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BMC Pediatrics
Published in: BMC Pediatrics 1/2018

Open Access 01-12-2018 | Research article

Inhaled corticosteroids in ventilated preterm neonates: a non-randomized dose-ranging study

Authors: Kamini Raghuram, Michael Dunn, Krista Jangaard, Maureen Reilly, Elizabeth Asztalos, Edmond Kelly, Michael Vincer, Vibhuti Shah

Published in: BMC Pediatrics | Issue 1/2018

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Abstract

Background

Inhaled corticosteroids (ICS) offer targeted treatment for bronchopulmonary dysplasia (BPD) with minimal systemic effects compared to systemic steroids. However, dosing of ICS in the management of infants at high-risk of developing BPD is not well established. The objective of this study was to determine an effective dose of ICS for the treatment of ventilator-dependent infants to facilitate extubation or reduce fractional inspired oxygen concentration.

Methods

Forty-one infants born at < 32 weeks gestational age (GA) or < 1250 g who were ventilator-dependent at 10–28 days postnatal age were included. A non-randomized dose-ranging trial was performed using aerosolized inhaled beclomethasone with hydrofluoralkane propellant (HFA-BDP). Four dosing groups (200, 400, 600 and 800 μg twice daily for 1 week) with 11, 11, 10 and 9 infants in each group, respectively, were studied. The primary outcome was therapeutic efficacy (successful extubation or reduction in FiO2 of > 75% from baseline) in ≥60% of infants in the group. Oxygen requirements, complications and long-term neurodevelopmental outcomes were also assessed.

Results

The median age at enrollment was 22 (10–28) postnatal days. The primary outcome, therapeutic efficacy as defined above, was not achieved in any group. However, there was a significant reduction in post-treatment FiO2 at a dose of 800 μg bid. No obvious trends were seen in long-term neurodevelopmental outcomes.

Conclusions

Therapeutic efficacy was not achieved with all studied doses of ICS. A significant reduction in oxygen requirements was noted in ventilator-dependent preterm infants at 10–28 days of age when given 800 μg of HFA-BDP bid. Larger randomized trials of ICS are required to determine efficacy for the management of infants at high-risk for development of BPD.

Trial registration

This clinical trial was registered retrospectively on clinicaltrials.gov. The registration number is NCT03503994.
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Metadata
Title
Inhaled corticosteroids in ventilated preterm neonates: a non-randomized dose-ranging study
Authors
Kamini Raghuram
Michael Dunn
Krista Jangaard
Maureen Reilly
Elizabeth Asztalos
Edmond Kelly
Michael Vincer
Vibhuti Shah
Publication date
01-12-2018
Publisher
BioMed Central
Published in
BMC Pediatrics / Issue 1/2018
Electronic ISSN: 1471-2431
DOI
https://doi.org/10.1186/s12887-018-1134-7

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