Completed

Antenatal Thyrotropin-Releasing Hormone for Lung Disease Prevention in Preterm Infants

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

thyrotropin-releasing hormone

Drug
Who is being recruted

Lung Diseases+7

+ Congenital, Hereditary, and Neonatal Diseases and Abnormalities

+ Pathologic Processes

From 20 to 36 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: May 1998
See protocol details

Summary

Principal SponsorEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 1998

Actual date on which the first participant was enrolled.

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.

NCT00004840
Principal SponsorEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

996 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 20 to 36 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Lung DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPathologic ProcessesRespiration DisordersPathological Conditions, Signs and SymptomsDisease AttributesInfant, Newborn, DiseasesRespiratory Distress SyndromeRespiratory Tract DiseasesRare Diseases

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has no location dataSave this study to your profile to know when the location data is available.
CompletedNo study centers