Hydrocortisone does not help pre-term infants

Hydrocortisone treatment in pre-term infants, starting on post-natal day 14 to 28, did not result in substantially higher survival without moderate or severe bronchopulmonary dysplasia (BPD) than placebo, according to the results of a randomised trial.

Prof. Namasivayam Ambalavanan (University of Alabama, AL, USA) introduced the rationale for the study by stating that BPD is a prevalent complication after an extremely pre-term birth (<30 weeks gestation), which may partially be attributable to inflammation as a result of mechanical ventilation. It is unknown whether hydrocortisone treatment after the first post-natal week might be able to improve survival without BPD [1]. To that end, researchers determined the efficacy of hydrocortisone in facilitating extubation, thereby increasing survival without moderate or severe BPD, by initiating the Hydrocortisone and Extubation study (NCT01353313). The study was also recently published in the New England Journal of Medicine [2].

Infants (n=800) with a gestational age <30 weeks (mean birth weight 715±167 g; mean gestational age 24.9±1.5 weeks) who had been intubated for at least 7 days at 14 to 28 days of life were randomised to receive either hydrocortisone (4 mg/kg body weight/day tapered over a period of 10 days) or placebo. The primary efficacy endpoint was the use of respiratory support at 36 weeks post-menstrual age, or survival without moderate or severe BPD. The primary safety endpoint was survival without moderate or severe neurodevelopmental impairment at 22–26 months adjusted age.

Results were disappointing. At 36 weeks, survival without BPD was reported in 66 of 398 infants (16.6%) in the hydrocortisone arm and in 53 of 402 (13.2%) in the placebo arm (adjusted rate ratio 1.27; 95% CI 0.93–1.74; not significant). For the safety endpoint, there was also no difference observed; survival without moderate or severe neurodevelopmental impairment occurred in 36.9% in the hydrocortisone arm and in 37.3% in the placebo arm at 2 years follow-up (adjusted rate ratio 0.98; 95% CI 0.81–1.18; not significant). Furthermore, although most adverse events occurred at similar rates in both groups, hypertension requiring treatment was more common in the hydrocortisone arm than in the placebo arm (4.3% vs 1.0%).

Enrolled children are being seen at 5–6 years for further follow-up.

1. Ambalavanan N, et al. The effect of hydrocortisone on survival without BPD at 36 weeks and on neurodevelopmental impairment (NDI) at 2 years in intubated infants born <30 weeks GA. Session A2, ATS International Conference 2022, San Francisco, CA, USA, 13–18 May.


2. Watterberg KL, et al. N Engl J Med. 2022 Mar 24;386(12):1121–1131.

 

 

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Posted on 17 May, 2022