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

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.

Postnatal steroids in extremely low birth weight infants: betamethasone or hydrocortisone?

AIM: To compare the efficacy and tolerance of betamethasone (BTM) and hydrocortisone (HC) in weaning extremely low birth weight (ELBW) infants with bronchopulmonary dysplasia (BPD) from the ventilator. METHODS: Monocentric, retrospective, cohort analysis based on prospective, standardized collection of data between 2005 and 2011 in ELBW receiving postnatal steroids (PS) after the second week of life. We used BTM for the first 4 years, and thereafter HC. We compared extubation rates, growth, glycaemia and blood pressure. RESULTS: Sixty-seven infants received PS: 35 BTM and 32 HC. Most infants (83% BTM vs. 72% HC) were extubated during treatment (p = 0.281). During PS, the need for insulin was similar. Mean arterial blood pressure was similar at day 3 of PS, but was significantly lower in infants treated by BTM 30 days after the end of treatment. The z-scores for body weight and head circumference indicated significantly greater loss in BTM than HC group. This persisted only for body weight after adjustment for differences in energy intake and corticosteroid dose. CONCLUSION: Our study suggests that HC may be as efficient as BTM in facilitating the extubation of ELBW infants, without short-term adverse effects. Blood pressure monitoring and investigation of long-term neurodevelopment are nevertheless needed.