Back to resultsStudy of Antenatal Thyrotropin-Releasing Hormone in Women in Premature Labor to Prevent Lung Disease in Preterm Infants
Primary Purpose
Respiratory Distress Syndrome
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
thyrotropin-releasing hormone
Sponsored by
About this trial
This is an interventional treatment trial for Respiratory Distress Syndrome focused on measuring cardiovascular and respiratory diseases, neonatal disorders, rare disease, respiratory distress syndrome
Eligibility 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
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00004840
First Posted
February 24, 2000
Last Updated
June 23, 2005
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborators
Children's Hospital of Philadelphia
1. Study Identification
Unique Protocol Identification Number
NCT00004840
Brief Title
Study of Antenatal Thyrotropin-Releasing Hormone in Women in Premature Labor to Prevent Lung Disease in Preterm Infants
Study Type
Interventional
2. Study Status
Record Verification Date
October 1998
Overall Recruitment Status
Completed
Study Start Date
May 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 1998 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborators
Children's Hospital of Philadelphia
4. Oversight
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Distress Syndrome
Keywords
cardiovascular and respiratory diseases, neonatal disorders, rare disease, respiratory distress syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Masking
Double
Allocation
Randomized
Enrollment
996 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
thyrotropin-releasing hormone
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
36 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roberta A. Ballard
Organizational Affiliation
Children's Hospital of Philadelphia
Official's Role
Study Chair
12. IPD Sharing Statement
Learn more about this trial
Study of Antenatal Thyrotropin-Releasing Hormone in Women in Premature Labor to Prevent Lung Disease in Preterm Infants
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