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Multicenter Study
. 2014 Sep;99(5):F386-90.
doi: 10.1136/archdischild-2014-306057. Epub 2014 May 29.

Change in practice after the Surfactant, Positive Pressure and Oxygenation Randomised Trial

Jaclyn M LeVan  1 , Luc P Brion  2 , Lisa A Wrage  3 , Marie G Gantz  3 , Myra H Wyckoff  2 , Pablo J Sánchez  4 , Roy Heyne  2 , Mambarambath Jaleel  2 , Neil N Finer  5 , Waldemar A Carlo  6 , Abhik Das  3 , Barbara J Stoll  7 , Rosemary D Higgins  8 ; Eunice Kennedy Shriver NICHD Neonatal Research Network
Affiliations
Multicenter Study

Change in practice after the Surfactant, Positive Pressure and Oxygenation Randomised Trial

Jaclyn M LeVan et al. Arch Dis Child Fetal Neonatal Ed. 2014 Sep.

Abstract

Objective: To test the hypothesis that the proportion of endotracheal intubation (ETI) in the delivery room (DR) decreased in Neonatal Research Network (NRN) centres after the National Institute of Child Health and Human Development NRN Surfactant, Positive Pressure, and Oxygenation Randomised Trial (SUPPORT).

Design: Retrospective cohort study using the prospective NRN generic database.

Setting: Eleven centres that participated in the SUPPORT trial and remained part of the NRN. Preterm neonates 24(0/7)-27(6/7) weeks' gestational age enrolled in the SUPPORT trial were randomised to: (1) DR continuous positive airway pressure or DR ETI with early surfactant administration; and (2) oxygen saturation targets of 85-89% or 91-95%. The prior NRN feasibility trial had assessed the feasibility of randomisation to continuous positive airway pressure versus ETI.

Patients: Infants 24(0/7)-27(6/7) weeks' gestational age, excluding infants with syndromes or major malformations and those on comfort care only.

Main outcome measure: Proportion of DR ETI.

Results: The proportion of DR ETI decreased significantly in the group of infants from centres that had not participated in the feasibility trial (91% before vs 75% after SUPPORT, adjusted relative risk 0.86, 95% CI 0.83-0.89, p<0.0001) but not in the group of infants from the other centres, where the proportion of ETI was already lower prior to initiation of the SUPPORT trial (61% before vs 58% after SUPPORT, adjusted relative risk 0.96, 95% CI 0.89 to 1.05, p=0.40).

Conclusion: This study shows that DR ETI changed after SUPPORT only in NRN centres that had not participated in a similar trial.

Trial registration number: NCT00063063 (GDB) and NCT00233324 (SUPPORT).

Keywords: Clinical Procedures; Data Collection; Neonatology; Respiratory.

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Figures

Figure 1
Figure 1
Flow diagram representing all infants in the Generic Database during the two study periods and those included in the study.
Figure 2
Figure 2
Per cent delivery room intubations in pre/post-SUPPORT periods for the eleven Neonatal Research Network (NRN) centres included in this study.
See this image and copyright information in PMC

References

    1. Finer N, Carlo A, Walsh MC, et al. SUPPORT study group of the Eunice Kennedy Shriver NICHD Neonatal Research Network. Early CPAP versus surfactant in extremely preterm infants. N Engl J Med. 2010;362:1970–1979. - PMC - PubMed
    1. SUPPORT Study Group of the Eunice Kennedy Shriver NICHD Neonatal Research Network. Carlo WA, Finer NN, et al. Target ranges of oxygen saturation in extremely preterm infants. N Engl J Med. 2010;362:1959–1969. - PMC - PubMed
    1. Finer NN, Carlo WA, Duara S, et al. National Institute of Child Health and Human Development Neonatal Research Network. Delivery room continuous positive airway pressure/positive end-expiratory pressure in extremely low birth weight infants: a feasibility trial. Pediatrics. 2004;114:651–657. - PubMed
    1. LeVan JM, Wyckoff MH, Jaleel MA, et al. Change in care among nonenrolled patients during and after a randomized trial. Pediatrics. 2013;132:e960–e970. - PubMed
    1. Tyson JE, Parikh NA, Langer J, et al. Intensive care for extreme prematurity--moving beyond gestational age. N Engl J Med. 2008;358:1672–1681. - PMC - PubMed

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