Hydrocortisone for BPD

Summary

The Hydrocortisone and Extubation study will test the safety and efficacy of a 10 day course of hydrocortisone for infants who are less than 30 weeks estimated gestational age and who are intubated at 14-28 days of life. Infants will be randomized to receive hydrocortisone or placebo. This study will determine if hydrocortisone improves infants'survival without moderate or severe BPD and will be associated with improvement in survival without moderate or severe neurodevelopmental impairment at 22 - 26 months corrected age.

Conditions

• Infant, Newborn
• Infant, Small for Gestational Age
• Infant, Very Low Birth Weight
• Infant, Premature
• Bronchopulmonary Dysplasia

Interventions

DRUG

Hydrocortisone

Hydrocortisone sodium succinate for intravenous administration (unpreserved, Solu-Cortef plain, Pfizer®, reconstituted with unpreserved normal saline to avoid exposure to the benzyl alcohol contained in preserved diluents), to be administered either intravenously or orally if no intravenous line is available at the same dose, and tapered as follows: 4mg/kg/day ¸ q 6 hours x 2 days, then 2mg/kg/day ¸ q 6 hours x 3 days; then 1mg/kg/day ¸ q 12 hours x 3 days; then 0.5mg/kg/d as a single dose x 2 days

DRUG

Placebo

Saline placebo to be administered either intravenously or orally if no intravenous line is available, at the same dose, and tapered as follows: 4mg/kg/day ¸ q 6 hours x 2 days, then 2mg/kg/day ¸ q 6 hours x 3 days; then 1mg/kg/day ¸ q 12 hours x 3 days; then 0.5mg/kg/d as a single dose x 2 days

Sponsors & Collaborators

• National Center for Research Resources (NCRR)

  collaborator NIH

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

  collaborator NIH

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• National Center for Advancing Translational Sciences (NCATS)

  collaborator NIH

• NICHD Neonatal Research Network

  lead NETWORK

Principal Investigators

• Michele C Walsh, MD · Case Western Reserve University, Rainbow Babies and Children's Hospital

• Seetha Shankaran, MD · Wayne State University

• Abbot R Laptook, MD · Brown University, Women & Infants Hospital of Rhode Island

• C. Michael Cotten, MD · Duke University

• David Carlton, MD · Emory University

• Greg Sokol, MD · Indiana University

• Abhik Das, PhD · RTI International

• Krisa P Van Meurs, MD · Stanford University

• Brenda P Poindexter, MD · Children's Hospital Medical Center, Cincinnati

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

• Edward F Bell, MD · University of Iowa

• Kristi L Watterberg, MD · University of New Mexico

• Myra Wyckoff, MD · University of Texas, Southwestern Medical Center at Dallas

• Jon E Tyson, MD, MPH · The University of Texas Health Science Center, Houston

• Eric Eichenwald, MD · University of Pennsylvania

• Carl T D'Angio, MD · University of Rochester

• Uday Devaskar, MD · University of California, Los Angeles

• Pablo J Sanchez, MD · Research Institute at Nationwide Children's Hospital

• William Truog, MD · Children's Mercy Hospital Kansas City

• Bradley Yoder, MD · University of Utah

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Max Age

30 Weeks

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-08-11

Primary Completion

2020-09-21

Completion

2024-09-12

FDA Drug

Yes

Countries

• United States

Study Locations