Early Blood Pressure Management in Extremely Premature Infants

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.

Conditions

• Infant, Newborn
• Infant, Low Birth Weight
• Infant, Small for Gestational Age
• Infant, Premature
• Hypotension
• Blood Pressure

Interventions

DRUG

Dopamine

Dopamine

DRUG

Hydrocortisone

Hydrocortisone

DRUG

Infusion Placebo

Dextrose (D5W)

DRUG

Syringe Placebo

Normal saline

Sponsors & Collaborators

• National Center for Research Resources (NCRR)

  collaborator NIH

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  collaborator NIH

• NICHD Neonatal Research Network

  lead NETWORK

Principal Investigators

• Beau J. Batton, MD · Case Western Reserve University, Rainbow Babies and Children's Hospital

• Ronald N. Goldberg, MD · Duke University

• Krisa P. Van Meurs, MD · Stanford University

• Waldemar A Carlo, MD · University of Alabama at Birmingham

• Kristi L. Watterberg, MD · University of New Mexico

• Roger G. Faix, MD · University of Utah

• Abhik Das, PhD · RTI International

• Edward F. Bell, MD · University of Iowa

• Abbot R. Laptook, MD · Brown University

• Barbara J. Stoll, MD · Emory University

• Brenda P. Poindexter, MD MS · Indiana University

• Kurt Schibler, MD · Children's Hospital Medical Center, Cincinnati

• Kathleen A. Kennedy, MD MPH · The University of Texas Health Science Center, Houston

• Pablo J. Sanchez, MD · University of Texas

• Seetha Shankaran, MD · Wayne State University

• Richard A. Ehrenkranz, MD · Yale University

• Ivan D. Franz III, MD · Tufts University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

FACTORIAL

Eligibility

Max Age

24 Hours

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-07-31

Primary Completion

2010-12-31

Completion

2011-12-31

Countries

• United States

Study Locations