Abstract
Background: Lung inflammation and early adrenal insufficiency are major risk factors of BPD in very low birth weight infants. Early low-dose hydrocortisone treatment may effectively prevent BPD with fewer side effects than early dexamethasone (Pediatrics. 1999;104:1258).
Objectives: To study whether a low-dose hydrocortisone (HC) prevents BPD without acute side effects, and to evaluate serum cortisol levels before and after the supplementation.
Methods: The study was multicenter, randomized placebo-controlled blinded trial. Infants weighing 501–1250 g with gestation age <30 weeks and with respiratory failure were eligible before 36 hours of age. HC or placebo was given for 10 days as follows: HC 2.0 mg/kg/d for 2 days, 1.5 mg/kg/d for 2 days and 0.75 mg/kg/d for 6 days. ACTH test was done at the onset of study and one day after the intervention (Synacthen dose 0.1 ug/kg: serum cortisol levels evaluated before and at 30 min). Primary outcome was survival without BPD at the age of 36 gestational weeks.
Results: The study was discontinued after 51 infants were enrolled as a consequence of increased risk of gastrointestinal (GI) perforations in the HC group (17% vs. 0%, p=0.04). Survival without BPD tended to be higher (55% vs. 45%, OR 1.76, 95% CI 0.52–5.91) and patent ductus arteriosus significantly decreased in the HC group (40% vs. 73%, OR 0.25, 95% CI 0.08–0.80). There were no differences between the study groups in the growth pattern until 36 weeks of gestation. The subgroup of infants with normal ACTH response (delta cortisol >100 nmol/l) at the onset of the study had high risk of GI-perforations during HC (3/8 vs. 0/9, p=0.04). In this subgroup there was no difference in the incidence of BPD between the HC and placebo groups (2/8 vs. 2/9 OR 1.17, 95% CI 0.12–10.99). Among infants with impaired adrenal function (delta cortisol < 100 nmol/l) at birth, HC appeared to decrease the odds of BPD (2/10 vs. 6/9, OR 0.13, 95% CI 0.02–0.99). There were no GI-perforations in this subgroup.
Conclusion: Early low-dose hydrocortisone increases the risk of gastrointestinal perforations among VLBW infants who respond normally to ACTH at birth. The subgroup of infants with impaired early adrenal function benefited from HC treatment without GI-perforations. Further studies are required to define the indications of hydrocortisone for prevention of BPD.
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Peltoniemi, O., Kari, A., Heinonen, K. et al. 209 Randomized, Controlled Trial on Early Low-Dose Hydrocortisone Treatment for Prevention of Bronchopulmonary Dysplasia (BPD). Pediatr Res 56, 499 (2004). https://doi.org/10.1203/00006450-200409000-00232
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DOI: https://doi.org/10.1203/00006450-200409000-00232
