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American Academy of Pediatrics
Article

Two-Year Outcomes of a Randomized Controlled Trial of Inhaled Nitric Oxide in Premature Infants

Xavier Durrmeyer, Helmut Hummler, Manuel Sanchez-Luna, Virgilio P. Carnielli, David Field, Anne Greenough, Bart Van Overmeire, Baldvin Jonsson, Mikko Hallman, Jean-Christophe Mercier, Neil Marlow, Samantha Johnson and James Baldassarre
Pediatrics September 2013, 132 (3) e695-e703; DOI: https://doi.org/10.1542/peds.2013-0007
Xavier Durrmeyer
aDepartment of Neonatology, CRC, Centre Hospitalier Intercommunal de Créteil, Créteil, France;
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Helmut Hummler
bDivision of Neonatology, Children’s Hospital, University of Ulm, Ulm, Germany;
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Manuel Sanchez-Luna
cDepartment of Neonatology, Hospital Universitario Gregorio Marañon, Madrid, Spain;
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Virgilio P. Carnielli
dDivision of Neonatology, Department of Clinical Sciences, Polytechnic University of Marche and Azienda Ospedaliero Universitaria Ospedali Riuniti, Ancona, Italy
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David Field
eDepartment of Health Sciences, University of Leicester, Leicester, United Kingdom;
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Anne Greenough
fDivision of Asthma, Allergy and Lung Biology, King’s College, London, United Kingdom;
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Bart Van Overmeire
gDepartment of Neonatology, Antwerp University Hospital, Antwerp, Belgium;
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Baldvin Jonsson
hDepartment of Neonatology, Karolinska Institute, Stockholm, Sweden;
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Mikko Hallman
iDepartment of Pediatrics, Oulu University Hospital and University of Oulu, Oulu, Finland;
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Jean-Christophe Mercier
jHôpital Robert Debré, Paris, France;
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Neil Marlow
kInstitute for Women's Health, University College London, London, United Kingdom; and
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Samantha Johnson
eDepartment of Health Sciences, University of Leicester, Leicester, United Kingdom;
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James Baldassarre
lDepartment of Clinical Research, Ikaria, Inc, Hampton, New Jersey
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Abstract

BACKGROUND AND OBJECTIVES The European Union Nitric Oxide trial was designed to assess the potential benefits of inhaled nitric oxide (iNO) compared with placebo in infants with respiratory failure. This follow-up study evaluated respiratory, neurodevelopmental, and other outcomes for infants entered into the European Union Nitric Oxide trial to age 2 years.

METHODS: In a multicenter, randomized, double-blind study, preterm infants born at <29 weeks’ gestation with moderate respiratory failure were allocated to receive iNO (5 ppm) or placebo for 7 to 21 days. Subjects underwent assessments at 1 and 2 years corrected for prematurity.

RESULTS: At 36 weeks’ postmenstrual age, 696 of 792 infants were alive; 4 in the iNO arm subsequently died before age 2 years compared with 7 in the control arm. We evaluated 95% of the survivors at 12 months and 90% at 2 years. In the iNO arm, 244 of 363 (67.2%) infants had survived without disability at age 2 years compared with 270 of 374 (72.2%) who received placebo (P = .094). Mean (SD) cognitive composite scores (Bayley Scales of Infant and Toddler Development, third edition) were 94 (13) in the iNO group and 95 (14) in the placebo group; in the iNO group, 19% scored <85 and 9.5% developed cerebral palsy compared with 13.3% and 9%, respectively. There were no significant differences in hospitalizations overall or due to respiratory illness in use of home oxygen therapy or respiratory medications, in growth, or in other health outcomes.

CONCLUSIONS: At 2 years of age, low-dose (5 ppm) iNO started early (<24 hours after birth) for a median of 20 days did not affect neurodevelopmental or other health outcomes.

  • inhaled nitric oxide
  • premature infants
  • growth
  • developmental outcomes
  • randomized controlled trial
  • Abbreviations:
    Bayley-III —
    Bayley Scales of Infant and Toddler Development, third edition
    BPD —
    bronchopulmonary dysplasia
    EUNO —
    European Union Nitric Oxide
    GMFCS —
    Gross Motor Function Classification System for Cerebral Palsy
    iNO —
    inhaled nitric oxide
    ROP —
    retinopathy of prematurity
    • Accepted June 3, 2013.
    • Copyright © 2013 by the American Academy of Pediatrics

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    Vol. 132, Issue 3
    1 Sep 2013
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    Two-Year Outcomes of a Randomized Controlled Trial of Inhaled Nitric Oxide in Premature Infants
    Xavier Durrmeyer, Helmut Hummler, Manuel Sanchez-Luna, Virgilio P. Carnielli, David Field, Anne Greenough, Bart Van Overmeire, Baldvin Jonsson, Mikko Hallman, Jean-Christophe Mercier, Neil Marlow, Samantha Johnson, James Baldassarre
    Pediatrics Sep 2013, 132 (3) e695-e703; DOI: 10.1542/peds.2013-0007

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    Two-Year Outcomes of a Randomized Controlled Trial of Inhaled Nitric Oxide in Premature Infants
    Xavier Durrmeyer, Helmut Hummler, Manuel Sanchez-Luna, Virgilio P. Carnielli, David Field, Anne Greenough, Bart Van Overmeire, Baldvin Jonsson, Mikko Hallman, Jean-Christophe Mercier, Neil Marlow, Samantha Johnson, James Baldassarre
    Pediatrics Sep 2013, 132 (3) e695-e703; DOI: 10.1542/peds.2013-0007
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    Subjects

    • Pulmonology
      • Pulmonology
    • Fetus/Newborn Infant
      • Fetus/Newborn Infant
      • Neonatology

    Keywords

    • inhaled nitric oxide
    • premature infants
    • growth
    • developmental outcomes
    • randomized controlled trial
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