Hydrocortisone to treat early bronchopulmonary dysplasia in very preterm infants: study protocol for a randomized controlled trial

This study protocol is for a multicenter double-blind randomized controlled trial of low-dose HC in the treatment of early BPD. Early BPD infants will be randomly assigned to the HC treatment group or control group. Infants in the HC group will receive 0.5  mg/kg HC twice a day for 7 days and then 0.5 mg/kg HC once a day for 3 days. The control group will be given the same volume of placebo and no intervention on the basis of routine treatment. The primary outcome is survival without moderate or severe BPD at 36 weeks postmenstrual age. Seco ndary outcomes are the short- and long-term effects on growth, metabolism, neurodevelopment, and other possible complications.DiscussionThis trial will determine the efficacy and safety of low-dose HC administration compared to placebo for the reduction of moderate or severe BPD at 36  weeks postmenstrual age in very preterm infants with early BPD.Trial registrationChina Clinical Trial Registration CenterChiCTR1900021854. Registered on 13 March 2019.
Source: Trials - Category: Research Source Type: clinical trials