Study of Antenatal Thyrotropin-Releasing Hormone in Women in Premature Labor to Prevent Lung Disease in Preterm Infants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

996 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-05-31

Study Completion Date

1998-06-30

Brief Summary

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OBJECTIVES:

I. Assess the efficacy and safety of antenatal administration of thyrotropin-releasing hormone to women in premature labor to improve pulmonary outcomes in preterm infants.

Detailed Description

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PROTOCOL OUTLINE: This is a randomized, double blind, multicenter study. Patients are randomized to receive antenatal thyrotropin-releasing hormone or placebo.

Patients receive thyrotropin-releasing hormone or placebo intravenously over 20 minutes every 8 hours for 4 doses.

Infants are assessed for survival and chronic lung disease until day 28 after birth, and again at 36 postmenstrual weeks.

Conditions

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Respiratory Distress Syndrome

Keywords

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cardiovascular and respiratory diseases neonatal disorders rare disease respiratory distress syndrome

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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thyrotropin-releasing hormone

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Pregnant women in active labor with 24-29 weeks gestation
* Not eligible if any of the following is present: Bleeding Infection Hypertension (greater than 140/90 mmHg) Fetus with hydrops or life-threatening anomalies One dead fetus in multiple pregnancy

Minimum Eligible Age

20 Years

Maximum Eligible Age

36 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Principal Investigators

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Roberta A. Ballard

Role: STUDY_CHAIR

Children's Hospital of Philadelphia

Other Identifiers

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CHP-5R01HD29201-03

Identifier Type: -

Identifier Source: secondary_id

199/13784