN PPHN PPHN ECMO OI PPHN ECMO OI OI PPHN ECMO OI ECMO OI OI ECMO OI GCP/ GCP GCP GCP GCP GCP GCP GCP GCP CINRGI 5.3.5.- INO-/2 5.3.5.-2 ECMO - 23 -

2.7 ECMO NO ECMO INOT2 5.3.5.2- ECMO ECMO INOT2 ECMO 3 24 OI OI OI PaO 2 OI ECMO OI 4 cmh 2 O/mmHgOI 24 2 cmh 2 O/mmHg OI OI OI a/a PaO 2 /FiO 2 3 24 OI NINOS 5.3.5.4- INOSG 5.3.5.4-2 GCP Ohmeda NO-3 GCP 5.3.5.2-2 5.3.5.4-3 2.7.3.. CINRGI 5.3.5.- PPHN 96 N 2 () NO 2 ppm 4 24 PaO 2 6 mmhg ph 7.35 7.55 5 ppm FiO 2.7 96 7 PaO 2 6 mmhg FiO 2.8 NO - 24 -

2.7 NO FiO 2. PaO 2 6 mmhg MetHb 4% NO 2 5 ppm NO Kinsella JP 7) 2 ppm 4 5 ppm (2) 2.7.3.-2 2.7.3.-2 CINRGI CINRGI ECMO a/a P A O 2 A-aDO 2 PaO 2 OI ECMO ECMO ECMO ECMO 2.7.3..2 INO-/2 5.3.5.-2 PPHN 72 N 2 NO PPHN ECMO NO () 5 2 8 ppm NO ) 4) 4 2% 3 4 ) FiO 2.6 cmh 2 O PaO 2 6 mmhg 2) NO 3 PaO 2 4 mmhg 35 mmhg ECMO 3) NO 2 3 ppm 3 4) 3 2 MetHb 7% - 25 -

2.7 8 ppm NO 3 24 PPHN,7,8) 8 ppm 2 ppm 5 ppm (2) 2.7.3.-3 2.7.3.-3 INO-/2 INO-/2. PPHN ECMO 28 MRI CAT Computer axial tomography 2. ECMO 3. PPHN 4. ECMO 5. 6. 7. MAP ph PaO 2 PaCO 2 SpO 2 OI A-aDO 2 PEEP FiO 2 ECMO 2.7.3..3 INOT2 5.3.5.2- () ) 2 ppm 4 PaO 2 6 mmhg SpO 2 92% 5 ppm 2) FiO 2 NO FiO 2.4.6 PaO 2 7 mmhg 5 ppm 3) FiO 2. (2) 2.7.3.-4-26 -

2.7 2.7.3.-4 INOT2 INOT2. 3 24 OI. 3 24 a/a 2. 3 24 PaO 2 /FiO 2 3 24 OI 3 24 a/a 3 24 PaO 2 /FiO 2 OI ECMO OI 4 cmh 2 O/mmHg OI 24 2 cmh 2 O/mmHg OI NO 3 24 OI OI HFV a/a PaO 2 /FiO 2 2.7.3..4 Ohmeda NO-3 5.3.5.2-2 INO-/2 5 2 8 ppm NO 4 5 2 8 ppm NO 3 4 () 5 2 8 ppm NO ) 4) 4 2% ) FiO 2.6 cmh 2 O PaO 2 6 mmhg 2) NO 3 PaO 2 4 mmhg35 mmhg 3) NO 2 3 ppm 3 4) 3 2 MetHb 7% (2) - 27 -

2.7 2.7.3.-5 2.7.3.-5 Ohmeda NO-3 Ohmeda NO-3. ECMO 2. PPHN ECMO 28 MAP ph PaO 2 PaCO 2 SpO 2 OI A-aDO 2 2.7.3..5 NINOS 5.3.5.4- INOSG 5.3.5.4-2 NINOS PPHN RDSMAS INOSG PPHN NINOS O 2 INOSG N 2 NO () 2.7.3.-6 2.7.3.-6 NINOS INOSG NINOS 2 ppm NO 3 PaO 2 2 mmhg 8 ppm PaO 2 5 mmhg OI cmh 2 O/mmHg NO 2 NO 8 ppm PaO 2 mmhg MetHb % NO 2 7 ppm 336 4 INOSG NO FiO 2.9 8 ppm 2 OI 4 cmh 2 O/mmHg 4 mmhg PaO 2 55 mmhg PaO 2 5% PaO 2 55 mmhg 2 ppm - 28 -

2.7 (2) 2.7.3.-7 2.7.3.-7 NINOS INOSG NINOS ECMO PaO 2 OI A-aDO 2 NO 2 ppm 8 ppm INOSG 2 OI 4 cmh 2 O/mmHg PaO 2 55 mmhg 4 mmhg ph PaO 2 PaCO 2 preductal O 2 sat/tcppo 2 postductal O 2 sat/tcppo 2 ECMO 2.7.3..6 NO 5.3.5.4-3 PPHN NO NO NO () PPHN ppm NO 8 ppm (2) 2.7.3.-8 2.7.3.-8 NO NO NO 5 2 24 72 OI 2.7.3.2 2.7.3.2. PPHN CINRGI 5.3.5.- 34 PPHN 22 4 NO 8 NO N 2 NO 2 ppm 4 24 5 ppm 96 7 NO PPHN 26 86 89 NO 97 ECMO - 29 -

2.7 P. 2.7.3.2-2.7.3.2-2.7.3.2-4 /82 3.4%NO 3/92 3.3%P.2328 P.48 2.7.3.2-2 ECMO 2.7.3.2-3 2.7.3.2- ECMO -CINRGI - NO P ECMO ECMO 5/89 57.3% 38/89 42.7% 3/97 3.9% 67/97 69.%. Cochran-Mantel- Haenszel 2.7.3.2- a/a SE-CINRGI - - 3 -

PaO2 in mm Hg a-a DO2 Gradient 2.7 65 6 55 Placebo Inhaled NO 5 45 4 35 2 4 6 8 2 4 6 8 2 22 24 Time in hours 2.7.3.2-2 A-aDO 2 SE-CINRGI - 6 4 2 8 Placebo Inhaled NO 6 4 2 4 6 8 2 4 6 8 2 22 24 Time 2.7.3.2-3 PaO 2 SE-CINRGI - - 3 -

Oxygenation Index in cm H2O/ mm Hg 2.7 5 4 Placebo 3 Inhaled NO 2 2 4 6 8 2 4 6 8 2 22 24 Time in hours 2.7.3.2-4 OI SE-CINRGI - 2.7.3.2-2 -CINRGI - a P NO Fisher 28 5/88 5.7% 3/97 3.%.48 6 5/88 5.7% 4/97 4.%.738 a 2.7.3.2-3 ECMO -CINRGI - ECMO 28 SD NO P 3/5 9/. 86.7% 8.8% Fisher 6/5 4/. 4.% 36.4% χ 2 7.2 4.4 53. 36.6.4 N 9 N 7 t- 2.7.3.2.2 PPHN INO-/2 5.3.5.-2 PPHN 37 NO 5 2 8 ppm NO PPHN N 2-32 -

2.7 32 HFV 55 4 5 ppm 4 2 ppm 36 8 ppm 37 5 2 8 ppm 4 PPHN ECMO PPHN 56% 23/4 NO 5% 52/4 P.5 2.7.3.2-4 NO 2.7.3.2-5 2.7.3.2-8OI NO 24 NO -.6 NO -5. P. 2.7.3.2-5 PaO 2 A-aDO 2 2.7.3.2-9 2.7.3.2-2.7.3.2-4 PPHN -INO-/2 - N 2 NO 5 ppm 2 ppm 8 ppm 28 /4 2% 2/4 5% 4/36 % 3/37 8% 9/3 8% [.54] [.3] [.26] [.22] ECMO 4/4 34% /4 24% 9/36 25% 6/37 6% 25/4 22% [.33] [.38] [.7] [.2] i) 5/34 5% /32 34% 7/3 23% 23/97 24% /39 26% [.25] [.43] [.77] [.8] ii) 9/38 24% 3/3 % 3/34 9% 5/3 5% 5/4 3% [.2] [.7] [.6] [.75] 8/36 5% 2/35 6% 3/33 39% 52/4 5% 23/4 56% [.6] [.73] [.6] [.5] i)mri CT ii) 28 X [ ] P Cochran-Mantel-Haenszel NO - 33 -

2.7 6 4 Pooled NO Placebo PaO2 (mm Hg) 2 8 6 4..5..5 2. 2.5 3. Time (hours) 2.7.3.2-5 PaO 2 SE -INO-/2-6 58 Placebo Pooled NO A-aDO2 mm HG 56 54 52 5 48.5 2 3 Time (hours) 2.7.3.2-6 A-aDO 2 SE -INO-/2 - - 34 -

2.7 2.7.3.2-7 a/a SE -INO-/2-2.7.3.2-8 OI SE -INO-/2 - - 35 -

2.7 2.7.3.2-5 24 OI -INO-/2 - N 2 NO 5 ppm 2 ppm 8 ppm 4 4 36 37 4 cmh 2 O/mmHg -.6-4.67-4.78-5.59-5. SD 7.99 7.69.5 7.4 8.4-2.78, 4.68-25.36, 3.65-36.2, 3.67-23.58, 8.7-36.2, 3.67 P -.5..2. Wilcoxon 2.7.3.2-9 PaO 2 SE -INO-/2 - - 36 -

2.7 2.7.3.2- A-aDO 2 SE -INO-/2-2.7.3.2.3 INOT2 5.3.5.2-34 3 24 OI SD-2.3 37. cmh 2 O/mmHg -9.7 37.9 cmh 2 O/mmHg -27.2 33. cmh 2 O/mmHg 2.7.3.2-6 - 37 -

2.7 2.7.3.2-6 OI cmh 2 O/mmHg INOT2 CINRGI a INO-/2 a NINOS a a 3 4 4 42 35.5 35.8 24.4 45.4 46.8 SD 35.6 24.5.4 33.9 3.2 3-2.3 -.2-4.7-5. SD 37. 6.6 7.6 2.4 NA -9.7 -.2-4.2-2.9 NA SD 37.9 22.3 8.8 28.9 24-27.2-8.4-9.7-28. NA SD 33. 7.4.2 35.2 INOT2 generalized linear model P F.9.26 b.8 NA a CINRGI NINOS NO INO-/2 5 ppm NO 34 INOT2 CINRGI NO 2 NO b NINOS 2 a/a PaO 2 /FiO 2 2.7.3.2-7 2.7.3.2-8 a/a PaO 2 /FiO 2 NO NO 2.7.3.2-7 a/a INOT2 CINRGI a INO-/2 a a 7 4 44.88.3.6.68 SD.5.98.88.46 3 +.246 +.82 +.5 SD.22.33.86 NA +.225 +.93 +.47 +.97 SD.23.47.3.32 24 +.26 +.5 +.92 +.52 SD.76.63..53 INOT2 generalized linear model... P F NA a CINRGI NO INO-/2 5 ppm NO 34 INOT2 CINRGI NO 2 NO - 38 -

2.7 2.7.3.2-8 PaO 2 /FiO 2 INOT2 CINRGI a INO-/2 a a 7 4 44 3 24 INOT2 generalized linear model P F SD SD SD SD 58.3 33.8 +66.5 49.8 +5.3 42.8 +52.9 6. 76. 67.3 +55.9 9.4 +62.7. +96.3 8.6 7.8 6.5 +34.2 59.3 +3.7 7. +62.4 74.8 46.5 3.7 NA +65.8 9. +99.4 98.7..2. NA a CINRGI NO INO-/2 5 ppm NO 34 INOT2 CINRGI NO 2 NO 2.7.3.2.4 PPHN Ohmeda NO-3 5.3.5.2-2 PPHN 72 5 2 8 ppm 4 4 PPHN NO INO-/2 2.7.3.2.5 NINOS NINOS 5.3.5.4-34 235 2 NO 4 NO ECMO % O 2 NO PaO 2 OI A-aDO 2 NO 2 ppm 4 2 ppm 8 ppm 2 8 ppm ECMO P.6 2.7.3.2-9 3 PaO 2 OI A-aDO 2 NO P. 2.7.3.2-2.7.3.2-3 - 39 -

Change in Oxygenation Index (cm H2O/torr) Change in PaO2 (torr) 2.7 ECMO ECMO 2.7.3.2-9 2 ECMO NINOS - 2/2 7% 66/2 55% 77/2 64% NO 6/4 4% 44/4 39% 52/4 46% P χ 2.6.4.6 7 6 5 4 3 2 Placebo Dose Group Inhaled NO 2.7.3.2-3 PaO 2 SE -NINOS - 5.. -5. -. -5. -2. Placebo Inhaled NO Dose Group 2.7.3.2-2 3 OI SE -NINOS - - 4 -

2.7 2.7.3.2-3 3 A-aDO 2 SE -NINOS - 2 ppm PaO 2 mmhg PaO 2 2 mmhg 8 ppm 75 75% NO 55 4 75% 8 ppm 2.7.3.2- - 4 -

2.7 2.7.3.2- NO 2 ppm NO 2 ppm NO 8 ppm NINOS - 2 ppm a NO 2 ppm b N 7 N 2 PaO 2 mmhg 87 74.4% 38 33.9% PaO 2 2 mmhg 3.% 7 5.2% PaO 2 2 mmhg 7 4.5% 57 5.9% 8 ppm NO 8 ppm NO 2 ppm N 87 N 38 PaO 2 mmhg 64 73.6% 29 76.3% PaO 2 2 mmhg 5 5.7% 5 3.2% PaO 2 2 mmhg 2 3.8% 2 5.3% 6 6.9% 2 5.3% NO 8 ppm 8 ppm NO 2 ppm N 3 N 7 PaO 2 mmhg 84.6% 2 7.6% PaO 2 2 mmhg 7.7% 4 23.5% PaO 2 2 mmhg 5.9% 7.7% P χ 2 P. P.3 P.34 a NO 3 PaO 2 b NO 4 NO NO 2.7.3.2.6 INOSG INOSG 5.3.5.4-2 PPHN 58 28 NO 3 PPHN NO 2 ECMO 7% 2/28 NO 53% 6/3 NO Cochran-Mantel-Haenszel χ 2 P. 2.7.3.2-4 2.7.3.2-5 2 PaO 2 OI NO Wilcoxon PaO 2 P. OI P. NO 2 OI 4 cmh 2 O/mmHg PaO 2 55 mmhg 4 mmhg - 42 -

2.7 2.7.3.2-4 2 PaO 2 SE -INOSG - 5. Oxygenation Index (cm H2O/ mm Hg) 45. 4. 35. 3. 25. 2. 5. Control Inhaled NO. Baseline 2 minutes Time Period 2.7.3.2-5 2 OI SE -INOSG - - 43 -

2.7 ECMO 7% 2/28 NO 4% 2/3 NO Cochran-Mantel-Haenszel χ 2 P.2 2.7.3.2-2.7.3.2- ECMO INOSG - NO ECMO 2/28 7% 2/3 4% ECMO 8/28 29% 8/3 6% Cochran-Mantel-Haenszel χ 2 P.2 2.7.3.2.7 NO 5.3.5.4-3 NO 8 995 5 997 5 PPHN NO 68 55 8% NO NO 24 OI 2 cmh 2 O/mmHg 43 NO NO PPHN 2.7.3.3 CINRGI INO-/2 Ohmeda NO-3 NINOS INOSG INOT2 2.7.3.3. 2.7.3.3.. PPHN INOT2 2.7.3.3- INO-/2 INOT2 Ohmeda NO-3 INO-/2 Ohmeda NO-3 NINOS INOSG CINRGI NO ECMO - 44 -

- 45 - CINRGI INO-/2 INOT2 PPHN 34 96 4 OI 25 cmh 2 O/mmHg PPHN 37 37 2,5 g 39 2, g 72 FiO 2. cmh 2 O PaO 2 4 mmhg SpO 2 % PPHN 2.7.3.3-34 NO 68 FiO 2. PaO 2 8 mmhg i) ii) SpO 2 Ohmeda NO-3 PPHN 37 37 2,5 g 39 2, g 72 FiO 2. cmh 2 O PaO 2 4 mmhg SpO 2 % PPHN NINOS PPHN RDS MAS 34 4 OI 25 cmh 2 O/mmHg 24 INOSG PPHN 37 2,5 g FiO 2. 3 2 PaO 2 55 mmhg PPHN 7 3 PaO 2 8 mmhg HFOV 2.7

- 46 - CINRGI INO-/2 INOT2 ECMO ECMO 35 mmhg 7% HFOV 2.7.3.3-6 OI 4 cmh 2 O/mmHg 35 mmhg 8 bpm 6 bpm Ohmeda NO-3 35 mmhg 7% HFOV NINOS INOSG 37 2,5 g 4 mmhg 24 7% ECMO HFV 2.7

2.7 2.7.3.3..2 2.7.3.3-2 INO-/2 Ohmeda NO-3 PaO 2 4 7 mmhg OI 2 45 cmh 2 O/mmHg CINRGI - 47 -

- 48 - CINRGI NO 2.7.3.3-2 INO-/2 NO 5 ppm 2 ppm 8 ppm INOT2 Ohmeda NO-3 NO 5 ppm 2 ppm 8 ppm NINOS NO INOSG 2 a a 4 4 36 37 4 8 2 2 4 28 3 63 52 27 9 2 9 4 4 4 76 63 8 6 39 58 4 22 6 8 6 4 45 5 4 kg, ±SD 3.2±.6 3.3±.5 3.4±.5 3.5±.5 3.4±.6 3.4±.5 3.2±.5 3.9±.8 3.3±.5 3.2±.4, ±SD 38.8±2. 39.±.9 39.7±.8 4.2±.5 39.3±.6 39.9±.5 39.3±.9 39.8±.5 39.6±.9 38.5±2. 3.4±.6 (N=2) 38.9±2.2 (N=2) 3.5±.6 (N=3) 39.3±.8 (N=3) NO 3.6±.6 3.4±.6 4.±.2 39.8±.5 PPHN 24 32 5 5 6 3 2 22 9 28 3 MAS 35 34 26 26 7 7 5 4 58 58 NA NA 2 24 3 9 3 24 26 NA NA RDS 8 8 4 4 7 2 2 5 NA NA 4 2 5 6 8 8 2 2 NA NA ±SD 5.±2.8 5.2±2.6 5 ±SD 7.±2.2 7.2±2. OI cmh 2 O/mmHg, ±SD 5.2±2.7 (N=4) 7.3±2. (N=4) 5.6±2.7 (N=4) 7.8±.7 (N=4) 4.8±2.9 (N=34) 6.3±2.5 (N=35) 5.±3. (N=36) 7.3±2. (N=36) 5.3±2.5 8.±. 4.8±2.8 4.±4.2 7.±.9 9.±. 7.±.9 6.±2.8 5.5±2.7 (N=2) 7.2±2.2 (N=9) 5.2±2.8 (N=3) 7.±2. (N=4) 3.7±2.7 4.4±2.5 5.9±2.6 6.3±2.5 42.±2.6 35.8±24.5 25.3±.4 24.4±.4 25.3±9.5 22.4±7.3 35.5±35.6 22.3±5. 25.8±8. 8.7±4.3 45.±22.4 43.±7.6 45.9±8. 42.±5.4 PaO 2 mmhg, ±SD 53.±33. 75.7±67.4 58.6±5.8 68.2±57.5 6.±5.8 63.7±26.6 58.3±33.8 58.±7.4 53.±8.4 68.±5.6 45.5±3.9 46.8±5.5 38.±9. 4.3±9.4 a NO 2 NO NA 2.7

2.7 2.7.3.3..3.8 NO 34 34.8 CINRGI 26 CINRGI ECMO 2.7.3.3-3 2.7.3.3-3 ECMO -CINRGI - ECMO 28 SD NO P 3/5 9/. 86.7% 8.8% Fisher 6/5 4/. 4.% 36.4% Fisher 7.2 4.4 53. 36.6.4 N 9 N 7 t-.8.8.8.8-49 -

2.7 2.7.3.3..4 2.7.3.3-4 NO ECMO INO-/2 8 ppm 8 ppm 36 3 36%8 ppm 37 MetHb 36-5 -

- 5 - CINRGI NO 2.7.3.3-4 INO-/2 NO 5 ppm 2 ppm 8 ppm INOT2 Ohmeda NO-3 5 ppm 2 ppm 8 ppm NINOS 2 b b 4 4 36 37 4 8 2 2 4 34 62 8 22 9 3 5 2 53 68 a 48 a 23 a 9 a 7 a 27 a 3 2 a 6 a ECMO 56 34 NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA 2 2 2 NA NA NA NA NA NA NA NA NA MetHb 7% NA NA 3 NA NA NO 2 3 ppm 3 NO NA NA NA NA 37 8 NA NA NA NA NA NA NA 7 29 PaO 2 4 mmhg 3 NA NA 4 9 9 8 NA NA 35 mmhg NA NA 2 NA NA 8 7 NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA 4 NA NA NA NA NA NA 8 8 7 5 2 NA NA 6 2 2 25 29 a bno 2 NO NA 2.7

2.7 2.7.3.3.2 2.7.3.3.2. 22 2 () NO 8% 9% 2) NO (2) (3) OI 2.7.3.3.2.2 () ECMO ECMO 2.7.3.3- INO-/2 NO ECMO CINRGI P. INO-/2 P.2 NINOS P.4 INOSG P.2 P. Percent Receiving ECMO 8% 7% 6% 5% 4% 3% 2% % P=. P=.2 P=.4 P=.2 P<. Placebo NO % CINRGI N=86 INO - /2 N=55 NINOS N=235 INOSG N=58 Total N=634 Study 2.7.3.3- ECMO - 52 -

2.7 (2) 2.7.3.3-2 NO NO CINRGI P.48 INO-/2 P.22 NINOS P.6 INOSG P.7 P.59INO-/2 NO INOT2 8% 6% 4% Placebo NO Percent Dead 2% % 8% 6% 4% 2% % CINRGI N=85 INO - /2 N=54 NINOS N=235 INOSG N=58 Total N=632 Study 2.7.3.3-2 (3) OI A-aDO 2 PaO 2 a/a PaO 2 /FiO 2 OI PaO 2 A-aDO 2 a/a PaO 2 /FiO 2 ) OI OI ECMO OI NO CINRGI NINOS INOSG NO CINRGI P.3 NINOS P. INOSG P. 2.7.3.3-3 2.7.3.3-5 - 53 -

Change in Oxygenation Index (cm H2O/torr) Oxygenation Index in cm H2O/ mm Hg 2.7 5 4 Placebo 3 Inhaled NO 2 2 4 6 8 2 4 6 8 2 22 24 Time in hours 2.7.3.3-3 OI SE-CINRGI - 5.. -5. -. -5. -2. Placebo Dose Group Inhaled NO 2.7.3.3-4 3 OI SE -NINOS - - 54 -

PaO2 in mm Hg 2.7 5. Oxygenation Index (cm H2O/ mm Hg) 45. 4. 35. 3. 25. 2. 5. Control Inhaled NO. Baseline 2 minutes Time Period 2.7.3.3-5 2 OI SE -INOSG - 2) PaO 2 PaO 2 NO PaO 2 NO CINRGI P. NINOS P. INOSG P. 2.7.3.3-6 2.7.3.3-8 6 4 2 8 Placebo Inhaled NO 6 4 2 4 6 8 2 4 6 8 2 22 24-55 - Time 2.7.3.3-6 PaO 2 SE-CINRGI -

Change in PaO2 (torr) 2.7 7 6 5 4 3 2 Placebo Dose Group Inhaled NO 2.7.3.3-7 3 PaO 2 SE -NINOS - 2.7.3.3-8 2 PaO 2 SE -INOSG - 3) A-aDO 2 A-aDO 2 A-aDO 2 NO A-aDO 2 CINRGI NINOS NO CINRGI P. NINOS P. 2.7.3.3-9 2.7.3.3- - 56 -

a-a DO2 Gradient 2.7 65 6 55 Placebo Inhaled NO 5 45 4 35 2 4 6 8 2 4 6 8 2 22 24 Time in hours 2.7.3.3-9 A-aDO 2 SE-CINRGI - 2.7.3.3-3 A-aDO 2 SE -NINOS - a/a PaO 2 /FiO 2 NO INOT2 2.7.3.3-5 - 57 -

2.7 2.7.3.3-5 -INOT2-3 24 SD OI a/a PaO 2 /FiO 2 35.5.88 58.3 35.6.5 33.8-2.3 +.246 +66.5 37..22 49.8-9.7 +.225 +5.3 37.9.23 42.8-27.2 +.26 +52.9 33..76 6. NO 2.7.3.3.3 CINRGI 26 CINRGI ECMO NO 2.7.3.3-6 2.7.3.3-6 ECMO -CINRGI - ECMO 28 SD NO P 3/5 9/. 86.7% 8.8% Fisher 6/5 4/. 4.% 36.4% Fisher 7.2 4.4 53. 36.6.4 N 9 N 7 t- 2,5 g 29 NO 2.7.6.3.9Kinsella JP 9) 32 NO 48 NO P.3Schreiber ) NO - 58 -

2.7 2.7.3.4 NO NOHb NO NOHb MetHb NO NO NO MetHb NO MetHb INO-/2 NO MetHb 2.7.3.4-2.7.3.4- NO 2.7.3.4- MetHb SE -INO-/2 - - 59 -

2.7 2.7.3.4- MetHb SD -INO-/2 - NO 2 3 4 8 2 6 2 24 28 32 36 4 44 48 N 36 a 35 36 35 34 33 24 23 2 9 8 7 6 6 4 2.38.79 2.79 3.43 4.22 5.4 5.8 4.33 4.22 4.7 4.9 3.46 3.24 3.22 3.29 3.23 8 ppm SD.28.94.32.88 2.46 2.75 2.32.65.54.53.65.56.8.99.9 2.2...5....9.2.7.5.5..4.5.9.. 3.8 5.7 7.8.8.9.4 7.3 6.8 6.7 7.3 6.6 6.9 7.2 6.7 7.6 N 36 35 34 33 33 3 27 26 25 23 22 2 2 8 8 6.5.69.8.88.96.5.89.97.98.94.97.95.95.87.9.89 2 ppm SD.38.39.43.5.56.65.5.54.53.57.5.5.52.5.44.44.....3......2....3..5.6.8 2.2 2.6 3.5 2. 2.8 2.5 2.3 2.2 2. 2.2 2..9.9 N 4 37 39 39 38 37 33 3 28 26 24 23 24 22 2 2.4.5.52.56.57.64.62.68.64.67.68.73.69.55.56.64 5 ppm SD.3.53.6.56.54.64.7.75.83.76.83.9..38.32.45................. 3. 3.4 3.2 3. 3.5 4. 4.2 4.4 4. 4.2 4.6 5.6.4.4.7 N 39 b 39 35 33 3 3 27 26 23 22 22 2 9 9 7 8.5.46.4.43.45.38.46.47.47.45.48.45.46.49.46.57 SD.4.39.36.4.39.37.4.36.48.44.38.42.36.4.37.46.................6.6.5.9.9.7.6.7.7.7.6.7.4.6.6.6 a 8 ppm 37 MetHb 36 b 4 MetHb 39 INO-/2 5 ppm 8 ppm NO 2.7.3.4-2 2.7.3.4-3 2.7.3.4-2 PaO 2 SE -INO-/2 - - 6 -

2.7 2.7.3.4-3 A-aDO 2 SE -INO-/2 - CINRGI 2 ppm 4 24 PaO 2 6 mmhg ph 7.35 7.55 5 ppm FiO 2.7 96 7 ECMO NO NO INOT2 2 ppm FiO 2. 4 PaO 2 6 mmhg SpO 2 92% 5 ppm OI 2 ppm NINOS 2 ppm 8 ppm 55 4 Cornfield ) 2 ppm NO 2 ppm 2 ppm NO MetHb NO 2 MetHb - 6 -

2.7 NO 2 NO 2 5 ppm MetHb 5) MetHb MetHb CINRGI 4% INO-/2 Ohmeda NO-3 7% INOT2 5%INO-/2 MetHb 7% INO-/2 MetHb 2 ppm MetHb % 8 ppm 5% MetHb 7% MetHb 36 3 36%8 ppm 37 MetHb 36 NO 2 8 ppm 2 ppm NO 2 2 ppm.5 ppm 8 ppm CINRGI INOT2 2 ppm MetHb 2% NO 2.5 ppm ppm 34 45 32 9 2 ppm 2,5 g 2,5 g 34 34 34 45 ppm MetHb NO 2 2 ppm 4 2 ppm MetHb NO 2 4 5 ppm CINRGI 5 ppm FiO 2.7 FiO 2.4 INOT2 CINRGI FiO 2.4.6 PaO 2 7 mmhg 5 ppm CINRGI 5 ppm - 62 -

2.7 CINRGI 96 96 7 INO-/2 72 4 NINOS 4 4 INOT2 7 4 NO 2.7.3.4-2 2.7.3.4-2 NO SD CINRGI 5.3.5.- 93 4. 3.65 INO-/2 5.3.5.-2 5ppm 22.3 64.9 2ppm 9 82.5 47. NINOS 5.3.5.4-3 a 7.3 79. INOT2 5.3.5.2-83.6 2.6 a: NO CINRGI INO-/2 PPHN PPHN 7 7 7 INO-/2 5ppm 4 2.7.3.5 2.7.3.6 2.7.3.6-2.7.3.6-2 - 63 -

- 64 - CINRGI 8 5.3.5.- INO-/2 25 5.3.5.-2 9 9 22 994 4 996 7 55 2.7.3.6- SD NO 52/58 39..9 63/39 38.8 2. 86 5 ppm 9/22 4.2.5 2 ppm 2/6 39.3.6 8 ppm 9/8 39.9.5 27/4 39.7.8 PPHN 34 96 4 OI 25 cmh 2 O/mmHg PPHN 37 37 2,5 g 39 2, g 72 FiO 2. cmh 2 O PaO 2 4 mmhg SpO 2 % PPHN ECMO a/a A-aDO 2 PaO 2 OI PPHN ECMO ECMO MAP PaO 2 PaCO 2 SpO 2 OI A-aDO 2 PEEP FiO 2 / NO 2 ppm 5 ppm 96 7 NO 5 ppm NO 2 ppm NO 8 ppm 4 22/22 5 ppm 4/22 2 ppm 36/9 8 ppm 37/ 4/8 2.7

- 65 - INOT2 5.3.5.2- Ohmeda NO-3 7 5.3.5.2-2 2 2 9 9 4 2.7.3.6- SD 4/6 39.3.9 4/7 39.4.9 5 ppm 4/ 39.8.5 2 ppm 4/4 39.6.9 8 ppm / 38.5 2. 34 NO 68 7 FiO 2. PaO 2 8 mmhg i) ii) SpO 2 PPHN 37 37 2,5 g 39 2, g 72 FiO 2. cmh 2 O PaO 2 4 mmhg SpO 2 % PPHN OI a/a PaO 2 /FiO 2 ECMO PPHN ECMO 28 MAP ph PaO 2 PaCO 2 SpO 2 OI A-aDO 2 / NO 2 ppm 5 ppm 4 NO 5 ppm NO 2 ppm NO 8 ppm 4 / 5 ppm 4/3 2 ppm 8/5 8 ppm 2/ 2.7

- 66 - NINOS 9 5.3.5.4- INOSG 7 5.3.5.4-2 9 9 235 992 7 995 58 2.7.3.6- SD NO PPHN RDS MAS 63/5 39.3.8 34 76/45 4 38.9 2.2 OI 25 cmh 2 O/mmHg 24 NO 6/4 39.8.5 8/ 4..2 PPHN 37 2,5 g FiO 2. 3 2 PaO 2 55 mmhg ECMO PaO 2 OI A-aDO 2 NO 2 ppm 8 ppm 2 OI 4 cmh 2 O/mmHg PaO 2 55 mmhg 4 mmhg ph PaO 2 PaCO 2 preductal O 2 sat/tcppo 2 postductal O 2 sat/tcppo 2 ECMO / NO 2 ppm 8 ppm 4 NO 8 ppm 2 235/73 58/58 2.7

- 67-8 5.3.5.4-3 995 5 997 5 68 2.7.3.6- SD PPHN 7 3 PaO 2 8 mmhg HFOV OI / NO ppm 8 ppm 68/68 2.7

- 68 - CINRGI 8 5.3.5.- 2.7.3.6-2 ECMO 95% P OI PaO 2 A-aDO 2 89 57.3% 5/89-3. -., 43.5 25. -7., 236. -493.8-659.6, 57.7 NO 2 ppm 5 ppm 97 3.9% 3/97 P. a -22. -3.4, 2.6 2. -262., 33. -482.5-643., 25. INO-/2 4 34.% 4/4 -. -2.9, 33.6-2. -4., 34. -3.8-442.7, 62. NO 5 ppm 4 24.4% /4 P.33 a NO 2 ppm 36 25.% 9/36 P.38 a 25-7.6-52.9, 27. 9. -74., 36. -89.9-486.9, 7. 5.3.5.-2 NO 8 ppm 37 6.2% 6/37 P.7 a INOT2 NO 2 ppm 5 ppm NA NA -29.3 SD:47. +57.5 SD:28.2 5.3.5.2- Ohmeda NO-3 NO 5 ppm 4.% /4 7 NO 2 ppm 8 25.% 2/8 NA -2.2-26.2, 7.7 5. -42.,. -28.4-374.2, 38.3 5.3.5.2-2 NO 8 ppm 2 5.% /2 NINOS 9 5.3.5.4- INOSG 7 5.3.5.4-2 8 5.3.5.4-3 2 55% 66/2 NA NA NA P.4 b NO 4 39% 44/4 NA NA NA 2 ppm 28 7.4% 2/28 NA NA NA P.2 a NO 3 4.% 2/3 NA NA NA 8 ppm NO 8% 55/68 NO ppm Early Response 68 NA NA 8 ppm 63% 43/68 Late Response 8% 2/68 a Cochran-Mantek-Haenzel b χ 2 NO OI 2 cmh 2 O/mmHg NA INOT2 ECMO 2.7

2.7 2.7.4 2.7.4. 2.7.4.. CINRGI 5.3.5.- INO-/2 5.3.5.-2 Ohmeda NO-3 5.3.5.2-2 INOT2 5.3.5.2- MetHb NO 2 INO-/2 5.3.5.4-4 NINOS 2 5.3.5.4-5 INOT2 CTN:NO- -6 5.3.3.- CTN-NO- -8 5.3.3.-4 ICR 342 5.3.4.- 2.7.4.- CINRGI 5.3.5.- INO-/2 5.3.5.-2 INO-/2 5.3.5.4-4 INOT2 5.3.5.2- Ohmeda NO-3 5.3.5.2-2 NINOS 5.3.5.4-5 NINOS 2 5.3.5.4-4 INOSG 5.3.5.4-2 2.7.4.- MetHb NO2 ECMO ECMO MetHb NO 2 MetHb NO 2 MetHb NO 2 MetHb NO 2 MetHb - 69 -

2.7 2.7.4..2 2.7.4..2. 2.7.4.-2 CINRGI 96 INOSG 8 ppm 2 PaO 2 55 mmhg 2 NO ppm NO 4 CINRGI INOT2 2 ppm INO-/2 Ohmeda NO-3 NINOS 8 ppm NINOS ppm 2. 42.8 5.6±45.8 335.7 4-7 -

- 7 - CINRGI 2.7.4.-2 NO NO 2 ppm 5 ppm INO-/2 NO 5 ppm 2 ppm 8 ppm INOT2 Ohmeda NO-3 2 ppm NO 5 ppm 5 ppm 2 ppm 8 ppm NINOS 2 a a 4 4 36 37 4 8 2 2 4 b 24 62 44 8 5 3 8 2 9 5 48 9 25 4 5 8 7 4 9 72 8 4 5 3 3 2 8 7 96 7 4 4 2 2 4 5 2 6 6 6 8 2 44 2 3 5 3 68 4 2 4 2 5 4 3 3 2 4 NO 2 ppm/ 8 ppm SD 26.2±3. 42.5±35.3 67.9±73.8 7.±67. 54.7±49. 49.±53.2 83.6±63.9 6.7±48.7 5.6±45.8 58.9±73.3 2.±42.8 67.7±77.8 9. 3. 33.8 5.8 38.7 25.5 54.5 54.3 9. 58.9.8 36.3...2.6.7 2.4 23.7 2.3 6.5 7..3.3 97.7 8.3 283.5 253.3 92.8 68.3 26.6 22. 67.4.7 259.8 335.7 INOSG 8 ppm 2 PaO 2 55 mmhg 2 NO ppm NO ano 2 NO b ppm 2.7

2.7 2.7.4..2.2 2.7.4.-3 2.7.4.-3 NO 2 ppm 25 ppm 4 ppm 8 ppm CTN:NO- 2 2 - - 2 - -6 4-4 - - CTN-NO- 4-4 - - -8 * 8 8-8 8 ICR 342 2 3 - - - 2 * CTN-NO- -8 NO MetHb 2 8 ppm NO 2 2.7.4..3 INOT2 ITT 2.7.4.-4 34 CINRGI INOT2 34 NINOS 37 INO-/2 Ohmeda NO-3 INOSG PaO 2 4 7 mmhg OI 2 45 cmh 2 O/mmHg - 72 -

- 73 - CINRGI NO 2.7.4.-4 INO-/2 NO 5 ppm 2 ppm 8 ppm INOT2 Ohmeda NO-3 NO 5 ppm 2 ppm 8 ppm NINOS NO INOSG 2 a a 4 4 36 37 4 8 2 2 4 28 3 63 52 27 9 2 9 4 4 4 76 63 8 6 39 58 4 22 6 8 7 4 45 5 4 kg, ±SD 3.2±.6 3.3±.5 3.4±.5 3.5±.5 3.4±.6 3.4±.5 3.2±.5 3.9±.8 3.3±.5 3.2±.4, ±SD 38.8±2. 39.±.9 39.7±.8 4.2±.5 39.3±.6 39.9±.5 39.3±.9 39.8±.5 39.6±.9 38.5±2. 3.4±.6 (N 2) 38.9±2.2 (N 2) 3.5±.6 (N 3) 39.3±.8 (N 3) NO 3.6±.6 3.4±.6 4.±.2 39.8±.5 PPHN 24 32 5 5 6 3 2 22 9 28 3 MAS 35 34 26 26 7 7 5 4 58 58 NA NA 2 24 3 9 3 24 26 NA NA RDS 8 8 4 4 7 2 2 5 NA NA 4 2 5 6 8 8 2 2 NA NA ±SD 5.±2.8 5.2±2.6 5 ±SD 7.±2.2 7.2±2. OI cmh 2 O/mmHg, ±SD 5.2±2.7 (N 4) 7.3±2. (N 4) 5.6±2.7 (N 4) 7.8±.7 (N 4) 4.8±2.9 (N 34) 6.3±2.5 (N 35) 5.±3. (N 36) 7.3±2. (N 36) 5.3±2.4 8.±. 4.8±2.8 4.±4.2 6.9±.9 b 9.±. 7.±.9 6.±2.8 5.5±2.7 (N 2) 7.2±2.2 (N 9) 5.2±2.8 (N 3) 7.±2. (N 4) 3.7±2.7 4.4±2.5 5.9±2.6 6.3±2.5 42.±2.6 35.8±24.5 25.3±.4 24.4±.4 25.3±9.5 22.4±7.3 35.5±35.6 22.3±5. 25.8±8. 8.7±4.3 45.±22.4 43.±7.6 45.9±8. 42.±5.4 PaO 2 mmhg, ±SD 53.±33. 75.7±67.4 58.6±5.8 68.2±57.5 6.±5.8 63.7±26.6 58.3±33.8 58.±7.4 53.±8.4 68.±5.6 45.5±3.9 46.8±5.5 38.±9. 4.3±9.4 a CINRGI NO 2 NO b 2 3 NA 2.7

2.7 2.7.4.2 2.7.4.2. () ) 2.7.4.2- NINOS INOSG MetHb CINRGI INO-/2 INOT2 Ohmeda NO-3-74 -

- 75-2.7.4.2- CINRGI INO-/2 INOT2 Ohmeda NO-3 CINRGI INO-/2 INOT2 Ohmeda NO-3 NO 2 ppm NO 5 ppm NO 2 ppm NO 8 ppm NO 2 ppm NO 5 ppm NO 2 ppm NO 8 ppm N 2 a N a N 4 N 4 N 36 N 37 N N 4 N 8 N 2 95 4 2 2 3 22 9 6 6 83 6 92 2 2 4 9 8 9 2 5 % % 2 2% 9% b % 9% b % % % 5 5% 3% 5% % % % % 2 2% % 9% 3 3% 5 5% % 6 5% % 2% 2% 6 6% 8 7% 2 5% 3% % 2% % % % % 3% 5% % 2 2% % 5 5% 6 6% 8 7% 2 5% 2% 3% 3% 2 2% ano 2 NO b INOT2 C 2.7

- 76-2.7.4.2- CINRGI INO-/2 INOT2 Ohmeda NO-3 CINRGI INO-/2 INOT2 Ohmeda NO-3 NO 2 ppm NO 5 ppm NO 2 ppm NO 8 ppm NO 2 ppm NO 5 ppm NO 2 ppm NO 8 ppm N 2 a N a N 4 N 4 N 36 N 37 N N 4 N 8 N 2 95 4 2 2 3 22 9 6 6 83 6 92 2 2 4 9 8 9 2 5 7 7% 8 7% 2% 2% 3% 9% 9% 9% 9% 9% % 2% 2% 2% % 2 2% 2 2% % 3% 3% % % 2 2% 2 2% 2% 2% 3% % 9% % % % % % 3% 3% 4 4% 6 6% % 5 5% 3% 3% 2 2% 7 7% 3 3% 5 5% 3% 3% 5 5% 6 6% 6 5% 9 8% 2% 3% 9% ano 2 NO 2.7

- 77-2.7.4.2- CINRGI INO-/2 INOT2 Ohmeda NO-3 CINRGI INO-/2 INOT2 Ohmeda NO-3 NO 2 ppm NO 5 ppm NO 2 ppm NO 8 ppm NO 2 ppm NO 5 ppm NO 2 ppm NO 8 ppm N 2 a N a N 4 N 4 N 36 N 37 N N 4 N 8 N 2 95 4 2 2 3 22 9 6 6 83 6 92 2 2 4 9 8 9 2 5 % 3% 2 2% 3 3% 2 2% % 2 2% % 2% % 2% 3% % 9% 9% 9% % 2 2% % 2 2% 9% % 3% 3 3% 2 2% 2 2% 4 3% 2 2% % 3% 2 8% % 2 2% % % ano 2 NO 2.7

- 78-2.7.4.2- CINRGI INO-/2 INOT2 Ohmeda NO-3 CINRGI INO-/2 INOT2 Ohmeda NO-3 NO 2 ppm NO 5 ppm NO 2 ppm NO 8 ppm NO 2 ppm NO 5 ppm NO 2 ppm NO 8 ppm N 2 a N a N 4 N 4 N 36 N 37 N N 4 N 8 N 2 95 4 2 2 3 22 9 6 6 83 6 92 2 2 4 9 8 9 2 5 % % % % % % % % % 3 3% % 2 2% % 9% 9% 9% 9% 9% 2% % % 9% 9% % 6 6% 8 8% 2 2% 9% 2% 3% 9% 2 25% 4 4% 3 3% 2 2% 3 3% ano 2 NO 2.7

- 79-2.7.4.2- CINRGI INO-/2 INOT2 Ohmeda NO-3 CINRGI INO-/2 INOT2 Ohmeda NO-3 NO 2 ppm NO 5 ppm NO 2 ppm NO 8 ppm NO 2 ppm NO 5 ppm NO 2 ppm NO 8 ppm N 2 a N a N 4 N 4 N 36 N 37 N N 4 N 8 N 2 95 4 2 2 3 22 9 6 6 83 6 92 2 2 4 9 8 9 2 5 % 3% % % % % 2% 5 5% % 3 3% 5 5% 2 2% % 7 6% 2 2% 3 35% % % % b 24 24% 23 23% 9 7% 26 24% 2% 3% 2 8% b 2 25% 5% WBC % 9% 9% 9% (9.%) 4 4% 2 2% % 2 8% % 6 6% 2 2% 7 6% 23 2% 2 5% 4 % 2 6% 3% 3% 3% ano 2 NO b INOT2 2.7

- 8-2.7.4.2- CINRGI INO-/2 INOT2 Ohmeda NO-3 CINRGI INO-/2 INOT2 Ohmeda NO-3 NO 2 ppm NO 5 ppm NO 2 ppm NO 8 ppm NO 2 ppm NO 5 ppm NO 2 ppm NO 8 ppm N 2 a N a N 4 N 4 N 36 N 37 N N 4 N 8 N 2 95 4 2 2 3 22 9 6 6 83 6 92 2 2 4 9 8 9 2 5 BUN 2 2% 2 2% 3% % % % 7 7% 4 4% 5 5% 5 5% 2 8% % 2 2% % 2 2% % 7 7% 3 3% 7 6% 3% 3 3% 6 6% % 2 2% % 4 4% 3 3% % 5 5% % 4 4% 2% 3% % % % 3% 8 8% % 9% 8 7% 2% 3% 8 8% % 2 2% % 6 6% 3 3% 2 2% 4 4% 2% 3% 3 3% % NPN 9 9% 2 2% 6 5% % 2 2% ano 2 NO 2.7

- 8-2.7.4.2- CINRGI INO-/2 INOT2 Ohmeda NO-3 CINRGI INO-/2 INOT2 Ohmeda NO-3 NO 2 ppm NO 5 ppm NO 2 ppm NO 8 ppm NO 2 ppm NO 5 ppm NO 2 ppm NO 8 ppm N 2 a N a N 4 N 4 N 36 N 37 N N 4 N 8 N 2 95 4 2 2 3 22 9 6 6 83 6 92 2 2 4 9 8 9 2 5 b % 4 36% b 9% % 3% % 3% % % % 9% 4 4% % % % 3% % % 2% 3% % 2% 3% 7 7% 5 5% 3 3% 8 7% 2 5% 2 5% 2(6%) 3% 3% 3% 9% 2 25% % % 3% 3% 2 2% % % % % % % 2 2% % 3% 3% ano 2 NO b INOT2 2.7

- 82-2.7.4.2- CINRGI INO-/2 INOT2 Ohmeda NO-3 CINRGI INO-/2 INOT2 Ohmeda NO-3 NO 2 ppm NO 5 ppm NO 2 ppm NO 8 ppm NO 2 ppm NO 5 ppm NO 2 ppm NO 8 ppm N 2 a N a N 4 N 4 N 36 N 37 N N 4 N 8 N 2 95 4 2 2 3 22 9 6 6 83 6 92 2 2 4 9 8 9 2 5 % 3 3% 5 5% 9% 9% 9% % % 2% 3% 25% 3% 5% 7 7% 4 4% 8 7% 2 2% 2 8% % % 9% % 2% 2% % % 3% % % % 2 2% % 2 2% 2 2% % 2% 2% 9% % % 3 3% 2 2% % 2 2% 2 5% 2 5% 3% 3% 3% 2 25% 5% 3 3% % % 3% % % % 9% ano 2 NO 2.7

- 83-2.7.4.2- CINRGI INO-/2 INOT2 Ohmeda NO-3 CINRGI INO-/2 INOT2 Ohmeda NO-3 NO 2 ppm NO 5 ppm NO 2 ppm NO 8 ppm NO 2 ppm NO 5 ppm NO 2 ppm NO 8 ppm N 2 a N a N 4 N 4 N 36 N 37 N N 4 N 8 N 2 95 4 2 2 3 22 9 6 6 83 6 92 2 2 4 9 8 9 2 5 3 3% 3 3% % 5 5% 3% 9% % % 2 2% 2% 2 2% % % 9% 2% 4 % 3 8% 3 8% % 9% 9% 3% % 2 2% % % 2 2% % 4 4% 2% 9% 9% 9% % % b % % % 4 36% b % % 3 3% 9% % c 2 8% c ano 2 NO b INOT2 c INOT2 2.7

- 84-2.7.4.2- CINRGI INO-/2 INOT2 Ohmeda NO-3 CINRGI INO-/2 INOT2 Ohmeda NO-3 NO 2 ppm NO 5 ppm NO 2 ppm NO 8 ppm NO 2 ppm NO 5 ppm NO 2 ppm NO 8 ppm N 2 a N a N 4 N 4 N 36 N 37 N N 4 N 8 N 2 95 4 2 2 3 22 9 6 6 83 6 92 2 2 4 9 8 9 2 5 % 9% % % % 2 2% 2 2% % 3% 9% % % % % 9% % 3 3% 5 5% 4 4% 5 5% % % 3 3% 2% 3% 3% % % 2% % _ 7 7% % 9% 2 2% 2% 3% ano 2 NO 2.7

2.7 CINRGI INO-/2 Ohmeda NO-3 NINOS 2.7.4.2-2 - 85 -

- 86-2.7.4.2-2 CINRGI INO-/2 Ohmeda NO-3 NINOS 2 3 4 5 6 7 2 3 N 264 N 89 N 57 N 37 N 22 N 4 N 2 N 8 N 3% 2 % 5% 3% 3% 2% 4 2% % 2% 3% % 3% 2% 3 38% 2% % 3 38% 5% 4 5% % 3% 5 63% 2 % % 8% % 2% 3% 3% 3% 8% % 4 4% 3% 3% % % 2 5% 5% 3 38% 5 2% % 2% 3% 3% 2 % 2.7

- 87-2.7.4.2-2 CINRGI INO-/2 Ohmeda NO-3 NINOS 2 3 4 5 6 7 2 3 N 264 N 89 N 57 N 37 N 22 N 4 N 2 N 8 N 4 5% 3% 2% 7% 3% % 7% 4 5% 3% % 7% % % 2 25% 3% % 6 2% 2 2% 2 4% 2 5% 5% 7% 8% 5 2% 5 2% % 3% 2 % 5% 2 25% 8 3% 5 6% 3 5% 5% % 3% 8 7% 4 6% 4 7% 7 9% 5% 2 4% 2 25% 2.7

- 88-2.7.4.2-2 CINRGI INO-/2 Ohmeda NO-3 NINOS 2 3 4 5 6 7 2 3 N 264 N 89 N 57 N 37 N 22 N 4 N 2 N 8 N 8% 7 3% 6 7% 2 4% 5 4% 5% 7% 8% 4 5% BUN 7% 8% % 8% 7 3% 2 4% 3% % 7% 3% 5 2% % 3% 2% 8% 5 63% 2 % 2 2% 3% % 4 2% % 5% % 4 5% 3 3% 2 5% 3% 6 2% 2 2% 8% 7 3% 2% 3% 7% % NPN 2 2% 2 4% 3% 2 9% 7% 3% % % 3% GOT % 2.7

- 89-2.7.4.2-2 CINRGI INO-/2 Ohmeda NO-3 NINOS 2 3 4 5 6 7 2 3 N 264 N 89 N 57 N 37 N 22 N 4 N 2 N 8 N 3% 2 % % 7% 3% % 4 4% 2% 5% 4 29% 3% 3% 5% 3% % 3% 3% 5% 2 % 3 3% 5 9% 3% 3% 3% 7% 5% 5% 4 2% 3% 3% % 2% 2 9% % 3% 3% 3% 3% 6 2% % 5% 7% 2 25% % 5% 5% 7% 8% 2.7

- 9-2.7.4.2-2 CINRGI INO-/2 Ohmeda NO-3 NINOS 2 3 4 5 6 7 2 3 N 264 N 89 N 57 N 37 N 22 N 4 N 2 N 8 N 2% % 3% 3% 3% 4 2% % 3% 2% % % 3% 3% 2 % 2 2% 2 4% 3% 2.7

- 9-2.7.4.2-2 - NO 5 ppm -CINRGI INO-/2 Ohmeda NO-3 NINOS 2 3 4 5 6 7 2 3 NO 5 ppm N 45 N 29 N 23 N 8 N 5 N 9 N 5 N 4 N 4% 3% 25% 2 7% 4% 2% 2% 3% 4% 6% 2% 2% 3% 3% % 2.7

- 92-2.7.4.2-2 - NO 2 ppm -CINRGI INO-/2 Ohmeda NO-3 NINOS 2 3 4 5 6 7 2 3 NO 2 ppm N 268 N 58 N 4 N 93 N 7 N 35 N 2 N 4 N 7% 7% % 3% 7% % 7% % % % % 7% 3% 5% 3 2% 7% 5 36% 3% 5 36% 2 3% 3 2% % % % % 7% % % 7% % % % 3 4% 3 2% % 5 36% 7 3% 4 3% % 2 2% 7% 2 % 2.7

- 93-2.7.4.2-2 - NO 2 ppm -CINRGI INO-/2 Ohmeda NO-3 NINOS 2 3 4 5 6 7 2 3 NO 2 ppm N 268 N 58 N 4 N 93 N 7 N 35 N 2 N 4 N 7% % % 5% % 7 5% 5% % 7% % 7% 2 4% 7% 4 % 3 3% 2 2% 3% 3 2% % % 5% 7% % % % % % 7% 2 % % 4 4% 2 % 7% 2 8% 7% 3 3% 3 3% % 3 9% 7% % 7% 4 % 7 4% 8 7% 4 4% 4 6% 2 4% BUN % 7% 7% 2.7

- 94-2.7.4.2-2 - NO 2 ppm -CINRGI INO-/2 Ohmeda NO-3 NINOS 2 3 4 5 6 7 2 3 NO 2 ppm N 268 N 58 N 4 N 93 N 7 N 35 N 2 N 4 N % 5 2% 2 % % 5% % % % 7% 5 2% 2 % % 2 4% 5% % % % 6 2% 7% 2 4% 3 2% 2 2% % 2 % % 4 % 2 % % % 5% NPN % 3 2% % 2 4% 5% 7% % 2 4% 2 4% 3 % 4 3% 2 2% 3 4% 2 4% % 5% % % % 7% 3% 4 29% 2.7

- 95-2.7.4.2-2 - NO 2 ppm -CINRGI INO-/2 Ohmeda NO-3 NINOS 2 3 4 5 6 7 2 3 NO 2 ppm N 268 N 58 N 4 N 93 N 7 N 35 N 2 N 4 N % 3 2% % 2 3% 3% 5% 7% % 5% 2 6% 7% % % % % % 5% 2 4% % % % % 3% 2 4% % 6 2% % 2 2% 3% 7% % % 3 2% 7% 7% 7% 7% % 7% 4 % 2 % % 3% 3 % 7% % 2.7

- 96-2.7.4.2-2 - NO 8 ppm -CINRGI INO-/2 Ohmeda NO-3 NINOS 2 3 4 5 6 7 2 3 NO 8 ppm N 39 N 2 N 3 N N 9 N 8 N 3 N N 2 5% 3% 8% 8% % 3% % % 3% 2 3% 5% 5% % 3% 3% % % 3% 5% % 2.7

- 97-2.7.4.2-2 - NO 8 ppm -CINRGI INO-/2 Ohmeda NO-3 NINOS 2 3 4 5 6 7 2 3 NO 8 ppm N 39 N 2 N 3 N N 9 N 8 N 3 N N % 3% 3% 8% % % 2.7

2.7 2) INO-/2 NINOS 2.7.6.3.3 2.7.6.3.7 5 5.3.5.4-4 5.3.5.4-5 a) INO-/2 INO-/2 5.3.5.4-4 55 32 NO P.9 2.7.4.2-3 2.7.4.2-3 -INO-/2 - NO 5 ppm 2 ppm 8 ppm 36 36 29 3 96 4 3 7 %.%.% 3.8%.3% 7.3% - - 3.. 2.2 SD - -.7..6 - - 4... - - 4 4 Fisher NO P=.9 NO NO Fisher P=.9 2.7.4.2-4 - 98 -

2.7 2.7.4.2-4 -INO-/2 - NO 5 ppm 2 ppm 8 ppm cm 75.9 77.5 78. 77. 77.5 SD 3.79 5.62 6.3 5.2 5.53 75.8 76. 77. 77. 77. 32 32 24 27 83 P a -.7.4.32.8 kg..3.5..3 SD.29.69.84.58.69.2. 9.9.. 32 35 25 28 88 P a -.54.33..53 cm 46.5 46.2 46.7 45.9 46.3 SD 2.9 2.4 2.8.72 2.36 46.3 46. 46.5 45.9 46. 33 34 26 26 86 P a -.6.67.3.69 a t- 3 2.7.4.2-5 2.7.4.2-6 2.7.4.2-5 -INO-/2 - NO 5 ppm 2 ppm 8 ppm 36 36 29 3 96 28 3 2 23 74 % 77.8% 86.% 69.% 74.2% 77.% 3 2 4 % 8.3% 2.8% 6.9% 3.2% 4.2% 4 3 5 5 3 %.% 8.3% 7.2% 6.% 3.5% 2 2 5 % 2.8% 2.8% 6.9% 6.5% 5.2% P a -.45.49.72.9 a Cochran-Mantel-Haenszel χ 2-99 -

2.7 2.7.4.2-6 -INO-/2 - NO 5 ppm 2 ppm 8 ppm 36 36 29 3 96 33 35 24 26 85 % 9.7% 97.2% 82.8% 83.9% 88.5% 2 4 3 7 % 5.6%.% 3.8% 9.7% 7.3% 2 4 % 2.8% 2.8% 3.4% 6.5% 4.2% P a -.5.25.5.7 a Cochran-Mantel-Haenszel χ 2 Bayley 2 The Psychological Corporation San AntonioBayley 5 2 2 Bayley BSID-2 Mental Development Index, MDIMDI 5 85 MDI 5 7 MDI 855 MDI 7 MDI 5 2.7.4.2-7 2.7.4.2-7 Bayley -INO-/2 - NO MDI 5 ppm 2 ppm 8 ppm 36 36 29 3 96 2 2 2 5 % 5.6% 5.6% 3.4% 6.5% 5.2% 22 2 7 7 55 % 6.% 58.3% 58.6% 54.8% 57.3% 7 6 2 5 3 % 9.4% 6.7% 6.9% 6.% 3.5% 2 3 2 7 % 2.8% 5.6%.3% 6.5% 7.3% 2 4 2 7 % 5.6% 2.8% 3.8% 6.5% 7.3% 2 4 2 3 9 % 5.6%.% 6.9% 9.7% 9.4% P a -.85.23.73.57 a Cochran-Mantel-Haenszel χ 2 Psychomotor Development Index, PDIPDI 5 85 PDI 5 7 PDI 855 PDI 7 PDI 5 2.7.4.2-8 - -

2.7 2.7.4.2-8 Bayley -INO-/2 - NO PDI 5 ppm 2 ppm 8 ppm 36 36 29 3 96 3 4 2 7 % 8.3%.% 3.4% 6.5% 7.3% 24 2 6 2 58 % 66.7% 58.3% 55.2% 66.7% 6.4% 4 2 3 6 %.% 5.6%.3% 3.2% 6.3% 3 2 6 %.% 8.3% 6.9% 3.2% 6.3% 2 2 4 3 9 % 5.6% 5.6% 3.8% 9.7% 9.4% 3 4 3 3 % 8.3%.%.3% 9.7%.4% P a -.67.8.55.28 a Cochran-Mantel-Haenszel χ 2 2.7.4.2-9 2.7.4.2-9 -INO-/2 - NO 5 ppm 2 ppm 8 ppm 36 36 29 3 96 23 23 9 8 6 % 63.9% 63.9% 65.5% 58.% 62.5% 7 2 4 4 % 9.4% 5.6% 3.8% 2.9%.4% 2 %.% 2.8%.% 3.2% 2.% 6 6 8 24 % 6.7% 27.8% 2.7% 25.8% 25.% P a -.5.6.84.69 a Cochran-Mantel-Haenszel χ 2 BSID-2 PDI MDI 25 db.5 2 khz BSID-2 PDI 85 MDI 85 25 5 db.5 2 khz BSID-2 PDI 7 85 MDI 7 85 2 2 5 db.5 2 khz BSID-2 PDI 7 MDI 7 - -

2.7 2.7.4.2-5.% NO 54.2% 2.7.4.2- -INO-/2 - NO 5 ppm 2 ppm 8 ppm 36 36 29 32 97 8 23 4 5 52 % 5.% 63.9% 48.3% 48.4% 54.2% 2 6 6 7 9 % 33.3% 6.7% 2.7% 22.6% 9.8% 5 7 8 7 22 % 3.9% 9.4% 27.6% 22.6% 22.9% 2 3 % 2.8%.% 3.4% 6.5% 3.% P a -.69.44.63.76 a Cochran-Mantel-Haenszel χ 2 b) NINOS 2 NINOS 5.3.5.4-5 NINOS 2 2 99 73 2.7.4.2-2.7.4.2-2 NINOS - NO kgsd.8 2. 2..9 85 83 cmsd 82.9 6.2 83.7 4.6 85 82 cmsd 47.9 2. 48. 2.4 84 83 head control 2.7.4.2-2 - 2 -

2.7 2.7.4.2-2 2 -NINOS - N 87 NO N 85 69 66 % 79.3% 77.6% 3 % 3.4%.% 2 2 % 2.3% 2.4% 3 2 % 3.4% 2.4% 2 %.% 2.4% 5 4 % 5.7% 4.7% 4 4 % 4.6% 4.7% 9.%9.3% NO.8% 2.7.4.2-3 3 7 8.% NO 6 7.% 2.7.4.2-3 2 -NINOS - N 87 NO N 84 9 %.3%.9% 2 4 % 2.3% 4.8% 2 % 2.3%.2% 5 5 % 5.7% 6.% 72 7 9.9% 7 3 4.9%NO 4 4.7%NO Fisher P.39 8% NO 57 9.8% 2.7.4.2-4 - 3 -

2.7 2.7.4.2-4 2 -NINOS - N 82 NO N 75 59 5 % 72.% 68.% 2 % 4.6% 3.3% 2 4 % 2.4% 5.3% 9 %.% 3.3% 2.7.4.2-5 Bayley 2 MDISD 87. 8.7 NO 85. 2.7 2.7.4.2-6 PDISD 93.6 7.5 NO 85.9 2.2 7 2SD % MDI PDI 5 2.7.4.2-5 2 MDI -NINOS - N 73 NO N 77 SD 87. 8.7 85. 2.7 MDI 5 5 6 % 6.8% 7.8% MDI 5-69 9 5 % 2.3% 9.5% MDI 7-84 2 9 % 6.4%.7% MDI 85-99 29 2 % 39.7% 27.3% MDI 8 26 % 24.7% 33.8% 2.7.4.2-6 2 PDI -NINOS - N 75 NO N 78 SD 93.6 7.5 85.9 2.2 PDI 5 3 9 % 4.%.5% PDI 5-69 6 8 % 8.%.3% PDI 7-84 4 2 % 5.3% 5.4% PDI 85-99 27 25 % 36.% 32.% PDI 35 24 % 46.7% 3.8% - 4 -

2.7 (2) NO 2.7.4.2.. CINRGI INO-/2 INOT2 Ohmeda NO-3 5% 2.7.4.2-7 NO 5% 49/24939/2492/2492/2499/249 8/249 6/2496/2495/249 NO - 5 -

- 6-2.7.4.2-7 5% CINRGI INO-/2 INOT2 Ohmeda NO-3 CINRGI INO-/2 Ohmeda INOT2 NO-3 NO NO N 2 a N a N 4 N 4 N N 4 % 5 5% 2 4% % 3 3% 9% 8 8% 7 6% 6 6% 8 7% 9% % 7% 3 3% 6 5% 6 6% 8 7% 2 5% 3 3% 7 7% 8 7% 2% % 9% 9% 9% 9% % 6 5% 2 2% 9 9% 8 7% 2 2% % 5 4% 2 2% 9% 9% 9% 9% 3 3% 3 3% 9% 5 5% 6 5% 2 8% ano 2 NO 2.7

- 7-2.7.4.2-7 5% CINRGI INO-/2 INOT2 Ohmeda NO-3 CINRGI INO-/2 Ohmeda INOT2 NO-3 NO NO N 2 a N a N 4 N 4 N N 4 % 9% 9% 9% 9% 9% % 9% 9% 4 4% 2 % 2% % 9% 2 4% 7 7% 5 5% 6 6% 3 3% 7 7% 8 7% 2 2% 3 % 47 46% 45 4% 2% 2 8% 3 2% 9% 9% 9% 9% 4 4% 3 3% 2 8% 26 25% 3 27% 2 5% 8 7% 7% 7% % 9% 2 8% 7 7% 9% 7% ano 2 NO 2.7

- 8-2.7.4.2-7 5% CINRGI INO-/2 INOT2 Ohmeda NO-3 CINRGI INO-/2 Ohmeda INOT2 NO-3 NO NO N 2 a N a N 4 N 4 N N 4 9 9% 7% 9 9% 8 6% 7% 9 9% 9 9% 6 5% NPN 9 9% 8 7% GPT 9% GOT % 3 27% 9% % 7% % 9% 5 5% 2 2% 7% 2 2% 2% 7% 2 2% % 7 6% 9% 2 4% 9% 9% 9% % 2 2% 3 2% % 9% 2 8% 9% 2 2% 3 3% 2 5% 3 3% 9% ano 2 NO 2.7

- 9-2.7.4.2-7 5% CINRGI INO-/2 INOT2 Ohmeda NO-3 CINRGI INO-/2 Ohmeda INOT2 NO-3 NO NO N 2 a N a N 4 N 4 N N 4 5 5% 3 3% 2 5% 5 4% 3 2% 2 2% % 9% 6 6% 6 5% % 9% 3 3% % 2% 9% % 9% 9% 9% 9% 9% 2 2% % 4 36% 2 8% % 9% 3 3 2 2 9% 9% 8 8% 9 8% % 3 3% 2% % 7% 7 7% % 9% ano 2 NO 2.7

2.7 2.7.4.2..- CINRGI INO-/2 INOT2 Ohmeda NO-3 5 8 ppm 34%3/38 2 ppm % 2/64 5 ppm NO MetHb.2 %NO MetHb MetHb MetHb MetHb CINRGI 4% INO-/2 Ohmeda NO-3 7% INOT2 5%INO-/2 MetHb 7% INO-/2 MetHb 2 ppm MetHb % 2.7.4.2-2.7.4.2-8 8 ppm 5% MetHb INO-/2 8 ppm 7% MetHb 36 3 36%8 ppm 37 MetHb 36 2.7.4.2- MetHb SE - INO-/2 - - -

2.7 2.7.4.2-8 MetHb SD -INO-/2 - NO 2 3 4 8 2 6 2 24 28 32 36 4 44 48 N 36 a 35 36 35 34 33 24 23 2 9 8 7 6 6 4 2.38.79 2.79 3.43 4.22 5.4 5.8 4.33 4.22 4.7 4.9 3.46 3.24 3.22 3.29 3.23 8 ppm SD.28.94.32.88 2.46 2.75 2.32.65.54.53.65.56.8.99.9 2.2...5....9.2.7.5.5..4.5.9.. 3.8 5.7 7.8.8.9.4 7.3 6.8 6.7 7.3 6.6 6.9 7.2 6.7 7.6 N 36 35 34 33 33 3 27 26 25 23 22 2 2 8 8 6.5.69.8.88.96.5.89.97.98.94.97.95.95.87.9.89 2 ppm SD.38.39.43.5.56.65.5.54.53.57.5.5.52.5.44.44.....3......2....3..5.6.8 2.2 2.6 3.5 2. 2.8 2.5 2.3 2.2 2. 2.2 2..9.9 N 4 37 39 39 38 37 33 3 28 26 24 23 24 22 2 2.4.5.52.56.57.64.62.68.64.67.68.73.69.55.56.64 5 ppm SD.3.53.6.56.54.64.7.75.83.76.83.9..38.32.45................. 3. 3.4 3.2 3. 3.5 4. 4.2 4.4 4. 4.2 4.6 5.6.4.4.7 N 39 b 39 35 33 3 3 27 26 23 22 22 2 9 9 7 8.5.46.4.43.45.38.46.47.47.45.48.45.46.49.46.57 SD.4.39.36.4.39.37.4.36.48.44.38.42.36.4.37.46.................6.6.5.9.9.7.6.7.7.7.6.7.4.6.6.6 a 8 ppm 37 MetHb 36 b 4 MetHb 39 INO-/2 7% MetHb MetHb.46 9.46 SD 8 7% 4 2 5 ppm 7% MetHb CINRGI MetHb 2.7.4.2-2 NO MetHb NO MetHb P..5 Methemoglobin Levels in Percent.3..8.5.3 Inhaled NO Placebo. 6 2 8 24 3 36 42 48 54 6 66 72 78 84 9 96 Hours 2.7.4.2-2 MetHb SE -CINRGI - - -

2.7 INOT2 MetHb 2% MetHb 2.7.4.2-3 2.5 MetHb (%) 2.5.5 # # 2 # 22 # 3 # 32 # 4 # 53 # 54 # 6 # 7 # 8 hr 4 hr 2 hr 24 hr 48 hr 72 hr 96 hr 2 hr Hours Post Dose 44 hr 68 hr 92 hr cmpl/discn 2.7.4.2-3 MetHb % -INOT2 - INO-/2 CINRGI Ohmeda NO-3 MetHb 2 ppm MetHb 2% 8 ppm 34% 3/38 7% MetHb NO 8 MetHb INO-/2 4 INOT2 NO MetHb 2 ppm 2.7.4.2..2 CINRGI INO-/2 Ohmeda NO-3 3 2.7.4.2-9 NO 2/43 8% 8/224 8% NO 7 2.7.4.2-9-2 CINRGI -3 INO-/2 CINRGI INO-/2 2.7.4.2-9-4 INOT2 NO ECMO NO - 2 -

2.7 2.7.4.2-9 CINRGI INO-/2 a N 44 c NO N 222 3 9.% b 8 8.%.7% b.5%.7% b 2.9% 2.9%.5% 2.4% b 2.9%.7% b 2.9%.7% 2.9% 2.4%.7%.7% b.5%.7% b.7% b.5%.5% 2.4% b 3.4%.7% b.7% b.5%.7% b NPN.5%.7%.7%.5%.5%.5%.5%.5%.7% b.5%.7% b.5%.7%.7% b 7 3.2%.7% b.5%.7% b.7% b.7% b 2.9%.7% a b CINRGI c CINRGI 4 3-3 -

2.7 2.7.4.2-9-2 CINRGI 3. kg 9 33 35 3 2 ( ) (5 ) 4 3 24 9 7 2.9 kg 9 37 24 ( ) (5 ) 3 9 9 2 9 2 3 ECMO 9 ECMO 39 4 3 4.3 kg 9 4 29 7 ( ) (5 ) 2 2 4 ECMO 9 9 4 3.8 kg 9 4 27 ( ) 7 (5 ) 8 4 2 ECMO ECMO 9 4 ECMO NO 9 3-4 -

2.7 2.7.4.2-9-2 CINRGI 5 3. kg 9 37 33 2 2 37 8 ( ) 7 (5 ) 9 B 9 5 ECMO ECMO ECMO 5 ECMO 9 2 6 NO 3.8 kg 9 4 7 ( ) 5 (5 ) 9 9 NO 8 ECMO ECMO 9 7 NO 3.4 kg 9 42 33 4 2 ( ) 5 (5 ) 9 9 NO HFOV 9 8 9 25 8 NO 2.6 kg 9 4 2 B ( ) 7 (5 ) 7 B 9 2 NO 96 9 8-5 -

2.7 2.7.4.2-9-2 CINRGI 9 NO 2 3.2 kg 9 4 3 3 ( ) 6 (5 ) 8 9 ECMO ECMO ECMO 9 22 ECMO 9 4 3. kg 9 39 25 3 2 B ( )4 (5 ) 6( )6 5 3 ECMO 9 3 ECMO 9 9 7 2.3 kg 9 37 38 ( ) 6 (5 ) 8 9 3 3.4 kg 9 4 3 2 2 ( ) (5 )3 9 2 4 ECMO 9 4 3 9 4-6 -

2.7 2.7.4.2-9-2 CINRGI 3 2.5 kg 9 38 3 3 ( ) 2 (5 ) 5 9 ECMO 2 ECMO ECMO 9 9 ECMO 9 2 9 3 9 33 4 2. kg 9 36 26 ( ) (5 ) 3 3 ECMO 9 6 9 9 ECMO NO NO 9 38 5 2.9 kg 9 38 27 3 2 ( ) 3 (5 )3 9 3 96 9 22 ECMO ECMO 9 33 262 ECMO 9 4-7 -

2.7 2.7.4.2-9-2 CINRGI 6 NO 7 NO 8 NO 9 NO 2.7 kg 9 39 8 2 ( ) (5 ) 5 9 NO 2 ECMO 9 4 ECMO 9 29 3.3 kg 9 39 27 3 ( ) 7 (5 ) 8 9 NO ECMO ECMO 9 22 9 6 3.2 kg 9 4 33 ( ) (5 ) 4 7 NO 3 ECMO ECMO 9 9 5 ECMO 9 2 9 24 3.6 kg 9 38 26 2 ( ) 5 (5 ) 6 9 NO 3 ECMO 9 ECMO 9 6 9 7 9 28-8 -

2.7 2.7.4.2-9-3 INO-/2 (INO-2) 2 (INO-2) 3 NO 5 ppm (INO-) 3.kg 9 38 25 2 2 8 5 9 9 2 9 4 9 6 9 9 9 SIDS 2.9kg 9 39 34 4 3 2 ( )6 5 7 9 () 8 2 49 XXXXY 9 5 3.2kg 9 4 2 2 ( )7 (5 )9 9 2 (5 ppm) 2 9 2 2 9 2-9 -

2.7 2.7.4.2-9-3 INO-/2 4 NO 5 ppm (INO-) 5 NO 2 ppm (INO-) 6 NO 2 ppm (INO-) 4.5kg 9 42 37 4 2 ( )4 (5 )7 9 (5 ppm) 25 7 9 7 ECMO 3.7kg 9 38 24 ( ) 8 (5 )9 3 9 (2 ppm) 5 6 mm Hg B 9 3 9 4 3.8kg 9 4 23 ( ) (5 ) 9 5 (2 ppm) 9 56 NO 9 62-2 -

2.7 2.7.4.2-9-3 INO-/2 7 NO 2 ppm (INO-) 8 NO 2 ppm (INO-) 4.kg 9 38 29 4 3 ( ) 8 (5 ) 8 3 9 (2 ppm)9 2 6.8 meq/l 9 5 9 6 ( ) 9 7 3.7kg 9 42 2 ( ) (5 ) 9 ( 2 ppm) 9( 56 ) - 2 -

2.7 2.7.4.2-9-3 INO-/2 9 NO 2 ppm (INO-) NO 8 ppm (INO-) 2.6kg 9 37 8 ( ) 4 (5 ) 9 9 (2 ppm) 2 ph 7.5 9 4 9 8 NO 3 9 33 2.8kg 9 4 29 2 2 ( ) 8 (5 )9 3 9 (8 ppm) PaO 2 33 (ECMO) ECMO NO ECMO 5 NO 9 2-22 -

2.7 2.7.4.2-9-3 INO-/2 NO 8 ppm (INO-) 2 NO 8 ppm (INO-) 4.kg 9 42 33 2 2 4 ( ) (5 ) 6 9 (8 ppm) 7% 32 ppm( 4%) 9 6 9 7 (ECMO) 9 9 4.2kg 9 4 2 2 2 ( ) 8 (5 )9 9 (8 ppm)9 3 2 9 3-23 -

2.7 2.7.4.2-9-4 CINRGI INO-/2 ID NO guhmas2 sjhcdh2 a sjhcdh2 a a CINRGI CDH NO apcdh2 a NO guhmas2 NO chcdh2 a NO echrds2 NO cmccdh a NO INO_ 73 NO cmcpn occdh a sjhcdh2 a cmccdh3 a NO INO_ 6 NO INO_ NO INO_ 5 appphn8 NO INO_ cmcpphn2 muscpn5 muscpn2 NO apcdh2 a sjhcdh2 a occdh a sjhcdh2 a NO musccdh a NO chcdh2 a NO chcdh2 a NO guhmas2 occdh a sjhcdh2 a NO apcdh2 a musccdh3 a occdh a NO echrds2 occdh a NPN NO apcdh2 a echpphn9 NO INO_ 325 muscpn5 NO INO_ 325-24 -

2.7 2.7.4.2-9-4 CINRGI INO-/2 ID NO echrds2 NO echrds5 NO guhmas2 NO INO_ 323 chcdh a sjhcdh2 a NO chcdh2 a INO_2 55 NO INO_ 5 NO INO_ 2 NO INO_ 66 NO echrds5 NO guhmas2 NO musccdh a sjhcdh2 a NO INO_ akrcdh2 a NO INO_ 326 sjhcdh2 a occdh a sjhcdh2 a NO chcdh2 a NO musccdh a a CINRGI CDH 2.7.4.2..3 CINRGI INO-/2 INOT2 Ohmeda NO-3 2.7.4.2-2 24/29-25 -

- 26-2.7.4.2-2 CINRGI INO-/2 INOT2 Ohmeda NO-3 CINRGI INO-/2 INOT2 a N 2 b 2 ppm N b N 4 5 ppm N 4 a bno 2 NO 2 ppm N 36 8 ppm N 37 2 ppm N 5 ppm N 4 Ohmeda NO-3 2 ppm N 8 8 ppm N 2 (2%) (2%) (3%) (3%) (3%) (3%) (9%) (9%) (9%) (3%) (2%) (3%) (3%) (3%) (9%) (2%) (3%) (9%) (2%) (2%) 2 (6%) (3%) (3%) (3%) (9%) (9%) (3%) (9%) 2.7

2.7 () 2.7.4.2-2 NO NO CINRGI 2.7.4.2-2 CINRGI INO-/2 NINOS NO P 9/89 2.3% INO-/2 a 3/4 7.3% NINOS b 9/2 5.7% 4/25 6.3% a NO 28 b NO Fisher 7/97 7.5% 6/4 5.3% 8/4 5.8% 4/325 2.6%.58.7..23 (2) NO 2.7.4.2-22NO 2.7.4.2-22 CINRGI INO-/2 NINOS NO P CINRGI a /89.2% INO-/2 a 7/4 7.% 24/2 NINOS b 9.8% 4/25 6.3% /97.3% 22/2 9.6% 6/4 4.% 48/323 4.9% a NO 28 b NO Fisher..82.3.64-27 -

2.7 2.7.4.2..4 CINRGI INO-/2 2.7.4.2-23 NO MetHb 2.7.4.2... 2.7.4.2-23 CINRGI INO-/2 COSTART a N 44 NO N 222 P b 2.4% 7 7.7%.77 %.5%. %.5%. %.5%. % 5.%.83.7%.5%. %.5%. %.5%..7% %.3896 a b Fisher 2.7.4.2..5 2.7.4.2-26/249 CINRGI INO-/2 NO 8 ppm 2.7.4.2.2-28 -

2.7 2.7.4.3 CINRGI INO-/2 Ohmeda NO-3 INOT2 2.7.4.3-2.7.4.3-23 3 INOT2 2.7.4.3-2.7.4.3-2 NO INOT2 2 Jaundice cholestatic Obstructive jaundice Thrombocytopenia neonatal Thrombocytopenia - 29 -

2.7 9 8 RBC (x^6/mm^3) 7 6 5 4 3 2 Pre-Treatm Post Treatment Treatment NO 2.7.4.3-6 /mm 3 -CINRGI, INO-/2 Ohmeda NO-3-6. x 6 cells/mm 3 5. 4. 3. 2.. 2 22 3 32 4 53 54 6 7 8. Baseline Completion 2.7.4.3-2 6 cells/mm 3 -INOT2 - - 3 -

2.7 8 72 64 WBC (x^3/mm^3) 56 48 4 32 24 6 8 Pre-Treatm Post Treatment Treatment NO 2.7.4.3-3 3 /mm 3 -CINRGI, INO-/2 Ohmeda NO-3-2. x 3 cells/mm 3. 8. 6. 4. 2. 2 22 3 32 4 53 54 6 7 8. Baseline Completion 2.7.4.3-4 3 cells/mm 3 -INOT2 - - 3 -

2.7 22 2 8 Total Hemoglobin (gm/dl) 6 4 2 8 6 4 2 Pre-Treatme Post Treatment Treatment NO 2.7.4.3-5 mg/dl -CINRGI, INO-/2 Ohmeda NO-3 - g/dl 25. 2. 5.. 5.. Baseline Completion 2 22 3 32 4 53 54 6 7 8 2.7.4.3-6 gm% -INOT2 - - 32 -

2.7 7 6 5 Hematocrit (gm%) 4 3 2 Pre-Treatm Post Treatment Treatment NO 2.7.4.3-7 % -CINRGI, INO-/2 Ohmeda NO-3 - INOT2 8 72 64 56 Bands (%) 48 4 32 24 6 8 Pre-Treatme Post Treatment Treatment NO 2.7.4.3-8 % -CINRGI, INO-/2 Ohmeda NO-3 - INOT2-33 -

2.7 22 2 8 6 4 Eosinophils (%) 2 8 6 4 2 Pre-Treatme Post Treatment Treatment NO 2.7.4.3-9 % -CINRGI, INO-/2 Ohmeda NO-3 - INOT2 8 6 4 2 Basophils (%) 8 6 4 2 Pre-Treatm Post Treatment Treatment NO 2.7.4.3- % -CINRGI, INO-/2 Ohmeda NO-3 - INOT2-34 -

2.7 9 8 7 6 Lymphocytes (%) 5 4 3 2 Pre-Treatm Post Treatment Treatment NO 2.7.4.3- % -CINRGI, INO-/2 Ohmeda NO-3 - INOT2 3 27 24 2 Monocytes (%) 8 5 2 9 6 3 Pre-Treatm Post Treatment Treatment NO 2.7.4.3-2 % -CINRGI, INO-/2 Ohmeda NO-3 - INOT2-35 -

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