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Phase III Randomized, Double-Blind, Placebo-Controlled Study of Antenatal Thyrotropin-Releasing Hormone in Pregnant Women With Threatened Premature Delivery

NCT00004778 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1090

Last updated 2005-06-24

No results posted yet for this study

Summary

OBJECTIVES: I. Evaluate the effect of thyrotropin-releasing hormone (TRH) on the severity of initial lung disease and occurrence of chronic lung disease when given antenatally to women with threatened premature delivery.

II. Evaluate possible mechanisms for the effects of TRH on the severity and incidence of chronic lung disease.

III. Investigate whether a deficiency in endogenous cortisol and/or thyroid hormones after birth influences the severity of lung disease and the development of chronic lung disease.

Conditions

  • Respiratory Distress Syndrome

Interventions

DRUG

betamethasone

DRUG

dexamethasone

DRUG

thyrotropin-releasing hormone

Sponsors & Collaborators

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

    collaborator NIH

  • Children's Hospital of Philadelphia

    collaborator OTHER

  • National Center for Research Resources (NCRR)

    lead NIH

Principal Investigators

  • Roberta A. Ballard · Children's Hospital of Philadelphia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE

Eligibility

Min Age
0 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
1993-08-31

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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 NCT00004778 on ClinicalTrials.gov