Early Blood Pressure Management in Extremely Premature Infants

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

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)
• Treatments: Cortisol succinate; Dopamine; Dopamine Agents; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate

Criteria

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