title: Late Surfactant Administration in Very Preterm Neonates With Prolonged Respiratory Distress and Pulmonary Outcome at 1 Year of Age: A Randomized Clinical Trial.
abstract: OBJECTIVE
  Although immature neonate survival has improved, there is an increased risk of developing bronchopulmonary dysplasia, leading to significant respiratory morbidity. Measures to reduce bronchopulmonary dysplasia are not always effective or have important adverse effects.
  
  
  OBJECTIVE
  To evaluate the effect of late surfactant administration in infants with prolonged respiratory distress on ventilation duration, respiratory outcome at 36 weeks' postmenstrual age, and at 1 year postnatal age.
  
  
  METHODS
  Double-blind randomized clinical trial at 13 level III French perinatal centers. Participants included 118 neonates at less than 33 weeks' gestation who still required mechanical ventilation on day 14 (SD, 2) with fraction of inspired oxygen of more than 0.30. All survivors were eligible for follow-up. We performed an intent-to-treat analysis.
  
  
  METHODS
  Infants received 200 mg/kg of poractant alfa (surfactant) or air after randomization. At 1 year, after parents' interview, infants underwent physical examination by pediatricians not aware of the randomization.
  
  
  METHODS
  The duration of ventilation was the primary outcome. The combined outcome of death or bronchopulmonary dysplasia at 36 weeks' postmenstrual age and respiratory morbidity at 1 year of age were the main secondary outcome measures.
  
  
  RESULTS
  Of the 118 infants who participated in the study, 65 (55%) were male. Fraction of inspired oxygen requirements dropped after surfactant, but not air, for up to 24 hours after instillation (0.36 [0.11] vs 0.43 [0.18]; P < .005). Severe bronchopulmonary dysplasia/death rates at 36 weeks' postmenstrual age were similar (27.1% vs 35.6%; P = .32). Less surfactant-treated infants needed rehospitalization for respiratory problems after discharge (28.3% vs 51.1%; P = .03); 39.5% vs 50% needed respiratory physical therapy (P = .35). No difference was observed for weight (7.8 [1.2] kg vs 7.6 [1.1] kg), height (69 [5] cm vs 69 [3] cm), and head circumference (44.4 [1.7] cm vs 44.2 [1.7] cm) measured at follow-up, nor for neurodevelopment outcome.
  
  
  CONCLUSIONS
  Late surfactant administration did not alter the early course of bronchopulmonary dysplasia. However, surfactant-treated infants had reduced respiratory morbidity prior to 1 year of age.
  
  
  BACKGROUND
  clinicaltrials.gov Identifier: NCT01039285.
authors.affiliation: Maternite Regionale Universitaire, EA 3450 Devah, Université de Lorraine, Nancy, France.
authors.forename: Jean-Michel
authors.initials: JM
authors.lastname: Hascoët
authors.affiliation: Hôpital de la Croix-Rousse, Hospices Civils de Lyon, Lyon, France.
authors.forename: Jean-Charles
authors.initials: JC
authors.lastname: Picaud
authors.affiliation: Assistance Publique-Hopitaux Marseille, Marseille, France.
authors.forename: Isabelle
authors.initials: I
authors.lastname: Ligi
authors.affiliation: Centre Hospitalier Universitaire Rouen, Rouen, France.
authors.forename: Thierry
authors.initials: T
authors.lastname: Blanc
authors.affiliation: Centre Hospitalier Universitaire Amiens, Amiens, France.
authors.forename: Francois
authors.initials: F
authors.lastname: Moreau
authors.affiliation: Centre Hospitalier Montreuil, Montreuil, France.
authors.forename: Marie-Frederique
authors.initials: MF
authors.lastname: Pinturier
authors.affiliation: Assistance Publique-Hopitaux Clamart, Clamart, France.
authors.forename: Véronique
authors.initials: V
authors.lastname: Zupan
authors.affiliation: Centre Hospitalier Arras, Arras, France.
authors.forename: Isaura
authors.initials: I
authors.lastname: Guilhoto
authors.affiliation: Maternite Regionale Universitaire, EA 3450 Devah, Université de Lorraine, Nancy, France.
authors.forename: Isabelle R M
authors.initials: IR
authors.lastname: Hamon
authors.affiliation: Centre Hospitalier Universitaire Caen, Caen, France.
authors.forename: Ceneric
authors.initials: C
authors.lastname: Alexandre
authors.affiliation: Centre Hospitalier Universitaire Tours, Tours, France.
authors.forename: Antoine
authors.initials: A
authors.lastname: Bouissou
authors.affiliation: Centre Hospitalier Universitaire Lille, Lille, France.
authors.forename: Laurent
authors.initials: L
authors.lastname: Storme
authors.affiliation: Assistance Publique-Hopitaux Paris Port Royal, Paris, France.
authors.forename: Juliana
authors.initials: J
authors.lastname: Patkai
authors.affiliation: Centre Hospitalier Universitaire Reims, Reims, France.
authors.forename: Mickael
authors.initials: M
authors.lastname: Pomedio
authors.affiliation: Maternite Regionale Universitaire, EA 3450 Devah, Université de Lorraine, Nancy, France.
authors.forename: Mahmoud
authors.initials: M
authors.lastname: Rouabah
authors.affiliation: Hôpital de la Croix-Rousse, Hospices Civils de Lyon, Lyon, France.
authors.forename: Ludivine
authors.initials: L
authors.lastname: Coletto
authors.affiliation: Maternite Regionale Universitaire, EA 4360 APEMAC, Université de Lorraine, Nancy, France.
authors.forename: Rachel
authors.initials: R
authors.lastname: Vieux
mesh_terms: D001688:Biological Products / Q000008:administration & dosage*; D001997:Bronchopulmonary Dysplasia / Q000503:physiopathology; D004311:Double-Blind Method; D005260:Female; D005865:Gestational Age; D006801:Humans; D007223:Infant; D062071:Infant, Extremely Premature; D007231:Infant, Newborn; D008168:Lung / Q000187:drug effects / Q000503:physiopathology; D008297:Male; D010743:Phospholipids / Q000008:administration & dosage*; D011663:Pulmonary Surfactants / Q000008:administration & dosage*; D012121:Respiration, Artificial / Q000379:methods; D012127:Respiratory Distress Syndrome, Newborn / Q000188:drug therapy* / Q000503:physiopathology; D013997:Time Factors
chemical_list: D001688:Biological Products; D010743:Phospholipids; D011663:Pulmonary Surfactants; C068291:poractant alfa