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Journal of Pediatrics, The

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The Randomized, Controlled Trial of Late Surfactant: Effects on Respiratory Outcomes at 1-Year Corrected Age - 18/04/17

Doi : 10.1016/j.jpeds.2016.12.059 
Roberta L. Keller, MD 1, * , Eric C. Eichenwald, MD 2, Anna Maria Hibbs, MD 3, Elizabeth E. Rogers, MD 1, Katherine C. Wai, MS 4, Dennis M. Black, PhD 5, Philip L. Ballard, MD, PhD 1, Jeanette M. Asselin, MS, RRT-NPS 6, William E. Truog, MD 7, Jeffrey D. Merrill, MD 6, Mark C. Mammel, MD 8, Robin H. Steinhorn, MD 9, Rita M. Ryan, MD 10, David J. Durand, MD 6, Catherine M. Bendel, MD 11, Ellen M. Bendel-Stenzel, MD 8, Sherry E. Courtney, MD 12, Ramasubbareddy Dhanireddy, MD 13, Mark L. Hudak, MD 14, Frances R. Koch, MD 10, Dennis E. Mayock, MD 15, Victor J. McKay, MD 16, Jennifer Helderman, MD 17, Nicolas F. Porta, MD 18, Rajan Wadhawan, MD 19, Lisa Palermo, MS 5, Roberta A. Ballard, MD 1
on behalf of the

TOLSURF Study Group*

  List of additional members of Trial of Late Surfactant (TOLSURF) Study Group is available at www.jpeds.com (Appendix).

1 Department of Pediatrics, University of California San Francisco, San Francisco, CA 
2 Department of Pediatrics, University of Texas, Houston, TX 
3 Department of Pediatrics, Case Western Reserve University, Cleveland, OH 
4 University of California San Francisco School of Medicine, San Francisco, CA 
5 Department of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, CA 
6 Department of Pediatrics, Benioff Children's Hospital Oakland, Oakland, CA 
7 Department of Pediatrics, Children's Mercy Hospital, Kansas City, MO 
8 Department of Pediatrics, Children's Hospital and Clinics of Minnesota, St Paul and Minneapolis, MN 
9 Department of Pediatrics, Children's National Medical Center, Washington, DC 
10 Department of Pediatrics, Medical University of South Carolina, Charleston, SC 
11 Department of Pediatrics, University of Minnesota, Minneapolis, MN 
12 Department of Pediatrics, University of Arkansas for Medical Sciences, Little Rock, AR 
13 Department of Pediatrics, University of Tennessee Health Science Center, Memphis, TN 
14 Department of Pediatrics, University of Florida College of Medicine, Jacksonville, FL 
15 Department of Pediatrics, University of Washington, Seattle, WA 
16 Department of Pediatrics, All Children's Hospital, St. Petersburg, FL 
17 Department of Pediatrics, Wake Forest School of Medicine/Forsyth Medical Center, Winston-Salem, NC 
18 Department of Pediatrics, Northwestern University Feinberg School of Medicine, Chicago, IL 
19 Department of Pediatrics, Florida Hospital for Children, Orlando, FL 

*Reprint requests: Department of Pediatrics, University of California San Francisco, UCSF Box 0734, San Francisco, CA 94143.Department of PediatricsUniversity of California San FranciscoUCSF Box 0734San FranciscoCA94143

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

Le texte complet de cet article est disponible en PDF.

Keywords : bronchopulmonary dysplasia, prematurity, pulmonary morbidity, wheeze

Abbreviations : BD, BPD, ELGAN, GA, ICS, iNO, NO CLD, PM, PMA, RB, TOLSURF


Plan


 TOLSURF was funded by National Heart, Lung, and Blood Institute (NHLBI; U01 HL094338, U01 HL094355, and UL1 TR000004 [to K.W.]). The NHLBI Scientific Officer, Carol Blaisdell, MD, was present and participated in all Steering Committee meetings as a nonvoting member. Ikaria Inc and ONY Inc provided drugs for the conduct of the trial but had no input into study design, data analysis, data interpretation or manuscript preparation. R.S. serves as Associate Editor of The Journal of Pediatrics. The other authors declare no conflicts of interest.
 Portions of the study were presented as an abstract at the meeting of the Pediatric Academic Societies, April 30-May 3, 2016, Baltimore, MD.


© 2016  Elsevier Inc. Tous droits réservés.
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Vol 183

P. 19 - avril 2017 Retour au numéro
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