AustralieFrV1, PascalFrancis, Corpus, bibRecord, 001919

Inhaled Nitric Oxide in Preterm Infants: An Individual-Patient Data Meta-analysis of Randomized Trials

Identifieur interne : 001919 ( PascalFrancis/Corpus ); précédent : 001918; suivant : 001920

Inhaled Nitric Oxide in Preterm Infants: An Individual-Patient Data Meta-analysis of Randomized Trials

Auteurs : Lisa M. Askie ; Roberta A. Ballard ; Gary R. Cutter ; Carlo Dani ; Diana Elbourne ; David Field ; Jean-Michel Hascoet ; Anna Maria Hibbs ; John P. Kinsella ; Jean-Christophe Mercier ; Wade Rich ; Michael D. Schreiber ; Pimol Srisuparp Wongsiridej ; Nim V. Subhedar ; Krisa P. Van Meurs ; Merryn Voysey ; Keith Barrington ; Richard A. Ehrenkranz ; Neil N. Finer

Source :

Pediatrics : (Evanston) [ 0031-4005 ] ; 2011.

RBID : Pascal:11-0444160

Descripteurs français

Pascal (Inist)
- Maladie chronique, Monoxyde d'azote, Inhalation, Prématurité, Nourrisson, Prématuré, Pathologie du nouveau né, Donnée médicale, Métaanalyse, Article synthèse, Médecine factuelle, Essai clinique, Randomisation, Chronique, Pathologie des poumons, Pathologie de l'appareil respiratoire, Pédiatrie.

English descriptors

KwdEn :
- Chronic, Chronic disease, Clinical trial, Evidence-based medicine, Infant, Inhalation, Lung disease, Medical data, Metaanalysis, Newborn diseases, Nitric oxide, Pediatrics, Premature, Prematurity, Randomization, Respiratory disease, Review.

Abstract

BACKGROUND: Inhaled nitric oxide (iNO) is an effective therapy for pulmonary hypertension and hypoxic respiratory failure in term infants. Fourteen randomized controlled trials (n = 3430 infants) have been conducted on preterm infants at risk for chronic lung disease (CLD). The study results seem contradictory. DESIGN/METHODS: Individual-patient data meta-analysis included randomized controlled trials of preterm infants (<37 weeks' gestation). Outcomes were adjusted for trial differences and correlation between siblings. RESULTS: Data from 3298 infants in 12 trials (96%) were analyzed. There was no statistically significant effect of iNO on death or CLD (59% vs 61%: relative risk [RR]: 0.96 [95% confidence interval (CI): 0.92-1.01]; P = .11) or severe neurologic events on imaging (25% vs 23%: RR: 1.12 [95% CI: 0.98-1.28]; P = .09). There were no statistically significant differences in iNO effect according to any of the patient-level characteristics tested. In trials that used a starting iNO dose of >5 vs ≤5 ppm there was evidence of improved outcome (interaction P = .02); however, these differences were not observed at other levels of exposure to iNO. This result was driven primarily by 1 trial, which also differed according to overall dose, duration, timing, and indication for treatment ; a significant reduction in death or CLD (RR: 0.85 [95% CI: 0.74- 0.98]) was found. CONCLUSIONS: Routine use of iNO for treatment of respiratory failure in preterm infants cannot be recommended. The use of a higher starting dose might be associated with improved outcome, but because there were differences in the designs of these trials, it requires further examination.

Notice en format standard (ISO 2709)

Pour connaître la documentation sur le format Inist Standard.

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C01	`01`		`ENG`	@0 BACKGROUND: Inhaled nitric oxide (iNO) is an effective therapy for pulmonary hypertension and hypoxic respiratory failure in term infants. Fourteen randomized controlled trials (n = 3430 infants) have been conducted on preterm infants at risk for chronic lung disease (CLD). The study results seem contradictory. DESIGN/METHODS: Individual-patient data meta-analysis included randomized controlled trials of preterm infants (<37 weeks' gestation). Outcomes were adjusted for trial differences and correlation between siblings. RESULTS: Data from 3298 infants in 12 trials (96%) were analyzed. There was no statistically significant effect of iNO on death or CLD (59% vs 61%: relative risk [RR]: 0.96 [95% confidence interval (CI): 0.92-1.01]; P = .11) or severe neurologic events on imaging (25% vs 23%: RR: 1.12 [95% CI: 0.98-1.28]; P = .09). There were no statistically significant differences in iNO effect according to any of the patient-level characteristics tested. In trials that used a starting iNO dose of >5 vs ≤5 ppm there was evidence of improved outcome (interaction P = .02); however, these differences were not observed at other levels of exposure to iNO. This result was driven primarily by 1 trial, which also differed according to overall dose, duration, timing, and indication for treatment ; a significant reduction in death or CLD (RR: 0.85 [95% CI: 0.74- 0.98]) was found. CONCLUSIONS: Routine use of iNO for treatment of respiratory failure in preterm infants cannot be recommended. The use of a higher starting dose might be associated with improved outcome, but because there were differences in the designs of these trials, it requires further examination.
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Format Inist (serveur)

NO :	PASCAL 11-0444160 INIST
ET :	Inhaled Nitric Oxide in Preterm Infants: An Individual-Patient Data Meta-analysis of Randomized Trials
AU :	ASKIE (Lisa M.); BALLARD (Roberta A.); CUTTER (Gary R.); DANI (Carlo); ELBOURNE (Diana); FIELD (David); HASCOET (Jean-Michel); HIBBS (Anna Maria); KINSELLA (John P.); MERCIER (Jean-Christophe); RICH (Wade); SCHREIBER (Michael D.); WONGSIRIDEJ (Pimol (srisuparp)); SUBHEDAR (Nim V.); VAN MEURS (Krisa P.); VOYSEY (Merryn); BARRINGTON (Keith); EHRENKRANZ (Richard A.); FINER (Neil N.)
AF :	National Health and Medical Research Council Clinical Trials Centre, University of Sydney/Sydney/Australie (1 aut., 16 aut.); Department of Pediatrics, University of California at San Francisco, School of Medicine/San Francisco, California/Etats-Unis (2 aut.); School of Public Health, University of Alabama at Birmingham/Birmingham, Alabama/Etats-Unis (3 aut.); Section of Neonatology, Department of Surgical and Medical Critical Care, Careggi University Hospital of Florence/Florence/Italie (4 aut.); Department of Medical Statistics, London School of Hygiene and Tropical Medicine/London/Royaume-Uni (5 aut.); Department of Health Science, University of Leicester/Leicester/Royaume-Uni (6 aut.); Neonatology, Maternite Regionale Universitaire/Nancy/France (7 aut.); Department of Pediatrics, Case Western Reserve University and Rainbow Babies & Children's Hospital/Cleveland, Ohio/Etats-Unis (8 aut.); Department of Pediatrics, University of Colorado School of Medicine/Denver, Colorado/Etats-Unis (9 aut.); Department of Pediatric Emergency Medicine, Hôpital Robert Debré, Université Paris-7 Denis Diderot/Paris/France (10 aut.); Division of Neonatology, University of California/San Diego, California/Etats-Unis (11 aut., 19 aut.); Department of Pediatrics, University of Chicago/Chicago, Illinois/Etats-Unis (12 aut.); Division of Neonatology, Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University/Bangkok/Thaïlande (13 aut.); Neonatal Unit, Liverpool Women's Hospital/Liverpool/Royaume-Uni (14 aut.); Divisian of Neonatal and Developmental Medicine, Stanford University School of Medicine and Lucile Salter Packard Children's Hospital/Palo Alto, California/Etats-Unis (15 aut.); Division of Neonatology, Centre Hospitalier Universitaire Ste-Justine, Montreal/Quebec/Canada (17 aut.); Department of Pediatrics, Yale University School of Medicine/New Haven, Connecticut/Etats-Unis (18 aut.)
DT :	Publication en série; Niveau analytique
SO :	Pediatrics : (Evanston); ISSN 0031-4005; Coden PEDIAU; Etats-Unis; Da. 2011; Vol. 128; No. 4; Pp. 729-739; Bibl. 44 ref.
LA :	Anglais
EA :	BACKGROUND: Inhaled nitric oxide (iNO) is an effective therapy for pulmonary hypertension and hypoxic respiratory failure in term infants. Fourteen randomized controlled trials (n = 3430 infants) have been conducted on preterm infants at risk for chronic lung disease (CLD). The study results seem contradictory. DESIGN/METHODS: Individual-patient data meta-analysis included randomized controlled trials of preterm infants (<37 weeks' gestation). Outcomes were adjusted for trial differences and correlation between siblings. RESULTS: Data from 3298 infants in 12 trials (96%) were analyzed. There was no statistically significant effect of iNO on death or CLD (59% vs 61%: relative risk [RR]: 0.96 [95% confidence interval (CI): 0.92-1.01]; P = .11) or severe neurologic events on imaging (25% vs 23%: RR: 1.12 [95% CI: 0.98-1.28]; P = .09). There were no statistically significant differences in iNO effect according to any of the patient-level characteristics tested. In trials that used a starting iNO dose of >5 vs ≤5 ppm there was evidence of improved outcome (interaction P = .02); however, these differences were not observed at other levels of exposure to iNO. This result was driven primarily by 1 trial, which also differed according to overall dose, duration, timing, and indication for treatment ; a significant reduction in death or CLD (RR: 0.85 [95% CI: 0.74- 0.98]) was found. CONCLUSIONS: Routine use of iNO for treatment of respiratory failure in preterm infants cannot be recommended. The use of a higher starting dose might be associated with improved outcome, but because there were differences in the designs of these trials, it requires further examination.
CC :	002B01; 002B30A11
FD :	Maladie chronique; Monoxyde d'azote; Inhalation; Prématurité; Nourrisson; Prématuré; Pathologie du nouveau né; Donnée médicale; Métaanalyse; Article synthèse; Médecine factuelle; Essai clinique; Randomisation; Chronique; Pathologie des poumons; Pathologie de l'appareil respiratoire; Pédiatrie
FG :	Homme; Pratique basée sur des preuves
ED :	Chronic disease; Nitric oxide; Inhalation; Prematurity; Infant; Premature; Newborn diseases; Medical data; Metaanalysis; Review; Evidence-based medicine; Clinical trial; Randomization; Chronic; Lung disease; Respiratory disease; Pediatrics
EG :	Human; Evidence-based practice
SD :	Enfermedad crónica; Nitrógeno monóxido; Inhalación; Prematuridad; Lactante; Prematuro; Recién nacido patología; Datos Médicos; Meta-análisis; Artículo síntesis; Medicina basada en pruebas; Ensayo clínico; Aleatorización; Crónico; Pulmón patología; Aparato respiratorio patología; Pediatría
LO :	INIST-6967.354000507806350150
ID :	11-0444160

Links to Exploration step

Pascal:11-0444160

Le document en format XML

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<author><name sortKey="Rich, Wade" sort="Rich, Wade" uniqKey="Rich W" first="Wade" last="Rich">Wade Rich</name>
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<author><name sortKey="Schreiber, Michael D" sort="Schreiber, Michael D" uniqKey="Schreiber M" first="Michael D." last="Schreiber">Michael D. Schreiber</name>
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<affiliation><inist:fA14 i1="14"><s1>Neonatal Unit, Liverpool Women's Hospital</s1>
<s2>Liverpool</s2>
<s3>GBR</s3>
<sZ>14 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Van Meurs, Krisa P" sort="Van Meurs, Krisa P" uniqKey="Van Meurs K" first="Krisa P." last="Van Meurs">Krisa P. Van Meurs</name>
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<s2>Palo Alto, California</s2>
<s3>USA</s3>
<sZ>15 aut.</sZ>
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<s2>Sydney</s2>
<s3>AUS</s3>
<sZ>1 aut.</sZ>
<sZ>16 aut.</sZ>
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<s2>Quebec</s2>
<s3>CAN</s3>
<sZ>17 aut.</sZ>
</inist:fA14>
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</author>
<author><name sortKey="Ehrenkranz, Richard A" sort="Ehrenkranz, Richard A" uniqKey="Ehrenkranz R" first="Richard A." last="Ehrenkranz">Richard A. Ehrenkranz</name>
<affiliation><inist:fA14 i1="17"><s1>Department of Pediatrics, Yale University School of Medicine</s1>
<s2>New Haven, Connecticut</s2>
<s3>USA</s3>
<sZ>18 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Finer, Neil N" sort="Finer, Neil N" uniqKey="Finer N" first="Neil N." last="Finer">Neil N. Finer</name>
<affiliation><inist:fA14 i1="11"><s1>Division of Neonatology, University of California</s1>
<s2>San Diego, California</s2>
<s3>USA</s3>
<sZ>11 aut.</sZ>
<sZ>19 aut.</sZ>
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<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Inhaled Nitric Oxide in Preterm Infants: An Individual-Patient Data Meta-analysis of Randomized Trials</title>
<author><name sortKey="Askie, Lisa M" sort="Askie, Lisa M" uniqKey="Askie L" first="Lisa M." last="Askie">Lisa M. Askie</name>
<affiliation><inist:fA14 i1="01"><s1>National Health and Medical Research Council Clinical Trials Centre, University of Sydney</s1>
<s2>Sydney</s2>
<s3>AUS</s3>
<sZ>1 aut.</sZ>
<sZ>16 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Ballard, Roberta A" sort="Ballard, Roberta A" uniqKey="Ballard R" first="Roberta A." last="Ballard">Roberta A. Ballard</name>
<affiliation><inist:fA14 i1="02"><s1>Department of Pediatrics, University of California at San Francisco, School of Medicine</s1>
<s2>San Francisco, California</s2>
<s3>USA</s3>
<sZ>2 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Cutter, Gary R" sort="Cutter, Gary R" uniqKey="Cutter G" first="Gary R." last="Cutter">Gary R. Cutter</name>
<affiliation><inist:fA14 i1="03"><s1>School of Public Health, University of Alabama at Birmingham</s1>
<s2>Birmingham, Alabama</s2>
<s3>USA</s3>
<sZ>3 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Dani, Carlo" sort="Dani, Carlo" uniqKey="Dani C" first="Carlo" last="Dani">Carlo Dani</name>
<affiliation><inist:fA14 i1="04"><s1>Section of Neonatology, Department of Surgical and Medical Critical Care, Careggi University Hospital of Florence</s1>
<s2>Florence</s2>
<s3>ITA</s3>
<sZ>4 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Elbourne, Diana" sort="Elbourne, Diana" uniqKey="Elbourne D" first="Diana" last="Elbourne">Diana Elbourne</name>
<affiliation><inist:fA14 i1="05"><s1>Department of Medical Statistics, London School of Hygiene and Tropical Medicine</s1>
<s2>London</s2>
<s3>GBR</s3>
<sZ>5 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Field, David" sort="Field, David" uniqKey="Field D" first="David" last="Field">David Field</name>
<affiliation><inist:fA14 i1="06"><s1>Department of Health Science, University of Leicester</s1>
<s2>Leicester</s2>
<s3>GBR</s3>
<sZ>6 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Hascoet, Jean Michel" sort="Hascoet, Jean Michel" uniqKey="Hascoet J" first="Jean-Michel" last="Hascoet">Jean-Michel Hascoet</name>
<affiliation><inist:fA14 i1="07"><s1>Neonatology, Maternite Regionale Universitaire</s1>
<s2>Nancy</s2>
<s3>FRA</s3>
<sZ>7 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Hibbs, Anna Maria" sort="Hibbs, Anna Maria" uniqKey="Hibbs A" first="Anna Maria" last="Hibbs">Anna Maria Hibbs</name>
<affiliation><inist:fA14 i1="08"><s1>Department of Pediatrics, Case Western Reserve University and Rainbow Babies & Children's Hospital</s1>
<s2>Cleveland, Ohio</s2>
<s3>USA</s3>
<sZ>8 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Kinsella, John P" sort="Kinsella, John P" uniqKey="Kinsella J" first="John P." last="Kinsella">John P. Kinsella</name>
<affiliation><inist:fA14 i1="09"><s1>Department of Pediatrics, University of Colorado School of Medicine</s1>
<s2>Denver, Colorado</s2>
<s3>USA</s3>
<sZ>9 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Mercier, Jean Christophe" sort="Mercier, Jean Christophe" uniqKey="Mercier J" first="Jean-Christophe" last="Mercier">Jean-Christophe Mercier</name>
<affiliation><inist:fA14 i1="10"><s1>Department of Pediatric Emergency Medicine, Hôpital Robert Debré, Université Paris-7 Denis Diderot</s1>
<s2>Paris</s2>
<s3>FRA</s3>
<sZ>10 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Rich, Wade" sort="Rich, Wade" uniqKey="Rich W" first="Wade" last="Rich">Wade Rich</name>
<affiliation><inist:fA14 i1="11"><s1>Division of Neonatology, University of California</s1>
<s2>San Diego, California</s2>
<s3>USA</s3>
<sZ>11 aut.</sZ>
<sZ>19 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Schreiber, Michael D" sort="Schreiber, Michael D" uniqKey="Schreiber M" first="Michael D." last="Schreiber">Michael D. Schreiber</name>
<affiliation><inist:fA14 i1="12"><s1>Department of Pediatrics, University of Chicago</s1>
<s2>Chicago, Illinois</s2>
<s3>USA</s3>
<sZ>12 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Wongsiridej, Pimol Srisuparp" sort="Wongsiridej, Pimol Srisuparp" uniqKey="Wongsiridej P" first="Pimol Srisuparp" last="Wongsiridej">Pimol Srisuparp Wongsiridej</name>
<affiliation><inist:fA14 i1="13"><s1>Division of Neonatology, Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University</s1>
<s2>Bangkok</s2>
<s3>THA</s3>
<sZ>13 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Subhedar, Nim V" sort="Subhedar, Nim V" uniqKey="Subhedar N" first="Nim V." last="Subhedar">Nim V. Subhedar</name>
<affiliation><inist:fA14 i1="14"><s1>Neonatal Unit, Liverpool Women's Hospital</s1>
<s2>Liverpool</s2>
<s3>GBR</s3>
<sZ>14 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Van Meurs, Krisa P" sort="Van Meurs, Krisa P" uniqKey="Van Meurs K" first="Krisa P." last="Van Meurs">Krisa P. Van Meurs</name>
<affiliation><inist:fA14 i1="15"><s1>Divisian of Neonatal and Developmental Medicine, Stanford University School of Medicine and Lucile Salter Packard Children's Hospital</s1>
<s2>Palo Alto, California</s2>
<s3>USA</s3>
<sZ>15 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Voysey, Merryn" sort="Voysey, Merryn" uniqKey="Voysey M" first="Merryn" last="Voysey">Merryn Voysey</name>
<affiliation><inist:fA14 i1="01"><s1>National Health and Medical Research Council Clinical Trials Centre, University of Sydney</s1>
<s2>Sydney</s2>
<s3>AUS</s3>
<sZ>1 aut.</sZ>
<sZ>16 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Barrington, Keith" sort="Barrington, Keith" uniqKey="Barrington K" first="Keith" last="Barrington">Keith Barrington</name>
<affiliation><inist:fA14 i1="16"><s1>Division of Neonatology, Centre Hospitalier Universitaire Ste-Justine, Montreal</s1>
<s2>Quebec</s2>
<s3>CAN</s3>
<sZ>17 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Ehrenkranz, Richard A" sort="Ehrenkranz, Richard A" uniqKey="Ehrenkranz R" first="Richard A." last="Ehrenkranz">Richard A. Ehrenkranz</name>
<affiliation><inist:fA14 i1="17"><s1>Department of Pediatrics, Yale University School of Medicine</s1>
<s2>New Haven, Connecticut</s2>
<s3>USA</s3>
<sZ>18 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Finer, Neil N" sort="Finer, Neil N" uniqKey="Finer N" first="Neil N." last="Finer">Neil N. Finer</name>
<affiliation><inist:fA14 i1="11"><s1>Division of Neonatology, University of California</s1>
<s2>San Diego, California</s2>
<s3>USA</s3>
<sZ>11 aut.</sZ>
<sZ>19 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
</analytic>
<series><title level="j" type="main">Pediatrics : (Evanston)</title>
<title level="j" type="abbreviated">Pediatrics : (Evanston)</title>
<idno type="ISSN">0031-4005</idno>
<imprint><date when="2011">2011</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
<seriesStmt><title level="j" type="main">Pediatrics : (Evanston)</title>
<title level="j" type="abbreviated">Pediatrics : (Evanston)</title>
<idno type="ISSN">0031-4005</idno>
</seriesStmt>
</fileDesc>
<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Chronic</term>
<term>Chronic disease</term>
<term>Clinical trial</term>
<term>Evidence-based medicine</term>
<term>Infant</term>
<term>Inhalation</term>
<term>Lung disease</term>
<term>Medical data</term>
<term>Metaanalysis</term>
<term>Newborn diseases</term>
<term>Nitric oxide</term>
<term>Pediatrics</term>
<term>Premature</term>
<term>Prematurity</term>
<term>Randomization</term>
<term>Respiratory disease</term>
<term>Review</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr"><term>Maladie chronique</term>
<term>Monoxyde d'azote</term>
<term>Inhalation</term>
<term>Prématurité</term>
<term>Nourrisson</term>
<term>Prématuré</term>
<term>Pathologie du nouveau né</term>
<term>Donnée médicale</term>
<term>Métaanalyse</term>
<term>Article synthèse</term>
<term>Médecine factuelle</term>
<term>Essai clinique</term>
<term>Randomisation</term>
<term>Chronique</term>
<term>Pathologie des poumons</term>
<term>Pathologie de l'appareil respiratoire</term>
<term>Pédiatrie</term>
</keywords>
</textClass>
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<front><div type="abstract" xml:lang="en">BACKGROUND: Inhaled nitric oxide (iNO) is an effective therapy for pulmonary hypertension and hypoxic respiratory failure in term infants. Fourteen randomized controlled trials (n = 3430 infants) have been conducted on preterm infants at risk for chronic lung disease (CLD). The study results seem contradictory. DESIGN/METHODS: Individual-patient data meta-analysis included randomized controlled trials of preterm infants (<37 weeks' gestation). Outcomes were adjusted for trial differences and correlation between siblings. RESULTS: Data from 3298 infants in 12 trials (96%) were analyzed. There was no statistically significant effect of iNO on death or CLD (59% vs 61%: relative risk [RR]: 0.96 [95% confidence interval (CI): 0.92-1.01]; P = .11) or severe neurologic events on imaging (25% vs 23%: RR: 1.12 [95% CI: 0.98-1.28]; P = .09). There were no statistically significant differences in iNO effect according to any of the patient-level characteristics tested. In trials that used a starting iNO dose of >5 vs ≤5 ppm there was evidence of improved outcome (interaction P = .02); however, these differences were not observed at other levels of exposure to iNO. This result was driven primarily by 1 trial, which also differed according to overall dose, duration, timing, and indication for treatment ; a significant reduction in death or CLD (RR: 0.85 [95% CI: 0.74- 0.98]) was found. CONCLUSIONS: Routine use of iNO for treatment of respiratory failure in preterm infants cannot be recommended. The use of a higher starting dose might be associated with improved outcome, but because there were differences in the designs of these trials, it requires further examination.</div>
</front>
</TEI>
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<fA08 i1="01" i2="1" l="ENG"><s1>Inhaled Nitric Oxide in Preterm Infants: An Individual-Patient Data Meta-analysis of Randomized Trials</s1>
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<fA11 i1="01" i2="1"><s1>ASKIE (Lisa M.)</s1>
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<fA11 i1="02" i2="1"><s1>BALLARD (Roberta A.)</s1>
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<fA11 i1="11" i2="1"><s1>RICH (Wade)</s1>
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<fA11 i1="12" i2="1"><s1>SCHREIBER (Michael D.)</s1>
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<fA11 i1="13" i2="1"><s1>WONGSIRIDEJ (Pimol (srisuparp))</s1>
</fA11>
<fA11 i1="14" i2="1"><s1>SUBHEDAR (Nim V.)</s1>
</fA11>
<fA11 i1="15" i2="1"><s1>VAN MEURS (Krisa P.)</s1>
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<fA11 i1="16" i2="1"><s1>VOYSEY (Merryn)</s1>
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<fA11 i1="17" i2="1"><s1>BARRINGTON (Keith)</s1>
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<fA11 i1="18" i2="1"><s1>EHRENKRANZ (Richard A.)</s1>
</fA11>
<fA11 i1="19" i2="1"><s1>FINER (Neil N.)</s1>
</fA11>
<fA14 i1="01"><s1>National Health and Medical Research Council Clinical Trials Centre, University of Sydney</s1>
<s2>Sydney</s2>
<s3>AUS</s3>
<sZ>1 aut.</sZ>
<sZ>16 aut.</sZ>
</fA14>
<fA14 i1="02"><s1>Department of Pediatrics, University of California at San Francisco, School of Medicine</s1>
<s2>San Francisco, California</s2>
<s3>USA</s3>
<sZ>2 aut.</sZ>
</fA14>
<fA14 i1="03"><s1>School of Public Health, University of Alabama at Birmingham</s1>
<s2>Birmingham, Alabama</s2>
<s3>USA</s3>
<sZ>3 aut.</sZ>
</fA14>
<fA14 i1="04"><s1>Section of Neonatology, Department of Surgical and Medical Critical Care, Careggi University Hospital of Florence</s1>
<s2>Florence</s2>
<s3>ITA</s3>
<sZ>4 aut.</sZ>
</fA14>
<fA14 i1="05"><s1>Department of Medical Statistics, London School of Hygiene and Tropical Medicine</s1>
<s2>London</s2>
<s3>GBR</s3>
<sZ>5 aut.</sZ>
</fA14>
<fA14 i1="06"><s1>Department of Health Science, University of Leicester</s1>
<s2>Leicester</s2>
<s3>GBR</s3>
<sZ>6 aut.</sZ>
</fA14>
<fA14 i1="07"><s1>Neonatology, Maternite Regionale Universitaire</s1>
<s2>Nancy</s2>
<s3>FRA</s3>
<sZ>7 aut.</sZ>
</fA14>
<fA14 i1="08"><s1>Department of Pediatrics, Case Western Reserve University and Rainbow Babies & Children's Hospital</s1>
<s2>Cleveland, Ohio</s2>
<s3>USA</s3>
<sZ>8 aut.</sZ>
</fA14>
<fA14 i1="09"><s1>Department of Pediatrics, University of Colorado School of Medicine</s1>
<s2>Denver, Colorado</s2>
<s3>USA</s3>
<sZ>9 aut.</sZ>
</fA14>
<fA14 i1="10"><s1>Department of Pediatric Emergency Medicine, Hôpital Robert Debré, Université Paris-7 Denis Diderot</s1>
<s2>Paris</s2>
<s3>FRA</s3>
<sZ>10 aut.</sZ>
</fA14>
<fA14 i1="11"><s1>Division of Neonatology, University of California</s1>
<s2>San Diego, California</s2>
<s3>USA</s3>
<sZ>11 aut.</sZ>
<sZ>19 aut.</sZ>
</fA14>
<fA14 i1="12"><s1>Department of Pediatrics, University of Chicago</s1>
<s2>Chicago, Illinois</s2>
<s3>USA</s3>
<sZ>12 aut.</sZ>
</fA14>
<fA14 i1="13"><s1>Division of Neonatology, Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University</s1>
<s2>Bangkok</s2>
<s3>THA</s3>
<sZ>13 aut.</sZ>
</fA14>
<fA14 i1="14"><s1>Neonatal Unit, Liverpool Women's Hospital</s1>
<s2>Liverpool</s2>
<s3>GBR</s3>
<sZ>14 aut.</sZ>
</fA14>
<fA14 i1="15"><s1>Divisian of Neonatal and Developmental Medicine, Stanford University School of Medicine and Lucile Salter Packard Children's Hospital</s1>
<s2>Palo Alto, California</s2>
<s3>USA</s3>
<sZ>15 aut.</sZ>
</fA14>
<fA14 i1="16"><s1>Division of Neonatology, Centre Hospitalier Universitaire Ste-Justine, Montreal</s1>
<s2>Quebec</s2>
<s3>CAN</s3>
<sZ>17 aut.</sZ>
</fA14>
<fA14 i1="17"><s1>Department of Pediatrics, Yale University School of Medicine</s1>
<s2>New Haven, Connecticut</s2>
<s3>USA</s3>
<sZ>18 aut.</sZ>
</fA14>
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<fC01 i1="01" l="ENG"><s0>BACKGROUND: Inhaled nitric oxide (iNO) is an effective therapy for pulmonary hypertension and hypoxic respiratory failure in term infants. Fourteen randomized controlled trials (n = 3430 infants) have been conducted on preterm infants at risk for chronic lung disease (CLD). The study results seem contradictory. DESIGN/METHODS: Individual-patient data meta-analysis included randomized controlled trials of preterm infants (<37 weeks' gestation). Outcomes were adjusted for trial differences and correlation between siblings. RESULTS: Data from 3298 infants in 12 trials (96%) were analyzed. There was no statistically significant effect of iNO on death or CLD (59% vs 61%: relative risk [RR]: 0.96 [95% confidence interval (CI): 0.92-1.01]; P = .11) or severe neurologic events on imaging (25% vs 23%: RR: 1.12 [95% CI: 0.98-1.28]; P = .09). There were no statistically significant differences in iNO effect according to any of the patient-level characteristics tested. In trials that used a starting iNO dose of >5 vs ≤5 ppm there was evidence of improved outcome (interaction P = .02); however, these differences were not observed at other levels of exposure to iNO. This result was driven primarily by 1 trial, which also differed according to overall dose, duration, timing, and indication for treatment ; a significant reduction in death or CLD (RR: 0.85 [95% CI: 0.74- 0.98]) was found. CONCLUSIONS: Routine use of iNO for treatment of respiratory failure in preterm infants cannot be recommended. The use of a higher starting dose might be associated with improved outcome, but because there were differences in the designs of these trials, it requires further examination.</s0>
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<s2>NM</s2>
<s5>01</s5>
</fC03>
<fC03 i1="01" i2="X" l="ENG"><s0>Chronic disease</s0>
<s2>NM</s2>
<s5>01</s5>
</fC03>
<fC03 i1="01" i2="X" l="SPA"><s0>Enfermedad crónica</s0>
<s2>NM</s2>
<s5>01</s5>
</fC03>
<fC03 i1="02" i2="X" l="FRE"><s0>Monoxyde d'azote</s0>
<s2>NK</s2>
<s2>FX</s2>
<s5>02</s5>
</fC03>
<fC03 i1="02" i2="X" l="ENG"><s0>Nitric oxide</s0>
<s2>NK</s2>
<s2>FX</s2>
<s5>02</s5>
</fC03>
<fC03 i1="02" i2="X" l="SPA"><s0>Nitrógeno monóxido</s0>
<s2>NK</s2>
<s2>FX</s2>
<s5>02</s5>
</fC03>
<fC03 i1="03" i2="X" l="FRE"><s0>Inhalation</s0>
<s5>03</s5>
</fC03>
<fC03 i1="03" i2="X" l="ENG"><s0>Inhalation</s0>
<s5>03</s5>
</fC03>
<fC03 i1="03" i2="X" l="SPA"><s0>Inhalación</s0>
<s5>03</s5>
</fC03>
<fC03 i1="04" i2="X" l="FRE"><s0>Prématurité</s0>
<s5>05</s5>
</fC03>
<fC03 i1="04" i2="X" l="ENG"><s0>Prematurity</s0>
<s5>05</s5>
</fC03>
<fC03 i1="04" i2="X" l="SPA"><s0>Prematuridad</s0>
<s5>05</s5>
</fC03>
<fC03 i1="05" i2="X" l="FRE"><s0>Nourrisson</s0>
<s5>06</s5>
</fC03>
<fC03 i1="05" i2="X" l="ENG"><s0>Infant</s0>
<s5>06</s5>
</fC03>
<fC03 i1="05" i2="X" l="SPA"><s0>Lactante</s0>
<s5>06</s5>
</fC03>
<fC03 i1="06" i2="X" l="FRE"><s0>Prématuré</s0>
<s5>08</s5>
</fC03>
<fC03 i1="06" i2="X" l="ENG"><s0>Premature</s0>
<s5>08</s5>
</fC03>
<fC03 i1="06" i2="X" l="SPA"><s0>Prematuro</s0>
<s5>08</s5>
</fC03>
<fC03 i1="07" i2="X" l="FRE"><s0>Pathologie du nouveau né</s0>
<s5>09</s5>
</fC03>
<fC03 i1="07" i2="X" l="ENG"><s0>Newborn diseases</s0>
<s5>09</s5>
</fC03>
<fC03 i1="07" i2="X" l="SPA"><s0>Recién nacido patología</s0>
<s5>09</s5>
</fC03>
<fC03 i1="08" i2="X" l="FRE"><s0>Donnée médicale</s0>
<s5>11</s5>
</fC03>
<fC03 i1="08" i2="X" l="ENG"><s0>Medical data</s0>
<s5>11</s5>
</fC03>
<fC03 i1="08" i2="X" l="SPA"><s0>Datos Médicos</s0>
<s5>11</s5>
</fC03>
<fC03 i1="09" i2="X" l="FRE"><s0>Métaanalyse</s0>
<s5>12</s5>
</fC03>
<fC03 i1="09" i2="X" l="ENG"><s0>Metaanalysis</s0>
<s5>12</s5>
</fC03>
<fC03 i1="09" i2="X" l="SPA"><s0>Meta-análisis</s0>
<s5>12</s5>
</fC03>
<fC03 i1="10" i2="X" l="FRE"><s0>Article synthèse</s0>
<s5>17</s5>
</fC03>
<fC03 i1="10" i2="X" l="ENG"><s0>Review</s0>
<s5>17</s5>
</fC03>
<fC03 i1="10" i2="X" l="SPA"><s0>Artículo síntesis</s0>
<s5>17</s5>
</fC03>
<fC03 i1="11" i2="X" l="FRE"><s0>Médecine factuelle</s0>
<s5>18</s5>
</fC03>
<fC03 i1="11" i2="X" l="ENG"><s0>Evidence-based medicine</s0>
<s5>18</s5>
</fC03>
<fC03 i1="11" i2="X" l="SPA"><s0>Medicina basada en pruebas</s0>
<s5>18</s5>
</fC03>
<fC03 i1="12" i2="X" l="FRE"><s0>Essai clinique</s0>
<s5>19</s5>
</fC03>
<fC03 i1="12" i2="X" l="ENG"><s0>Clinical trial</s0>
<s5>19</s5>
</fC03>
<fC03 i1="12" i2="X" l="SPA"><s0>Ensayo clínico</s0>
<s5>19</s5>
</fC03>
<fC03 i1="13" i2="X" l="FRE"><s0>Randomisation</s0>
<s5>20</s5>
</fC03>
<fC03 i1="13" i2="X" l="ENG"><s0>Randomization</s0>
<s5>20</s5>
</fC03>
<fC03 i1="13" i2="X" l="SPA"><s0>Aleatorización</s0>
<s5>20</s5>
</fC03>
<fC03 i1="14" i2="X" l="FRE"><s0>Chronique</s0>
<s5>21</s5>
</fC03>
<fC03 i1="14" i2="X" l="ENG"><s0>Chronic</s0>
<s5>21</s5>
</fC03>
<fC03 i1="14" i2="X" l="SPA"><s0>Crónico</s0>
<s5>21</s5>
</fC03>
<fC03 i1="15" i2="X" l="FRE"><s0>Pathologie des poumons</s0>
<s5>22</s5>
</fC03>
<fC03 i1="15" i2="X" l="ENG"><s0>Lung disease</s0>
<s5>22</s5>
</fC03>
<fC03 i1="15" i2="X" l="SPA"><s0>Pulmón patología</s0>
<s5>22</s5>
</fC03>
<fC03 i1="16" i2="X" l="FRE"><s0>Pathologie de l'appareil respiratoire</s0>
<s5>23</s5>
</fC03>
<fC03 i1="16" i2="X" l="ENG"><s0>Respiratory disease</s0>
<s5>23</s5>
</fC03>
<fC03 i1="16" i2="X" l="SPA"><s0>Aparato respiratorio patología</s0>
<s5>23</s5>
</fC03>
<fC03 i1="17" i2="X" l="FRE"><s0>Pédiatrie</s0>
<s5>24</s5>
</fC03>
<fC03 i1="17" i2="X" l="ENG"><s0>Pediatrics</s0>
<s5>24</s5>
</fC03>
<fC03 i1="17" i2="X" l="SPA"><s0>Pediatría</s0>
<s5>24</s5>
</fC03>
<fC07 i1="01" i2="X" l="FRE"><s0>Homme</s0>
</fC07>
<fC07 i1="01" i2="X" l="ENG"><s0>Human</s0>
</fC07>
<fC07 i1="01" i2="X" l="SPA"><s0>Hombre</s0>
</fC07>
<fC07 i1="02" i2="X" l="FRE"><s0>Pratique basée sur des preuves</s0>
</fC07>
<fC07 i1="02" i2="X" l="ENG"><s0>Evidence-based practice</s0>
</fC07>
<fC07 i1="02" i2="X" l="SPA"><s0>Práctica basada en la evidencia</s0>
</fC07>
<fN21><s1>305</s1>
</fN21>
<fN44 i1="01"><s1>OTO</s1>
</fN44>
<fN82><s1>OTO</s1>
</fN82>
</pA>
</standard>
<server><NO>PASCAL 11-0444160 INIST</NO>
<ET>Inhaled Nitric Oxide in Preterm Infants: An Individual-Patient Data Meta-analysis of Randomized Trials</ET>
<AU>ASKIE (Lisa M.); BALLARD (Roberta A.); CUTTER (Gary R.); DANI (Carlo); ELBOURNE (Diana); FIELD (David); HASCOET (Jean-Michel); HIBBS (Anna Maria); KINSELLA (John P.); MERCIER (Jean-Christophe); RICH (Wade); SCHREIBER (Michael D.); WONGSIRIDEJ (Pimol (srisuparp)); SUBHEDAR (Nim V.); VAN MEURS (Krisa P.); VOYSEY (Merryn); BARRINGTON (Keith); EHRENKRANZ (Richard A.); FINER (Neil N.)</AU>
<AF>National Health and Medical Research Council Clinical Trials Centre, University of Sydney/Sydney/Australie (1 aut., 16 aut.); Department of Pediatrics, University of California at San Francisco, School of Medicine/San Francisco, California/Etats-Unis (2 aut.); School of Public Health, University of Alabama at Birmingham/Birmingham, Alabama/Etats-Unis (3 aut.); Section of Neonatology, Department of Surgical and Medical Critical Care, Careggi University Hospital of Florence/Florence/Italie (4 aut.); Department of Medical Statistics, London School of Hygiene and Tropical Medicine/London/Royaume-Uni (5 aut.); Department of Health Science, University of Leicester/Leicester/Royaume-Uni (6 aut.); Neonatology, Maternite Regionale Universitaire/Nancy/France (7 aut.); Department of Pediatrics, Case Western Reserve University and Rainbow Babies & Children's Hospital/Cleveland, Ohio/Etats-Unis (8 aut.); Department of Pediatrics, University of Colorado School of Medicine/Denver, Colorado/Etats-Unis (9 aut.); Department of Pediatric Emergency Medicine, Hôpital Robert Debré, Université Paris-7 Denis Diderot/Paris/France (10 aut.); Division of Neonatology, University of California/San Diego, California/Etats-Unis (11 aut., 19 aut.); Department of Pediatrics, University of Chicago/Chicago, Illinois/Etats-Unis (12 aut.); Division of Neonatology, Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University/Bangkok/Thaïlande (13 aut.); Neonatal Unit, Liverpool Women's Hospital/Liverpool/Royaume-Uni (14 aut.); Divisian of Neonatal and Developmental Medicine, Stanford University School of Medicine and Lucile Salter Packard Children's Hospital/Palo Alto, California/Etats-Unis (15 aut.); Division of Neonatology, Centre Hospitalier Universitaire Ste-Justine, Montreal/Quebec/Canada (17 aut.); Department of Pediatrics, Yale University School of Medicine/New Haven, Connecticut/Etats-Unis (18 aut.)</AF>
<DT>Publication en série; Niveau analytique</DT>
<SO>Pediatrics : (Evanston); ISSN 0031-4005; Coden PEDIAU; Etats-Unis; Da. 2011; Vol. 128; No. 4; Pp. 729-739; Bibl. 44 ref.</SO>
<LA>Anglais</LA>
<EA>BACKGROUND: Inhaled nitric oxide (iNO) is an effective therapy for pulmonary hypertension and hypoxic respiratory failure in term infants. Fourteen randomized controlled trials (n = 3430 infants) have been conducted on preterm infants at risk for chronic lung disease (CLD). The study results seem contradictory. DESIGN/METHODS: Individual-patient data meta-analysis included randomized controlled trials of preterm infants (<37 weeks' gestation). Outcomes were adjusted for trial differences and correlation between siblings. RESULTS: Data from 3298 infants in 12 trials (96%) were analyzed. There was no statistically significant effect of iNO on death or CLD (59% vs 61%: relative risk [RR]: 0.96 [95% confidence interval (CI): 0.92-1.01]; P = .11) or severe neurologic events on imaging (25% vs 23%: RR: 1.12 [95% CI: 0.98-1.28]; P = .09). There were no statistically significant differences in iNO effect according to any of the patient-level characteristics tested. In trials that used a starting iNO dose of >5 vs ≤5 ppm there was evidence of improved outcome (interaction P = .02); however, these differences were not observed at other levels of exposure to iNO. This result was driven primarily by 1 trial, which also differed according to overall dose, duration, timing, and indication for treatment ; a significant reduction in death or CLD (RR: 0.85 [95% CI: 0.74- 0.98]) was found. CONCLUSIONS: Routine use of iNO for treatment of respiratory failure in preterm infants cannot be recommended. The use of a higher starting dose might be associated with improved outcome, but because there were differences in the designs of these trials, it requires further examination.</EA>
<CC>002B01; 002B30A11</CC>
<FD>Maladie chronique; Monoxyde d'azote; Inhalation; Prématurité; Nourrisson; Prématuré; Pathologie du nouveau né; Donnée médicale; Métaanalyse; Article synthèse; Médecine factuelle; Essai clinique; Randomisation; Chronique; Pathologie des poumons; Pathologie de l'appareil respiratoire; Pédiatrie</FD>
<FG>Homme; Pratique basée sur des preuves</FG>
<ED>Chronic disease; Nitric oxide; Inhalation; Prematurity; Infant; Premature; Newborn diseases; Medical data; Metaanalysis; Review; Evidence-based medicine; Clinical trial; Randomization; Chronic; Lung disease; Respiratory disease; Pediatrics</ED>
<EG>Human; Evidence-based practice</EG>
<SD>Enfermedad crónica; Nitrógeno monóxido; Inhalación; Prematuridad; Lactante; Prematuro; Recién nacido patología; Datos Médicos; Meta-análisis; Artículo síntesis; Medicina basada en pruebas; Ensayo clínico; Aleatorización; Crónico; Pulmón patología; Aparato respiratorio patología; Pediatría</SD>
<LO>INIST-6967.354000507806350150</LO>
<ID>11-0444160</ID>
</server>
</inist>
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Inhaled Nitric Oxide in Preterm Infants: An Individual-Patient Data Meta-analysis of Randomized Trials

Inhaled Nitric Oxide in Preterm Infants: An Individual-Patient Data Meta-analysis of Randomized Trials

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