Serveur d'exploration sur les relations entre la France et l'Australie

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

Identifieur interne : 006992 ( Main/Exploration ); précédent : 006991; suivant : 006993

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

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

Source :

RBID : Pascal:11-0444160

Descripteurs français

English descriptors

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.

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Le document en format XML

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<placeName>
<region type="state">Californie</region>
</placeName>
</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 wicri:level="2">
<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>
<country>États-Unis</country>
<placeName>
<region type="state">Illinois</region>
</placeName>
</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 wicri:level="1">
<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>
<country>Thaïlande</country>
<wicri:noRegion>Bangkok</wicri:noRegion>
</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 wicri:level="1">
<inist:fA14 i1="14">
<s1>Neonatal Unit, Liverpool Women's Hospital</s1>
<s2>Liverpool</s2>
<s3>GBR</s3>
<sZ>14 aut.</sZ>
</inist:fA14>
<country>Royaume-Uni</country>
<wicri:noRegion>Liverpool</wicri:noRegion>
</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 wicri:level="2">
<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>
<country>États-Unis</country>
<placeName>
<region type="state">Californie</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Voysey, Merryn" sort="Voysey, Merryn" uniqKey="Voysey M" first="Merryn" last="Voysey">Merryn Voysey</name>
<affiliation wicri:level="4">
<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>
<country>Australie</country>
<placeName>
<settlement type="city">Sydney</settlement>
<region type="état">Nouvelle-Galles du Sud</region>
<settlement type="city">Sydney</settlement>
</placeName>
<orgName type="university">Université de Sydney</orgName>
</affiliation>
</author>
<author>
<name sortKey="Barrington, Keith" sort="Barrington, Keith" uniqKey="Barrington K" first="Keith" last="Barrington">Keith Barrington</name>
<affiliation wicri:level="3">
<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>
<country>Canada</country>
<placeName>
<settlement type="city">Montréal</settlement>
<region type="state">Québec</region>
</placeName>
</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 wicri:level="2">
<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>
<country>États-Unis</country>
<placeName>
<region type="state">Connecticut</region>
</placeName>
</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 wicri:level="2">
<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>
<country>États-Unis</country>
<placeName>
<region type="state">Californie</region>
</placeName>
</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>
<keywords scheme="Wicri" type="topic" xml:lang="fr">
<term>Maladie chronique</term>
<term>Pédiatrie</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<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>
<affiliations>
<list>
<country>
<li>Australie</li>
<li>Canada</li>
<li>France</li>
<li>Italie</li>
<li>Royaume-Uni</li>
<li>Thaïlande</li>
<li>États-Unis</li>
</country>
<region>
<li>Alabama</li>
<li>Angleterre</li>
<li>Californie</li>
<li>Colorado</li>
<li>Connecticut</li>
<li>Grand Est</li>
<li>Grand Londres</li>
<li>Illinois</li>
<li>Lorraine (région)</li>
<li>Nouvelle-Galles du Sud</li>
<li>Ohio</li>
<li>Québec</li>
<li>Île-de-France</li>
</region>
<settlement>
<li>Londres</li>
<li>Montréal</li>
<li>Nancy</li>
<li>Paris</li>
<li>Sydney</li>
</settlement>
<orgName>
<li>Université de Sydney</li>
</orgName>
</list>
<tree>
<country name="Australie">
<region name="Nouvelle-Galles du Sud">
<name sortKey="Askie, Lisa M" sort="Askie, Lisa M" uniqKey="Askie L" first="Lisa M." last="Askie">Lisa M. Askie</name>
</region>
<name sortKey="Voysey, Merryn" sort="Voysey, Merryn" uniqKey="Voysey M" first="Merryn" last="Voysey">Merryn Voysey</name>
</country>
<country name="États-Unis">
<region name="Californie">
<name sortKey="Ballard, Roberta A" sort="Ballard, Roberta A" uniqKey="Ballard R" first="Roberta A." last="Ballard">Roberta A. Ballard</name>
</region>
<name sortKey="Cutter, Gary R" sort="Cutter, Gary R" uniqKey="Cutter G" first="Gary R." last="Cutter">Gary R. Cutter</name>
<name sortKey="Ehrenkranz, Richard A" sort="Ehrenkranz, Richard A" uniqKey="Ehrenkranz R" first="Richard A." last="Ehrenkranz">Richard A. Ehrenkranz</name>
<name sortKey="Finer, Neil N" sort="Finer, Neil N" uniqKey="Finer N" first="Neil N." last="Finer">Neil N. Finer</name>
<name sortKey="Hibbs, Anna Maria" sort="Hibbs, Anna Maria" uniqKey="Hibbs A" first="Anna Maria" last="Hibbs">Anna Maria Hibbs</name>
<name sortKey="Kinsella, John P" sort="Kinsella, John P" uniqKey="Kinsella J" first="John P." last="Kinsella">John P. Kinsella</name>
<name sortKey="Rich, Wade" sort="Rich, Wade" uniqKey="Rich W" first="Wade" last="Rich">Wade Rich</name>
<name sortKey="Schreiber, Michael D" sort="Schreiber, Michael D" uniqKey="Schreiber M" first="Michael D." last="Schreiber">Michael D. Schreiber</name>
<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>
</country>
<country name="Italie">
<noRegion>
<name sortKey="Dani, Carlo" sort="Dani, Carlo" uniqKey="Dani C" first="Carlo" last="Dani">Carlo Dani</name>
</noRegion>
</country>
<country name="Royaume-Uni">
<region name="Angleterre">
<name sortKey="Elbourne, Diana" sort="Elbourne, Diana" uniqKey="Elbourne D" first="Diana" last="Elbourne">Diana Elbourne</name>
</region>
<name sortKey="Field, David" sort="Field, David" uniqKey="Field D" first="David" last="Field">David Field</name>
<name sortKey="Subhedar, Nim V" sort="Subhedar, Nim V" uniqKey="Subhedar N" first="Nim V." last="Subhedar">Nim V. Subhedar</name>
</country>
<country name="France">
<region name="Grand Est">
<name sortKey="Hascoet, Jean Michel" sort="Hascoet, Jean Michel" uniqKey="Hascoet J" first="Jean-Michel" last="Hascoet">Jean-Michel Hascoet</name>
</region>
<name sortKey="Mercier, Jean Christophe" sort="Mercier, Jean Christophe" uniqKey="Mercier J" first="Jean-Christophe" last="Mercier">Jean-Christophe Mercier</name>
</country>
<country name="Thaïlande">
<noRegion>
<name sortKey="Wongsiridej, Pimol Srisuparp" sort="Wongsiridej, Pimol Srisuparp" uniqKey="Wongsiridej P" first="Pimol Srisuparp" last="Wongsiridej">Pimol Srisuparp Wongsiridej</name>
</noRegion>
</country>
<country name="Canada">
<region name="Québec">
<name sortKey="Barrington, Keith" sort="Barrington, Keith" uniqKey="Barrington K" first="Keith" last="Barrington">Keith Barrington</name>
</region>
</country>
</tree>
</affiliations>
</record>

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