RCTs of Early Hydrocortisone to Prevent BPD
| Study, No. of Centers . | n . | Population: Mechanically Ventilated Infants . | Hydrocortisone Dosing Regimen . | Rate of Survival Without BPDa HC vs Placebo, % . |
|---|---|---|---|---|
| Watterberg et al,38 2 centers | 40 | 500–999 g BW; <48 h postnatal age | 0.5 mg/kg every 12 h for 9 d | 60 vs 35(P = .04) |
| 0.25 mg/kg every 12 h for 3 d | ||||
| Watterberg et al,39 9 centers | 360b | 500–999 g BW; <48 h postnatal age | 0.5 mg/kg every 12 h for 12 d | 35 vs 34(aORc: 1.20 [95% CI: 0.72–1.99]) |
| 0.25 mg/kg every 12 h for 3 d | ||||
| Peltoniemi et al,40 3 centers | 51b | 501–1250 g BW; <36 h postnatal age | 2.0 mg/kg per d tapered to 0.75 mg/kg per d over 10 d | 64 vs 46(OR: 1.48 [95% CI: 0.49–4.48]) |
| Bonsante et al,41 2 centers | 50b | 500–1249 g BW; <48 h postnatal age | 0.5 mg/kg every 12 h for 9 d; 0.25 mg/kg every 12 h for 3 d | 64 vs 32(P < .05) |
| Total | 601 | — | — | — |
| Study, No. of Centers . | n . | Population: Mechanically Ventilated Infants . | Hydrocortisone Dosing Regimen . | Rate of Survival Without BPDa HC vs Placebo, % . |
|---|---|---|---|---|
| Watterberg et al,38 2 centers | 40 | 500–999 g BW; <48 h postnatal age | 0.5 mg/kg every 12 h for 9 d | 60 vs 35(P = .04) |
| 0.25 mg/kg every 12 h for 3 d | ||||
| Watterberg et al,39 9 centers | 360b | 500–999 g BW; <48 h postnatal age | 0.5 mg/kg every 12 h for 12 d | 35 vs 34(aORc: 1.20 [95% CI: 0.72–1.99]) |
| 0.25 mg/kg every 12 h for 3 d | ||||
| Peltoniemi et al,40 3 centers | 51b | 501–1250 g BW; <36 h postnatal age | 2.0 mg/kg per d tapered to 0.75 mg/kg per d over 10 d | 64 vs 46(OR: 1.48 [95% CI: 0.49–4.48]) |
| Bonsante et al,41 2 centers | 50b | 500–1249 g BW; <48 h postnatal age | 0.5 mg/kg every 12 h for 9 d; 0.25 mg/kg every 12 h for 3 d | 64 vs 32(P < .05) |
| Total | 601 | — | — | — |
BW indicates birth weight; aOR, adjusted odds ratio; OR, odds ratio; CI, confidence interval.
BPD was defined as receiving supplemental oxygen at 36 weeks' postmenstrual age.
Study enrollment was terminated early because of concern for spontaneous gastrointestinal perforation.
Adjusted for center, birth weight, risk factors (gender, “outborn” [infants who were born at an outlying institution and transported into the study center], white race, vaginal delivery, no prenatal steroids, hydrocortisone, and/or vasopressor support at study entry).