At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Early Blood Pressure Management in Extremely Preterm Infants Feasibility Pilot Study
In Brief
A Phase 1 clinical trial evaluating Dopamine, Hydrocortisone, and 2 other interventions for Infant, Newborn and 5 related conditions. Completed, enrolled 10 participants across 17 sites.
Detailed Summary
This trial tests the feasibility of enrolling 60 extremely preterm infants in a randomized, double-blinded study of blood pressure management within 12 months. Eligible infants will receive an infusion drug (dopamine or a dextrose placebo) and a syringe drug (hydrocortisone or a normal saline placebo). Enrolled infants will be randomized to receive one of the following drug pairs: * dopamine and hydrocortisone * dopamine and normal saline * dextrose and hydrocortisone * dextrose and normal saline. In addition to the intervention above, the NRN is conducting a 6-month time-limited prospective observational study of all infants born at an NRN center between 23 and 26 weeks gestational age. All clinical decisions made for these babies will be at the discretion of the attending neonatologist/infant care team according to standard practice at each institution. Data on blood pressure management in the first 24 postnatal hours collected for each infant.
Study Details
Timeline
Interventions
Dopamine
Hydrocortisone
Dextrose (D5W)
Normal saline