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1 8ppm 2 2.7
2 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
3 PD
4 NO 992 PPHN Roberts Lancet ) NO NO 8% ) NO NO CTN:NO , ppm ICR ppm RDR-76-DD ) MetHb 2, ppm NO CTN-NO ICR ,9 ppm CTN:NO , ppm Ohmeda NO ppm 4 ppm 8 ppm,6 ppm CINRGI INO Therapeutics, Inc. 8 ppm INO-/ ppm 4 ppm,6 ppm INOT INO Therapeutics, L.L.C. 8 ppm NINOS ppm INOSG , ppm NO
5 NO NO ppm % NO sgccgmp cgmp cgmp NOHb MetHbNO NO NO NO MetHb NO MetHb OI NO OI CTN:NO NO cgmp 4) ICR in vivo CTN:NO- -633/
6 NO MetHb NO 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 INO-/2 CINRGI NINOS AW-ME NO MetHb GCP/ GCP GCP GCP GCP PPHN GCP GCP GCP a 3) MetHb () NO MetHb CTN:NO CTN-NO ) MetHb RDR-76-DD CTN-NO- -8 RDR-76-DD CTN:NO NO 4 ppm 2 MetHb MetHb - 3 -
7 2.7 ICR N NO 2 ppm 8 ppm ) 5 N- cgmp CTN-NO- -8 NO NO 25 ppm 6 MetHb NOHb in vivo NO ppm NO NO 5 2 µmol/l in vitro NO RDR-76-DD 3) MetHb NO MetHb (2) MetHb NO ppm 4 INO-/ MetHb MetHb NO 2 ppm INOT MetHb MetHb NO PPHN ppm NO NO OI CTN:NO- -3 NO NO ICR 342 ) 2 ppm 8 ppm 8 ppm 72 ppm - 4 -
8 in vivo NO NO in vivo in vivo NO 4 ppm 2 CTN:NO MetHb CTN:NO NO/N 2 3% NO 4 ppm MetHb NO MetHb NO.63.6%.3.2%p. >5% MetHb (%) 2 Vol. Vol. 2 Vol. 3 Vol. 4 Vol. 5 Vol. 6 Vol. 7 Vol. 8 Vol. 9 Vol. Vol. Vol NO MetHb - 5 -
9 cgmp ICR ppm 2) 5 NO 5 N- 5 N- T max.42 5 N- 5 N-2 8 ppm 5 N- C max SD µmol/l AUC - SD 2 8 ppm µmol hr/l 5 N- T max T /2 CL/F Vd/F 5 N % N- 2 ppm 8 ppm 6 6 T max SD C max µmol/l SD SD T / SD CL/FL/hr SD Vd/FL ±SD AUC - µmol hr/l N 72 2 ppm 8 ppm 6 6 µmol SD % SD cgmp 2 ppm 8 ppm cgmp cgmp GLP 2) 2 ppm 8 ppm 8 ppm 72 ppm - 6 -
10 N
11 2.7 2 ppm cgmp 8 ppm - 8 -
12 NO cgmp ppm n=6 SD pmol/ml Plasma Min Max ppm n=6 SD pmol/ml Plasma Min Max NO MetHb RDR-76-DD MetHb 3) ppm NO 3 52 ppm NO MetHb 5% MetHb MetHb CTD 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): MetHb min ppm NO MetHb 2. min ppm MetHb Css MetHb NO MetHb 4 5 3) MetHb - 9 -
13 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 NOMetHb Ke T /2 C base K f min - min %MetHb NOMetHbMetHb NO Css MetHb ppm %MetHb %/min NO NO CTN-NO NO NO 25 ppm 6 NO NO ppm NO 2 MetHb NOHb µmol/l 2 5 in vitro % % 27 85%MetHb NOHb
14 2.7 NO NO 25 ppm 6 26 µmol/l 38 µmol/l P. MetHb.35%.64%P. NOHb 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 MetHb INO-/ PPHN 55 NO NO 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 NO MetHb 8 ppm MetHb 8 2 5% 2 ppm MetHb % - -
15 MetHb SE -INO-/2-8 ppm 2 ppm 5 ppm MetHb SD -INO-/2 - NO N 36 a SD N SD N SD N 39 b SD a 8 ppm 37 MetHb 36 b 4 MetHb 39 8 ppm % MetHb 7%8 ppm 37 MetHb 36 MetHb MetHb
16 MetHb ppm MetHb 7% 2. Methemoglobin Levels (%) 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_ Time (hours) ppm MetHb -INO-/ MetHb INOT NO 2 ppm 4 4 PaO 2 6 mmhg SpO 2 92% 5 ppm NO FiO PaO 2 7 mmhg 5 ppm MetHb NO MetHb 5% NO MetHb MetHb 2% 2 ppm NO MetHb 5% - 3 -
17 MetHb % Pt No / n.d Mean SD Min Max n.d. not done 2.7
18 MetHb (%) # # 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 MetHb % PPHN NO OI CTN:NO PPHN NO OI 5 4 cmh 2 O/mmHg ppm NO 5 SpO 2 85 NO OI NO ppm ppm OI cmh 2 O/mmHg cmh 2 O/mmHg SE cmh 2 O/mmHg cmh 2 O/mmHgSE
19 OI 5 4 cmh 2 O/mmHg PPHN NO OI SE OI 5 4 cmh 2 O/mmHg NO OI SE - 6 -
20 NO PPHN 79% 5% 25% OI OI 25% OI 3 ppm 3 ppm NO ICR NO 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 ACT aptt PT NO NO - 7 -
21
22 ppm 3 NO MetHb CTN:NO / NO/N 2 3% 2 4 ppm , ,469,54 4,52 2,45 8,472 3 NO / NO NO NO NO MetHb NO MetHb - 9 -
23 PPHN MetHb NO 2 ppm NO MetHb 52 ppm MetHb 5%28 ppm 5% RDR-76-DDPPHN 8 ppm % MetHb 7%INO-/2 MetHb MetHb 4 5 RDR-76-DD MetHb 7% INO-/2 MetHb 5) MetHb 2 8 ppm 5 NO 5 N- ICR 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 -
24 ICR 342 MetHb NO NO CTN:NO- -6 NO NO
25 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 / 4 4 / / 7 * 5 *: / / /8 2 6 / / 2 2 / MetHb MetHb %5% 3 6 ppm NO 5 NO 2 SD ppm 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 ±SD %+.5.26,.74 P. MetHb % P. 8 ppm MetHb % 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± ± 2.86 T max ( ).42±.2.42±.2 AUC - (µmol hr/l) 54.77± ± T /2 () 6.728± ±.958 CL/F (L/hr) 2.922± ±.32 NO NO MetHb 4 / NO 32, 64, 28, 52 Ke C base (min - K ) () (%MetHb) f 4 ppm * 3) MetHb T /
26 CINRGI INO-/2 INOT2 Ohmeda NO-3 NINOS INOSG 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 INO-/ ECMO
27 2.7 ECMO NO ECMO INOT 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 OI NINOS INOSG GCP Ohmeda NO-3 GCP CINRGI PPHN 96 N 2 () NO 2 ppm 4 24 PaO 2 6 mmhg ph ppm FiO PaO 2 6 mmhg FiO 2.8 NO
28 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) CINRGI CINRGI ECMO a/a P A O 2 A-aDO 2 PaO 2 OI ECMO ECMO ECMO ECMO INO-/ PPHN 72 N 2 NO PPHN ECMO NO () 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%
29 2.7 8 ppm NO 3 24 PPHN,7,8) 8 ppm 2 ppm 5 ppm (2) INO-/2 INO-/2. PPHN ECMO 28 MRI CAT Computer axial tomography 2. ECMO 3. PPHN 4. ECMO MAP ph PaO 2 PaCO 2 SpO 2 OI A-aDO 2 PEEP FiO 2 ECMO INOT () ) 2 ppm 4 PaO 2 6 mmhg SpO 2 92% 5 ppm 2) FiO 2 NO FiO PaO 2 7 mmhg 5 ppm 3) FiO 2. (2)
30 INOT2 INOT OI a/a PaO 2 /FiO 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 Ohmeda NO INO-/ ppm NO ppm NO 3 4 () 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)
31 Ohmeda NO-3 Ohmeda NO-3. ECMO 2. PPHN ECMO 28 MAP ph PaO 2 PaCO 2 SpO 2 OI A-aDO NINOS INOSG NINOS PPHN RDSMAS INOSG PPHN NINOS O 2 INOSG N 2 NO () 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 INOSG NO FiO ppm 2 OI 4 cmh 2 O/mmHg 4 mmhg PaO 2 55 mmhg PaO 2 5% PaO 2 55 mmhg 2 ppm
32 2.7 (2) 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 NO PPHN NO NO NO () PPHN ppm NO 8 ppm (2) NO NO NO OI PPHN CINRGI PPHN 22 4 NO 8 NO N 2 NO 2 ppm ppm 96 7 NO PPHN NO 97 ECMO
33 2.7 P /82 3.4%NO 3/92 3.3%P.2328 P ECMO ECMO -CINRGI - NO P ECMO ECMO 5/ % 38/ % 3/97 3.9% 67/97 69.%. Cochran-Mantel- Haenszel a/a SE-CINRGI
34 PaO2 in mm Hg a-a DO2 Gradient Placebo Inhaled NO Time in hours A-aDO 2 SE-CINRGI Placebo Inhaled NO Time PaO 2 SE-CINRGI
35 Oxygenation Index in cm H2O/ mm Hg Placebo 3 Inhaled NO Time in hours OI SE-CINRGI CINRGI - a P NO Fisher 28 5/88 5.7% 3/97 3.% /88 5.7% 4/97 4.%.738 a ECMO -CINRGI - ECMO 28 SD NO P 3/5 9/. 86.7% 8.8% Fisher 6/5 4/. 4.% 36.4% χ N 9 N 7 t PPHN INO-/ PPHN 37 NO ppm NO PPHN N
36 HFV ppm 4 2 ppm 36 8 ppm ppm 4 PPHN ECMO PPHN 56% 23/4 NO 5% 52/4 P NO OI NO 24 NO -.6 NO -5. P PaO 2 A-aDO 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
37 Pooled NO Placebo PaO2 (mm Hg) Time (hours) PaO 2 SE -INO-/ Placebo Pooled NO A-aDO2 mm HG Time (hours) A-aDO 2 SE -INO-/
38 a/a SE -INO-/ OI SE -INO-/
39 OI -INO-/2 - N 2 NO 5 ppm 2 ppm 8 ppm cmh 2 O/mmHg SD , , , , , 3.67 P Wilcoxon PaO 2 SE -INO-/
40 A-aDO 2 SE -INO-/ INOT OI SD cmh 2 O/mmHg cmh 2 O/mmHg cmh 2 O/mmHg
41 OI cmh 2 O/mmHg INOT2 CINRGI a INO-/2 a NINOS a a SD SD NA NA SD NA SD 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 a/a PaO 2 /FiO 2 NO NO a/a INOT2 CINRGI a INO-/2 a a SD SD NA SD SD INOT2 generalized linear model... P F NA a CINRGI NO INO-/2 5 ppm NO 34 INOT2 CINRGI NO 2 NO
42 PaO 2 /FiO 2 INOT2 CINRGI a INO-/2 a a INOT2 generalized linear model P F SD SD SD SD NA NA a CINRGI NO INO-/2 5 ppm NO 34 INOT2 CINRGI NO 2 NO PPHN Ohmeda NO PPHN ppm 4 4 PPHN NO INO-/ NINOS NINOS 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 PaO 2 OI A-aDO 2 NO P
43 Change in Oxygenation Index (cm H2O/torr) Change in PaO2 (torr) 2.7 ECMO ECMO ECMO NINOS - 2/2 7% 66/2 55% 77/2 64% NO 6/4 4% 44/4 39% 52/4 46% P χ Placebo Dose Group Inhaled NO PaO 2 SE -NINOS Placebo Inhaled NO Dose Group OI SE -NINOS
44 A-aDO 2 SE -NINOS - 2 ppm PaO 2 mmhg PaO 2 2 mmhg 8 ppm 75 75% NO % 8 ppm
45 NO 2 ppm NO 2 ppm NO 8 ppm NINOS - 2 ppm a NO 2 ppm b N 7 N 2 PaO 2 mmhg % % PaO 2 2 mmhg 3.% 7 5.2% PaO 2 2 mmhg 7 4.5% % 8 ppm NO 8 ppm NO 2 ppm N 87 N 38 PaO 2 mmhg % % 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% % 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 INOSG INOSG PPHN NO 3 PPHN NO 2 ECMO 7% 2/28 NO 53% 6/3 NO Cochran-Mantel-Haenszel χ 2 P PaO 2 OI NO Wilcoxon PaO 2 P. OI P. NO 2 OI 4 cmh 2 O/mmHg PaO 2 55 mmhg 4 mmhg
46 PaO 2 SE -INOSG - 5. Oxygenation Index (cm H2O/ mm Hg) Control Inhaled NO. Baseline 2 minutes Time Period OI SE -INOSG
47 2.7 ECMO 7% 2/28 NO 4% 2/3 NO Cochran-Mantel-Haenszel χ 2 P ECMO INOSG - NO ECMO 2/28 7% 2/3 4% ECMO 8/28 29% 8/3 6% Cochran-Mantel-Haenszel χ 2 P NO NO PPHN NO % NO NO 24 OI 2 cmh 2 O/mmHg 43 NO NO PPHN CINRGI INO-/2 Ohmeda NO-3 NINOS INOSG INOT PPHN INOT INO-/2 INOT2 Ohmeda NO-3 INO-/2 Ohmeda NO-3 NINOS INOSG CINRGI NO ECMO
48 CINRGI INO-/2 INOT2 PPHN OI 25 cmh 2 O/mmHg PPHN ,5 g 39 2, g 72 FiO 2. cmh 2 O PaO 2 4 mmhg SpO 2 % PPHN NO 68 FiO 2. PaO 2 8 mmhg i) ii) SpO 2 Ohmeda NO-3 PPHN ,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 PaO 2 55 mmhg PPHN 7 3 PaO 2 8 mmhg HFOV 2.7
49 CINRGI INO-/2 INOT2 ECMO ECMO 35 mmhg 7% HFOV 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
50 INO-/2 Ohmeda NO-3 PaO mmhg OI 2 45 cmh 2 O/mmHg CINRGI
51 CINRGI NO 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 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.± ±.8 4.2± ± ± ± ± ± ±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.± ±.5 PPHN MAS NA NA NA NA RDS NA NA NA NA ±SD 5.± ±2.6 5 ±SD 7.± ±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.± ±2.7 (N=2) 7.2±2.2 (N=9) 5.2±2.8 (N=3) 7.±2. (N=4) 3.7± ± ± ± ± ± ± ± ± ± ± ± ±8. 8.7± ± ± ±8. 42.±5.4 PaO 2 mmhg, ±SD 53.± ± ± ± ± ± ± ± ± ± ± ± ±9. 4.3±9.4 a NO 2 NO NA 2.7
52 NO CINRGI 26 CINRGI ECMO ECMO -CINRGI - ECMO 28 SD NO P 3/5 9/. 86.7% 8.8% Fisher 6/5 4/. 4.% 36.4% Fisher N 9 N 7 t
53 NO ECMO INO-/2 8 ppm 8 ppm %8 ppm 37 MetHb
54 - 5 - CINRGI NO INO-/2 NO 5 ppm 2 ppm 8 ppm INOT2 Ohmeda NO-3 5 ppm 2 ppm 8 ppm NINOS 2 b b a 48 a 23 a 9 a 7 a 27 a 3 2 a 6 a ECMO NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA 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 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 NA NA a bno 2 NO NA 2.7
55 () NO 8% 9% 2) NO (2) (3) OI () ECMO ECMO 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 ECMO
56 2.7 (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 (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
57 Change in Oxygenation Index (cm H2O/torr) Oxygenation Index in cm H2O/ mm Hg Placebo 3 Inhaled NO Time in hours OI SE-CINRGI Placebo Dose Group Inhaled NO OI SE -NINOS
58 PaO2 in mm Hg Oxygenation Index (cm H2O/ mm Hg) Control Inhaled NO. Baseline 2 minutes Time Period OI SE -INOSG - 2) PaO 2 PaO 2 NO PaO 2 NO CINRGI P. NINOS P. INOSG P Placebo Inhaled NO Time PaO 2 SE-CINRGI -
59 Change in PaO2 (torr) Placebo Dose Group Inhaled NO PaO 2 SE -NINOS 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
60 a-a DO2 Gradient Placebo Inhaled NO Time in hours A-aDO 2 SE-CINRGI A-aDO 2 SE -NINOS - a/a PaO 2 /FiO 2 NO INOT
61 INOT SD OI a/a PaO 2 /FiO NO CINRGI 26 CINRGI ECMO NO ECMO -CINRGI - ECMO 28 SD NO P 3/5 9/. 86.7% 8.8% Fisher 6/5 4/. 4.% 36.4% Fisher N 9 N 7 t- 2,5 g 29 NO Kinsella JP 9) 32 NO 48 NO P.3Schreiber ) NO
62 NO NOHb NO NOHb MetHb NO NO NO MetHb NO MetHb INO-/2 NO MetHb NO MetHb SE -INO-/
63 MetHb SD -INO-/2 - NO N 36 a ppm SD N ppm SD N ppm SD N 39 b SD a 8 ppm 37 MetHb 36 b 4 MetHb 39 INO-/2 5 ppm 8 ppm NO PaO 2 SE -INO-/
64 A-aDO 2 SE -INO-/2 - CINRGI 2 ppm 4 24 PaO 2 6 mmhg ph ppm FiO 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 -
65 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 %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 ppm 2,5 g 2,5 g ppm MetHb NO 2 2 ppm 4 2 ppm MetHb NO ppm CINRGI 5 ppm FiO 2.7 FiO 2.4 INOT2 CINRGI FiO PaO 2 7 mmhg 5 ppm CINRGI 5 ppm
66 2.7 CINRGI INO-/ NINOS 4 4 INOT2 7 4 NO NO SD CINRGI INO-/ ppm ppm NINOS a INOT a: NO CINRGI INO-/2 PPHN PPHN INO-/2 5ppm
67 CINRGI INO-/ SD NO 52/ / ppm 9/ ppm 2/ ppm 9/ / PPHN OI 25 cmh 2 O/mmHg PPHN ,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
68 INOT Ohmeda NO SD 4/ / ppm 4/ ppm 4/ ppm / NO 68 7 FiO 2. PaO 2 8 mmhg i) ii) SpO 2 PPHN ,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
69 NINOS INOSG SD NO PPHN RDS MAS 63/ / OI 25 cmh 2 O/mmHg 24 NO 6/ / 4..2 PPHN 37 2,5 g FiO 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
70 SD PPHN 7 3 PaO 2 8 mmhg HFOV OI / NO ppm 8 ppm 68/68 2.7
71 CINRGI ECMO 95% P OI PaO 2 A-aDO % 5/ , , , 57.7 NO 2 ppm 5 ppm % 3/97 P. a , , , 25. INO-/ % 4/ , , , 62. NO 5 ppm % /4 P.33 a NO 2 ppm % 9/36 P.38 a , , , NO 8 ppm % 6/37 P.7 a INOT2 NO 2 ppm 5 ppm NA NA SD: SD: Ohmeda NO-3 NO 5 ppm 4.% /4 7 NO 2 ppm 8 25.% 2/8 NA , , , NO 8 ppm 2 5.% /2 NINOS INOSG % 66/2 NA NA NA P.4 b NO 4 39% 44/4 NA NA NA 2 ppm % 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
72 CINRGI INO-/ Ohmeda NO INOT MetHb NO 2 INO-/ NINOS INOT2 CTN:NO CTN-NO ICR CINRGI INO-/ INO-/ INOT Ohmeda NO NINOS NINOS INOSG MetHb NO2 ECMO ECMO MetHb NO 2 MetHb NO 2 MetHb NO 2 MetHb NO 2 MetHb
73 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 ±
74 - 7 - CINRGI 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 b NO 2 ppm/ 8 ppm SD 26.2± ± ± ± ± ± ± ± ± ± ± ± INOSG 8 ppm 2 PaO 2 55 mmhg 2 NO ppm NO ano 2 NO b ppm 2.7
75 NO 2 ppm 25 ppm 4 ppm 8 ppm CTN:NO CTN-NO * ICR * CTN-NO- -8 NO MetHb 2 8 ppm NO INOT2 ITT CINRGI INOT2 34 NINOS 37 INO-/2 Ohmeda NO-3 INOSG PaO mmhg OI 2 45 cmh 2 O/mmHg
76 CINRGI NO 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 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.± ±.8 4.2± ± ± ± ± ± ±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.± ±.5 PPHN MAS NA NA NA NA RDS NA NA NA NA ±SD 5.± ±2.6 5 ±SD 7.± ±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.± ±.9 b 9.±. 7.±.9 6.± ±2.7 (N 2) 7.2±2.2 (N 9) 5.2±2.8 (N 3) 7.±2. (N 4) 3.7± ± ± ± ± ± ± ± ± ± ± ± ±8. 8.7± ± ± ±8. 42.±5.4 PaO 2 mmhg, ±SD 53.± ± ± ± ± ± ± ± ± ± ± ± ±9. 4.3±9.4 a CINRGI NO 2 NO b 2 3 NA 2.7
77 () ) NINOS INOSG MetHb CINRGI INO-/2 INOT2 Ohmeda NO
78 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 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
79 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 % 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
80 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 % 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
81 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 % % % % % % % % % 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
82 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 % 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
83 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 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
84 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 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
85 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 % 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
86 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 % 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
87 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 % 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
88 2.7 CINRGI INO-/2 Ohmeda NO-3 NINOS
89 CINRGI INO-/2 Ohmeda NO-3 NINOS 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
90 CINRGI INO-/2 Ohmeda NO-3 NINOS 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
91 CINRGI INO-/2 Ohmeda NO-3 NINOS 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
92 CINRGI INO-/2 Ohmeda NO-3 NINOS 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
93 CINRGI INO-/2 Ohmeda NO-3 NINOS 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
94 NO 5 ppm -CINRGI INO-/2 Ohmeda NO-3 NINOS 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
95 NO 2 ppm -CINRGI INO-/2 Ohmeda NO-3 NINOS 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
96 NO 2 ppm -CINRGI INO-/2 Ohmeda NO-3 NINOS 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
97 NO 2 ppm -CINRGI INO-/2 Ohmeda NO-3 NINOS 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
98 NO 2 ppm -CINRGI INO-/2 Ohmeda NO-3 NINOS 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
99 NO 8 ppm -CINRGI INO-/2 Ohmeda NO-3 NINOS 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
100 NO 8 ppm -CINRGI INO-/2 Ohmeda NO-3 NINOS NO 8 ppm N 39 N 2 N 3 N N 9 N 8 N 3 N N % 3% 3% 8% % % 2.7
101 2.7 2) INO-/2 NINOS a) INO-/2 INO-/ NO P INO-/2 - NO 5 ppm 2 ppm 8 ppm %.%.% 3.8%.3% 7.3% SD Fisher NO P=.9 NO NO Fisher P=
102 INO-/2 - NO 5 ppm 2 ppm 8 ppm cm SD P a kg SD P a cm SD P a a t INO-/2 - NO 5 ppm 2 ppm 8 ppm % 77.8% 86.% 69.% 74.2% 77.% % 8.3% 2.8% 6.9% 3.2% 4.2% %.% 8.3% 7.2% 6.% 3.5% % 2.8% 2.8% 6.9% 6.5% 5.2% P a a Cochran-Mantel-Haenszel χ
103 INO-/2 - NO 5 ppm 2 ppm 8 ppm % 9.7% 97.2% 82.8% 83.9% 88.5% % 5.6%.% 3.8% 9.7% 7.3% 2 4 % 2.8% 2.8% 3.4% 6.5% 4.2% P a a Cochran-Mantel-Haenszel χ 2 Bayley 2 The Psychological Corporation San AntonioBayley Bayley BSID-2 Mental Development Index, MDIMDI 5 85 MDI 5 7 MDI 855 MDI 7 MDI Bayley -INO-/2 - NO MDI 5 ppm 2 ppm 8 ppm % 5.6% 5.6% 3.4% 6.5% 5.2% % 6.% 58.3% 58.6% 54.8% 57.3% % 9.4% 6.7% 6.9% 6.% 3.5% % 2.8% 5.6%.3% 6.5% 7.3% % 5.6% 2.8% 3.8% 6.5% 7.3% % 5.6%.% 6.9% 9.7% 9.4% P a a Cochran-Mantel-Haenszel χ 2 Psychomotor Development Index, PDIPDI 5 85 PDI 5 7 PDI 855 PDI 7 PDI
104 Bayley -INO-/2 - NO PDI 5 ppm 2 ppm 8 ppm % 8.3%.% 3.4% 6.5% 7.3% % 66.7% 58.3% 55.2% 66.7% 6.4% %.% 5.6%.3% 3.2% 6.3% %.% 8.3% 6.9% 3.2% 6.3% % 5.6% 5.6% 3.8% 9.7% 9.4% % 8.3%.%.3% 9.7%.4% P a a Cochran-Mantel-Haenszel χ INO-/2 - NO 5 ppm 2 ppm 8 ppm % 63.9% 63.9% 65.5% 58.% 62.5% % 9.4% 5.6% 3.8% 2.9%.4% 2 %.% 2.8%.% 3.2% 2.% % 6.7% 27.8% 2.7% 25.8% 25.% P a a Cochran-Mantel-Haenszel χ 2 BSID-2 PDI MDI 25 db.5 2 khz BSID-2 PDI 85 MDI db.5 2 khz BSID-2 PDI 7 85 MDI db.5 2 khz BSID-2 PDI 7 MDI 7 - -
105 % NO 54.2% INO-/2 - NO 5 ppm 2 ppm 8 ppm % 5.% 63.9% 48.3% 48.4% 54.2% % 33.3% 6.7% 2.7% 22.6% 9.8% % 3.9% 9.4% 27.6% 22.6% 22.9% 2 3 % 2.8%.% 3.4% 6.5% 3.% P a a Cochran-Mantel-Haenszel χ 2 b) NINOS 2 NINOS NINOS NINOS - NO kgsd cmsd cmsd head control
106 NINOS - N 87 NO N % 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% % NO 6 7.% NINOS - N 87 NO N 84 9 %.3%.9% 2 4 % 2.3% 4.8% 2 % 2.3%.2% 5 5 % 5.7% 6.% % %NO 4 4.7%NO Fisher P.39 8% NO %
107 NINOS - N 82 NO N % 72.% 68.% 2 % 4.6% 3.3% 2 4 % 2.4% 5.3% 9 %.% 3.3% Bayley 2 MDISD NO PDISD NO SD % MDI PDI MDI -NINOS - N 73 NO N 77 SD MDI % 6.8% 7.8% MDI % 2.3% 9.5% MDI % 6.4%.7% MDI % 39.7% 27.3% MDI 8 26 % 24.7% 33.8% PDI -NINOS - N 75 NO N 78 SD PDI % 4.%.5% PDI % 8.%.3% PDI % 5.3% 5.4% PDI % 36.% 32.% PDI % 46.7% 3.8% - 4 -
108 2.7 (2) NO CINRGI INO-/2 INOT2 Ohmeda NO-3 5% NO 5% 49/24939/2492/2492/2499/249 8/249 6/2496/2495/249 NO - 5 -
109 % 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
110 % 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
111 % 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
112 % 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% % 9% 8 8% 9 8% % 3 3% 2% % 7% 7 7% % 9% ano 2 NO 2.7
113 CINRGI INO-/2 INOT2 Ohmeda NO 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 % ppm 5% MetHb INO-/2 8 ppm 7% MetHb %8 ppm 37 MetHb MetHb SE - INO-/
114 MetHb SD -INO-/2 - NO N 36 a ppm SD N ppm SD N ppm SD N 39 b SD a 8 ppm 37 MetHb 36 b 4 MetHb 39 INO-/2 7% MetHb MetHb SD 8 7% ppm 7% MetHb CINRGI MetHb NO MetHb NO MetHb P..5 Methemoglobin Levels in Percent Inhaled NO Placebo Hours MetHb SE -CINRGI - - -
115 2.7 INOT2 MetHb 2% MetHb MetHb (%) # # 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 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 CINRGI INO-/2 Ohmeda NO NO 2/43 8% 8/224 8% NO CINRGI -3 INO-/2 CINRGI INO-/ INOT2 NO ECMO NO - 2 -
116 CINRGI INO-/2 a N 44 c NO N % 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
117 CINRGI 3. kg ( ) (5 ) kg ( ) (5 ) ECMO 9 ECMO kg ( ) (5 ) ECMO kg ( ) 7 (5 ) ECMO ECMO 9 4 ECMO NO
118 CINRGI 5 3. kg ( ) 7 (5 ) 9 B 9 5 ECMO ECMO ECMO 5 ECMO NO 3.8 kg ( ) 5 (5 ) 9 9 NO 8 ECMO ECMO 9 7 NO 3.4 kg ( ) 5 (5 ) 9 9 NO HFOV NO 2.6 kg B ( ) 7 (5 ) 7 B 9 2 NO
119 CINRGI 9 NO kg ( ) 6 (5 ) 8 9 ECMO ECMO ECMO 9 22 ECMO kg B ( )4 (5 ) 6( )6 5 3 ECMO 9 3 ECMO kg ( ) 6 (5 ) kg ( ) (5 ) ECMO
120 CINRGI kg ( ) 2 (5 ) 5 9 ECMO 2 ECMO ECMO 9 9 ECMO kg ( ) (5 ) 3 3 ECMO ECMO NO NO kg ( ) 3 (5 ) ECMO ECMO ECMO
121 CINRGI 6 NO 7 NO 8 NO 9 NO 2.7 kg ( ) (5 ) 5 9 NO 2 ECMO 9 4 ECMO kg ( ) 7 (5 ) 8 9 NO ECMO ECMO kg ( ) (5 ) 4 7 NO 3 ECMO ECMO ECMO kg ( ) 5 (5 ) 6 9 NO 3 ECMO 9 ECMO
122 INO-/2 (INO-2) 2 (INO-2) 3 NO 5 ppm (INO-) 3.kg SIDS 2.9kg ( ) () XXXXY kg ( )7 (5 )9 9 2 (5 ppm)
123 INO-/2 4 NO 5 ppm (INO-) 5 NO 2 ppm (INO-) 6 NO 2 ppm (INO-) 4.5kg ( )4 (5 )7 9 (5 ppm) ECMO 3.7kg ( ) 8 (5 )9 3 9 (2 ppm) 5 6 mm Hg B kg ( ) (5 ) 9 5 (2 ppm) 9 56 NO
124 INO-/2 7 NO 2 ppm (INO-) 8 NO 2 ppm (INO-) 4.kg ( ) 8 (5 ) (2 ppm) meq/l ( ) kg ( ) (5 ) 9 ( 2 ppm) 9( 56 ) - 2 -
125 INO-/2 9 NO 2 ppm (INO-) NO 8 ppm (INO-) 2.6kg ( ) 4 (5 ) 9 9 (2 ppm) 2 ph NO kg ( ) 8 (5 )9 3 9 (8 ppm) PaO 2 33 (ECMO) ECMO NO ECMO 5 NO
126 INO-/2 NO 8 ppm (INO-) 2 NO 8 ppm (INO-) 4.kg ( ) (5 ) 6 9 (8 ppm) 7% 32 ppm( 4%) (ECMO) kg ( ) 8 (5 )9 9 (8 ppm)
127 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_
128 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 CINRGI INO-/2 INOT2 Ohmeda NO /
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