Early Blood Pressure Management in Extremely Premature Infants

Not Recruiting

Trial ID: NCT00874393


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.

Official Title

Early Blood Pressure Management in Extremely Preterm Infants Feasibility Pilot Study

Stanford Investigator(s)


Inclusion Criteria:

   - Inborn infants

   - 23 0/7 to 26 6/7 weeks estimated gestational age

   - Umbilical arterial catheter in place at study entry

   - <= 24 hours of age

Exclusion Criteria:

   - Terminally ill infants

   - Infants that have received (prior to enrollment): >20 ml/kg in fluid boluses,
   indomethacin, or ibuprofen

   - Infants with major congenital anomalies


drug: Hydrocortisone

drug: Infusion Placebo

drug: Syringe Placebo

drug: dopamine

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
M Bethany Ball