Randomized Trial of Late Surfactant Treatment in Ventilated Preterm Infants Receiving Inhaled Nitric Oxide

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). Study design Extremely low GA newbo...

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Veröffentlicht in:	The Journal of pediatrics 2016-01, Vol.168, p.23-29.e4
Hauptverfasser:	Ballard, Roberta A., MD, Keller, Roberta L., MD, Black, Dennis M., PhD, Ballard, Philip L., MD, PhD, Merrill, Jeffrey D., MD, Eichenwald, Eric C., MD, Truog, William E., MD, Mammel, Mark C., MD, Steinhorn, Robin H., MD, Rogers, Elizabeth E., MD, Ryan, Rita M., MD, Durand, David J., MD, Asselin, Jeanette M., MS, RRT-NPS, Bendel, Catherine M., MD, Bendel-Stenzel, Ellen M., MD, Courtney, Sherry E., MD, Dhanireddy, Ramasubbareddy, MD, Hudak, Mark L., MD, Koch, Frances R., MD, Mayock, Dennis E., MD, McKay, Victor J., MD, O'Shea, T. Michael, MD, Porta, Nicolas F., MD, Wadhawan, Rajan, MD, Palermo, Lisa, MS
Format:	Artikel
Sprache:	eng
Schlagworte:	Administration, Inhalation Bronchopulmonary Dysplasia - epidemiology Bronchopulmonary Dysplasia - etiology Female Humans Infant, Newborn Infant, Premature Infant, Premature, Diseases - mortality Infant, Premature, Diseases - therapy Infant, Very Low Birth Weight Male Nitric Oxide - administration & dosage Nitric Oxide - adverse effects Pediatrics Pulmonary Surfactants - adverse effects Pulmonary Surfactants - therapeutic use Respiration, Artificial - adverse effects Respiration, Artificial - mortality Survival Rate United States
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Zusammenfassung:	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). 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. 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
ISSN:	0022-3476 1097-6833
DOI:	10.1016/j.jpeds.2015.09.031