Hydrocortisone for BPD

Summary

The Hydrocortisone and Extubation study will test the safety and efficacy of a 10 day course of hydrocortisone for infants who are less than 30 weeks estimated gestational age and who are intubated at 14-28 days of life. Infants will be randomized to receive hydrocortisone or placebo. This study will determine if hydrocortisone improves infants'survival without moderate or severe BPD and will be associated with improvement in survival without moderate or severe neurodevelopmental impairment at 22 - 26 months corrected age.

Timeline

Start

2011-08-11

Primary completion

2020-09-21

Completion

2024-09-12

Publications

• DeMauro SB, Kirpalani H, Hintz S, Watterberg KL, Watson V, Lowe J, Shankaran S, Chawla S, Vohr B, Msall ME, D'Angio CT, Yoder BA, Lai K, Winter S, Colaizy TT, Merhar SL, Ziolkowski K, Bann CM, Trotta M, Newman JE, Walsh MC, Higgins RD, Cahill TE, Duncan AF, Wilson-Costello DE, Peralta-Carcelen M, Arnold H, Mosquera RA, Heyne RJ, Fuller J, McGowan EC, Cavanaugh B, Harmon HM, Maitre NL, Neel ML, Van Meurs KP, Richards LA, Kilbride HW, Hines AC, Natarajan G, Trembath A, Benninger KL, Kesavan K, Malcolm WF, Zanger D, Reynolds AM, Carlson M, Das A; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Hydrocortisone in Preterm Infants and School-Age Functional Outcomes: Follow-Up of a Randomized Clinical Trial. JAMA Pediatr. 2026 Feb 1;180(2):134-143. doi: 10.1001/jamapediatrics.2025.4801.
• Sankar MN, Chock V, Myers F, Davis AS, McDonald S, Rysavy MA, Laughon M, Bhombal S, Van Meurs KP, Das A, Benitz WE, Watterberg K; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Patent Ductus Arteriosus, Hydrocortisone, and Outcome among Infants Born Extremely Preterm: Secondary Analysis of the Hydrocortisone Trial. J Pediatr. 2025 Jun;281:114535. doi: 10.1016/j.jpeds.2025.114535. Epub 2025 Mar 14.
• DeMauro SB, Kirpalani H, Ziolkowski K, Hintz S, Watterberg K, Lowe J, Shankaran S, Chawla S, Vohr B, Msall M, D'Angio C, Yoder BA, Lai K, Winter S, Colaizy T, Merhar S, Bann CM, Trotta M, Newman J, Natarajan A, Das A. The HYdrocortisone for Bronchopulmonary Dysplasia Respiratory and Developmental (HYBRiD) outcomes study: protocol for a longitudinal cohort study. BMC Pediatr. 2024 Nov 14;24(1):737. doi: 10.1186/s12887-024-05198-9.
• Gentle SJ, Rysavy MA, Li L, Laughon MM, Patel RM, Jensen EA, Hintz S, Ambalavanan N, Carlo WA, Watterberg K; National Institute of Child Health and Human Development Neonatal Research Network. Heterogeneity of Treatment Effects of Hydrocortisone by Risk of Bronchopulmonary Dysplasia or Death Among Extremely Preterm Infants in the National Institute of Child Health and Human Development Neonatal Research Network Trial: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2023 May 1;6(5):e2315315. doi: 10.1001/jamanetworkopen.2023.15315.
• Watterberg KL, Walsh MC, Li L, Chawla S, D'Angio CT, Goldberg RN, Hintz SR, Laughon MM, Yoder BA, Kennedy KA, McDavid GE, Backstrom-Lacy C, Das A, Crawford MM, Keszler M, Sokol GM, Poindexter BB, Ambalavanan N, Hibbs AM, Truog WE, Schmidt B, Wyckoff MH, Khan AM, Garg M, Chess PR, Reynolds AM, Moallem M, Bell EF, Meyer LR, Patel RM, Van Meurs KP, Cotten CM, McGowan EC, Hines AC, Merhar S, Peralta-Carcelen M, Wilson-Costello DE, Kilbride HW, DeMauro SB, Heyne RJ, Mosquera RA, Natarajan G, Purdy IB, Lowe JR, Maitre NL, Harmon HM, Hogden LA, Adams-Chapman I, Winter S, Malcolm WF, Higgins RD; Eunice Kennedy Shriver NICHD Neonatal Research Network. Hydrocortisone to Improve Survival without Bronchopulmonary Dysplasia. N Engl J Med. 2022 Mar 24;386(12):1121-1131. doi: 10.1056/NEJMoa2114897.

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Indications