Hydrocortisone for Term Hypotension

Summary

This trial will evaluate the effects of a 7-day course of hydrocortisone therapy on short-term morbidity, cardiovascular function, long-term neurodevelopment, and mortality in critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as defined by a need for inotrope therapy in the first 72 hours of age.

Conditions

• Infant, Newborn, Diseases
• Cardiovascular Insufficiency

Interventions

DRUG

Hydrocortisone

• 7 day course of hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line). 1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose

DRUG

Placebo

7 days of intravenous or intramuscular placebo (normal saline in equal volume) 1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose

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

• 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

• Ron N Goldberg, MD · Duke University

• Barbara J Stoll, MD · Emory University

• Brenda B Poindexter, MD, MS · Indiana University

• Abhik Das, PhD · RTI International

• Krisa P Van Meurs, MD · Stanford University

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

• Waldemar Carlo, MD · University of Alabama at Birmingham

• Edward F Bell, MD · Michele C Walsh, MD Study Principal Investigator Case Western Reserve University, Rainbow Babies and Children's Hospital Seetha Shankaran, MD Study Principal Investigator Wayne State University Abbot R Laptook, MD Study Principal Investigator Brown Un

• Erika Fernandez, MD · University of New Mexico

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

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

• Barbara Schmidt, MD · University of Pennsylvania

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

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

• Leif Nelin, MD · Research Institute at Nationwide Children's Hospital

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

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

34 Weeks

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-06-19

Primary Completion

2018-03-20

Completion

2018-03-20

Countries

• United States

Study Locations