Hydrocortisone to Improve Survival without Bronchopulmonary Dysplasia.
Watterberg. Kristi L KL; Walsh. Michele C MC; Li. Lei L; Chawla. Sanjay S; D'Angio. Carl T CT; Goldberg. Ronald N RN; Hintz. Susan R SR; Laughon. Matthew M MM; Yoder. Bradley A BA; Kennedy. Kathleen A KA; McDavid. Georgia E GE; Backstrom-Lacy. Conra C; Das. Abhik A; Crawford. Margaret M MM; Keszler. Martin M; Sokol. Gregory M GM; Poindexter. Brenda B BB; Ambalavanan. Namasivayam N; Hibbs. Anna Maria AM; Truog. William E WE; Schmidt. Barbara B; Wyckoff. Myra H MH; Khan. Amir M AM; Garg. Meena M; Chess. Patricia R PR; Reynolds. Anne M AM; Moallem. Mohannad M; Bell. Edward F EF; Meyer. Lauritz R LR; Patel. Ravi M RM; Van Meurs. Krisa P KP; Cotten. C Michael CM; McGowan. Elisabeth C EC; Hines. Abbey C AC; Merhar. Stephanie S; Peralta-Carcelen. Myriam M; Wilson-Costello. Deanne E DE; Kilbride. Howard W HW; DeMauro. Sara B SB; Heyne. Roy J RJ; Mosquera. Ricardo A RA; Natarajan. Girija G; Purdy. Isabell B IB; Lowe. Jean R JR; Maitre. Nathalie L NL; Harmon. Heidi M HM; Hogden. Laurie A LA; Adams-Chapman. Ira I; Winter. Sarah S; Malcolm. William F WF; Higgins. Rosemary D RD
Key Findings
- Hydrocortisone did not significantly increase survival without moderate or severe bronchopulmonary dysplasia (16.6% vs 13.2%, not statistically significant).
- No meaningful difference in survival without moderate or severe neurodevelopmental impairment between hydrocortisone and placebo groups (36.9% vs 37.3%).
- Treated hypertension was more common with hydrocortisone (4.3% vs 1.0%).
Practical Outcomes
- The trial shows hydrocortisone given to preterm infants after the second week offers no clear benefit for lung or brain health and may raise blood pressure risk. This information isn’t actionable for adult health optimization or longevity protocols, so it’s not recommended for biohacking use.
Summary
A study gave hydrocortisone to very premature babies to see if it would help them survive without lung disease or brain problems. The drug didn’t meaningfully improve survival or reduce lung issues, and it didn’t change brain outcomes either, but it did raise the chance of high blood pressure. For most people, especially those looking to boost health or performance, this isn’t a useful or relevant finding.
Abstract
Bronchopulmonary dysplasia is a prevalent complication after extremely preterm birth. Inflammation with mechanical ventilation may contribute to its development. Whether hydrocortisone treatment after the second postnatal week can improve survival without bronchopulmonary dysplasia and without adverse neurodevelopmental effects is unknown. We conducted a trial involving infants who had a gestational age of less than 30 weeks and who had been intubated for at least 7 days at 14 to 28 days. Infants were randomly assigned to receive either hydrocortisone (4 mg per kilogram of body weight per day tapered over a period of 10 days) or placebo. Mandatory extubation thresholds were specified. The primary efficacy outcome was survival without moderate or severe bronchopulmonary dysplasia at 36 weeks of postmenstrual age, and the primary safety outcome was survival without moderate or severe neurodevelopmental impairment at 22 to 26 months of corrected age. We enrolled 800 infants (mean [±SD] birth weight, 715±167 g; mean gestational age, 24.9±1.5 weeks). Survival without moderate or severe bronchopulmonary dysplasia at 36 weeks occurred in 66 of 398 infants (16.6%) in the hydrocortisone group and in 53 of 402 (13.2%) in the placebo group (adjusted rate ratio, 1.27; 95% confidence interval [CI], 0.93 to 1.74). Two-year outcomes were known for 91.0% of the infants. Survival without moderate or severe neurodevelopmental impairment occurred in 132 of 358 infants (36.9%) in the hydrocortisone group and in 134 of 359 (37.3%) in the placebo group (adjusted rate ratio, 0.98; 95% CI, 0.81 to 1.18). Hypertension that was treated with medication occurred more frequently with hydrocortisone than with placebo (4.3% vs. 1.0%). Other adverse events were similar in the two groups. In this trial involving preterm infants, hydrocortisone treatment starting on postnatal day 14 to 28 did not result in substantially higher survival without moderate or severe bronchopulmonary dysplasia than placebo. Survival without moderate or severe neurodevelopmental impairment did not differ substantially between the two groups. (Funded by the National Institutes of Health; ClinicalTrials.gov number, NCT01353313.).
Study Information
pubmed
2022
2022-03-24T00:00:00.000Z
10.1056/nejmoa2114897