Back to Search Start Over

The Randomized, Controlled Trial of Late Surfactant: Effects on Respiratory Outcomes at 1 Year Corrected Age

Authors :
Ramasubbareddy Dhanireddy
William E Truog
Catherine M. Bendel
Frances R. Koch
Roberta A. Ballard
Victor J. McKay
Sherry E. Courtney
Robin H. Steinhorn
Ellen M. Bendel-Stenzel
Jeanette M. Asselin
Lisa Palermo
Dennis E. Mayock
Dennis M. Black
Anna Maria Hibbs
Roberta L. Keller
Philip L. Ballard
David J. Durand
Mark C. Mammel
Katherine C. Wai
Jeffrey D. Merrill
Rajan Wadhawan
Elizabeth E. Rogers
Mark L. Hudak
Rita M. Ryan
Jennifer Helderman
Nicolas F M Porta
Eric C. Eichenwald
Publication Year :
2017

Abstract

Objective To determine the effects of late surfactant on respiratory outcomes determined at 1-year corrected age in the Trial of Late Surfactant (TOLSURF), which randomized newborns of extremely low gestational age (≤28 weeks' gestational age) ventilated at 7-14 days to late surfactant and inhaled nitric oxide vs inhaled nitric oxide-alone (control). Study design Caregivers were surveyed in a double-blinded manner at 3, 6, 9, and 12 months' corrected age to collect information on respiratory resource use (infant medication use, home support, and hospitalization). Infants were classified for composite outcomes of pulmonary morbidity (no PM, determined in infants with no reported respiratory resource use) and persistent PM (determined in infants with any resource use in ≥3 surveys). Results Infants (n = 450, late surfactant n = 217, control n = 233) were 25.3 ± 1.2 weeks' gestation and 713 ± 164 g at birth. In the late surfactant group, fewer infants received home respiratory support than in the control group (35.8% vs 52.9%, relative benefit [RB] 1.28 [95% CI 1.07-1.55]). There was no benefit of late surfactant for No PM vs PM (RB 1.27; 95% CI 0.89-1.81) or no persistent PM vs persistent PM (RB 1.01; 95% CI 0.87-1.17). After adjustment for imbalances in baseline characteristics, relative benefit of late surfactant treatment increased: RB 1.40 (95% CI 0.89-1.80) for no PM and RB 1.24 (95% CI 1.08-1.42) for no persistent PM. Conclusion Treatment of newborns of extremely low gestational age with late surfactant in combination with inhaled nitric oxide decreased use of home respiratory support and may decrease persistent pulmonary morbidity. Trial registration ClinicalTrials.gov : NCT01022580

Details

Language :
English
Database :
OpenAIRE
Accession number :
edsair.doi.dedup.....bb7c75dbeda0161173bad16f6f9f5350