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Randomized Trial of Hydrocortisone in Very Preterm High-Risk Infants

NCT00167544 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2013-08-30

Study results available
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Summary

The purpose of this study is to determine whether treatment of very preterm infants at high-risk for lung and brain injury with low dose hydrocortisone results in improved pulmonary and neurologic outcomes.

Conditions

  • Bronchopulmonary Dysplasia
  • Encephalomalacia
  • Premature Birth

Interventions

DRUG

Hydrocortisone

Hydrocortisone 3 mg/kg/d divided q 12h IV/PO tapered over 7 days

DRUG

Placebo

Saline

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • Nationwide Children's Hospital

    lead OTHER

Principal Investigators

  • Nehal A. Parikh, D.O., M.S. · The Research Institute at Nationwide Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Week
Max Age
3 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-11-30
Primary Completion
2009-01-31
Completion
2012-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00167544 on ClinicalTrials.gov