Early Blood Pressure Management in Extremely Premature Infants
Status:
Completed
Trial end date:
2011-12-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 1
Details
Lead Sponsor:
NICHD Neonatal Research Network
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) National Center for Research Resources (NCRR)