Am J Perinatol
DOI: 10.1055/s-0043-1776416
Original Article

Intratracheal Instillation of Budesonide–Surfactant for Prevention of Bronchopulmonary Dysplasia in Extremely Premature Infants

1   Department of Pediatrics, Division of Neonatology, University of South Alabama, Mobile, Alabama
,
Michael Zayek
1   Department of Pediatrics, Division of Neonatology, University of South Alabama, Mobile, Alabama
,
Aayushka Gurung
1   Department of Pediatrics, Division of Neonatology, University of South Alabama, Mobile, Alabama
,
Fabien Eyal
1   Department of Pediatrics, Division of Neonatology, University of South Alabama, Mobile, Alabama
› Author Affiliations
Funding None.

Abstract

Objective This study aimed to determine the effect of intratracheal instillation of a budesonide–surfactant combination on the incidence of bronchopulmonary dysplasia (BPD) or death compared with surfactant alone in extremely preterm infants.

Study Design In this retrospective, single-center study, we included extremely preterm infants (<28 weeks' gestation) who received surfactant for respiratory distress in the first 3 days of life. We compared infants who received budesonide–surfactant combination (intervention group: infants born between February 2016 and October 2021) with surfactant alone (control group: infants born from January 2010 through January 2016). The primary outcome was a composite of BPD grade 2 or 3 (as defined by Jensen et al, 2019) or death before 36 weeks' postmenstrual age (PMA).

Results We included 966 extremely preterm infants (528 in the control group and 438 in the intervention group). While the incidence of death/BPD grade 2 or 3 at 36 weeks of PMA was not different between the two groups (66% in the intervention group vs. 63% in the control group; adjusted relative risk [aRR], 0.99; 95% confidence interval [CI], 0.90–1.07; p-value = 0.69), budesonide was associated with a reduction in the primary outcome only in a subgroup of infants with birth weight ≥ 750 grams (36.8 vs. 43.5%, respectively; aRR 0.75; 95% CI, 0.57–0.98). Primary and secondary outcomes did not differ between the two groups within the subgroup of infants weighing <750 grams.

Conclusion In extremely preterm infants, the budesonide–surfactant combination therapy reduced the rates of BPD or death in infants weighing ≥750 grams; however, this beneficial effect was not seen in infants weighing <750 grams. Further investigation of this treatment may be indicated before it is considered a standard approach to management.

Key Points

  • Intratracheal budesonide–surfactant therapy reduces BPD in preterm infants weighing ≥750 grams.

  • Intratracheal budesonide–surfactant therapy does not affect BPD in preterm infants weighing <750 grams.

  • Intratracheal budesonide–surfactant therapy does not affect the mortality rate in preterm infants.

Authors' Contributions

K.D. was responsible for writing the protocol, designing the study, extracting and analyzing the data, interpreting results, drafting the initial manuscript, and reviewing and revising the manuscript. A.G. was responsible for extracting the data and editing the manuscript. M.Z. contributed to writing the protocol, designing the study, extracting and analyzing the data, interpreting results, and providing feedback on the manuscript. FE contributed to analyzing the data, interpreting results, and providing feedback on the manuscript.


Ethics Declarations

This study protocol was reviewed and approved by the University of South Alabama Institutional Review Board (IRB number: 22-125). This study was approved for waiver of Health Insurance Portability and Accountability Act (HIPAA) authorization, and the University of South Alabama Institutional Review Board waived the need for consent. This study was conducted according to the Declaration of Helsinki.


Availability of Data and Materials

The datasets used and analyzed during the current study are available from the corresponding author upon reasonable request.




Publication History

Received: 16 June 2023

Accepted: 10 October 2023

Article published online:
01 November 2023

© 2023. Thieme. All rights reserved.

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