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Randomized Trial of Late Surfactant Treatment in Ventilated Preterm Infants Receiving Inhaled Nitric Oxide.
- Source :
-
The Journal of pediatrics [J Pediatr] 2016 Jan; Vol. 168, pp. 23-29.e4. Date of Electronic Publication: 2015 Oct 21. - Publication Year :
- 2016
-
Abstract
- Objective: To assess whether late surfactant treatment in extremely low gestational age (GA) newborn infants requiring ventilation at 7-14 days, who often have surfactant deficiency and dysfunction, safely improves survival without bronchopulmonary dysplasia (BPD).<br />Study Design: Extremely low GA newborn infants (GA ≤28 0/7 weeks) who required mechanical ventilation at 7-14 days were enrolled in a randomized, masked controlled trial at 25 US centers. All infants received inhaled nitric oxide and either surfactant (calfactant/Infasurf) or sham instillation every 1-3 days to a maximum of 5 doses while intubated. The primary outcome was survival at 36 weeks postmenstrual age (PMA) without BPD, as evaluated by physiological oxygen/flow reduction.<br />Results: A total of 511 infants were enrolled between January 2010 and September 2013. There were no differences between the treated and control groups in mean birth weight (701 ± 164 g), GA (25.2 ± 1.2 weeks), percentage born at GA <26 weeks (70.6%), race, sex, severity of lung disease at enrollment, or comorbidities of prematurity. Survival without BPD did not differ between the treated and control groups at 36 weeks PMA (31.3% vs 31.7%; relative benefit, 0.98; 95% CI, 0.75-1.28; P = .89) or 40 weeks PMA (58.7% vs 54.1%; relative benefit, 1.08; 95% CI, 0.92-1.27; P = .33). There were no between-group differences in serious adverse events, comorbidities of prematurity, or severity of lung disease to 36 weeks.<br />Conclusion: Late treatment with up to 5 doses of surfactant in ventilated premature infants receiving inhaled nitric oxide was well tolerated, but did not improve survival without BPD at 36 or 40 weeks. Pulmonary and neurodevelopmental assessments are ongoing.<br />Trial Registration: ClinicalTrials.gov: NCT01022580.<br /> (Copyright © 2016 Elsevier Inc. All rights reserved.)
- Subjects :
- Administration, Inhalation
Bronchopulmonary Dysplasia epidemiology
Female
Humans
Infant, Newborn
Infant, Premature
Infant, Premature, Diseases mortality
Infant, Premature, Diseases therapy
Infant, Very Low Birth Weight
Male
Nitric Oxide adverse effects
Pulmonary Surfactants adverse effects
Respiration, Artificial mortality
Survival Rate
United States
Bronchopulmonary Dysplasia etiology
Nitric Oxide administration & dosage
Pulmonary Surfactants therapeutic use
Respiration, Artificial adverse effects
Subjects
Details
- Language :
- English
- ISSN :
- 1097-6833
- Volume :
- 168
- Database :
- MEDLINE
- Journal :
- The Journal of pediatrics
- Publication Type :
- Academic Journal
- Accession number :
- 26500107
- Full Text :
- https://doi.org/10.1016/j.jpeds.2015.09.031