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Original Investigation |

Late Surfactant Administration in Very Preterm Neonates With Prolonged Respiratory Distress and Pulmonary Outcome at 1 Year of Age A Randomized Clinical Trial

Jean-Michel Hascoët, MD1; Jean-Charles Picaud, MD, PhD2; Isabelle Ligi, MD3; Thierry Blanc, MD4; Francois Moreau, MD5 ; Marie-Frederique Pinturier, MD6 ; Véronique Zupan, MD7; Isaura Guilhoto, MD8; Isabelle R. M. Hamon, MD, PhD1; Ceneric Alexandre, MD9; Antoine Bouissou, MD10; Laurent Storme, MD, PhD11; Juliana Patkai, MD12; Mickael Pomedio, MD13; Mahmoud Rouabah, MD1; Ludivine Coletto, MD2; Rachel Vieux, MD, PhD14
[+] Author Affiliations
1Maternite Regionale Universitaire, EA 3450 Devah, Université de Lorraine, Nancy, France
2Hôpital de la Croix-Rousse, Hospices Civils de Lyon, Lyon, France
3Assistance Publique-Hopitaux Marseille, Marseille, France
4Centre Hospitalier Universitaire Rouen, Rouen, France
5 Centre Hospitalier Universitaire Amiens, Amiens, France
6 Centre Hospitalier Montreuil, Montreuil, France
7Assistance Publique-Hopitaux Clamart, Clamart, France
8Centre Hospitalier Arras, Arras, France
9Centre Hospitalier Universitaire Caen, Caen, France
10Centre Hospitalier Universitaire Tours, Tours, France
11Centre Hospitalier Universitaire Lille, Lille, France
12Assistance Publique-Hopitaux Paris Port Royal, Paris, France
13Centre Hospitalier Universitaire Reims, Reims, France
14Maternite Regionale Universitaire, EA 4360 APEMAC, Université de Lorraine, Nancy, France
JAMA Pediatr. 2016;170(4):365-372. doi:10.1001/jamapediatrics.2015.4617.
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Importance  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.

Design, Setting, and Participants  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.

Interventions  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.

Main Outcomes and Measures  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 and Relevance  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.

Trial Registration  clinicaltrials.gov Identifier: NCT01039285

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Figure 1.
CURDYS Study Diagram Flow
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Figure 2.
Changes in Fraction of Inspired Oxygen (FiO2) Requirements for 72 Hours After Surfactant (Surfact) or Air (Control) Instillation (Mean [SD])

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