Back to resultsPhase III Randomized, Double-Blind, Placebo-Controlled Study of Antenatal Thyrotropin-Releasing Hormone in Pregnant Women With Threatened Premature Delivery
Primary Purpose
Respiratory Distress Syndrome
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
betamethasone
dexamethasone
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
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Threatened premature delivery at 24 to 30 weeks gestation, i.e.: Premature labor Premature rupture of membranes Elective premature delivery medically indicated Fetal lung maturity immature or unknown --Prior/Concurrent Therapy-- No more than 72 hours since any initial corticosteroids --Patient Characteristics-- The following complications exclude: Fetal distress Amnionitis Severe maternal bleeding uncontrolled with transfusion or volume replacement Fetal or maternal heart disease Significant fetal blood loss Maternal blood pressure 140/90 mm Hg or higher with or without treatment Maternal hyperthyroidism Maternal hyperprolactinemic condition Significant fetal anomaly Multiple gestation with demise of 1 or more fetuses Nonimmune hydrops No participation in other clinical research projects
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00004778
First Posted
February 24, 2000
Last Updated
June 23, 2005
Sponsor
National Center for Research Resources (NCRR)
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Children's Hospital of Philadelphia
1. Study Identification
Unique Protocol Identification Number
NCT00004778
Brief Title
Phase III Randomized, Double-Blind, Placebo-Controlled Study of Antenatal Thyrotropin-Releasing Hormone in Pregnant Women With Threatened Premature Delivery
Study Type
Interventional
2. Study Status
Record Verification Date
December 2001
Overall Recruitment Status
Completed
Study Start Date
August 1993 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Center for Research Resources (NCRR)
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Children's Hospital of Philadelphia
4. Oversight
5. Study Description
Brief 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.
Detailed Description
PROTOCOL OUTLINE: This is a randomized, double-blind study. Participants are stratified by participating institution.
Participants are randomly assigned to 1 of 2 treatment groups. The first group is treated with intravenous thyrotropin-releasing hormone (TRH) and intramuscular injections of betamethasone or dexamethasone. The second group receives a placebo in place of TRH.
Postnatal therapy with surfactants, prophylactic steroids, and indomethacin is allowed.
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
Phase 3
Masking
Double
Allocation
Randomized
Enrollment
1090 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
betamethasone
Intervention Type
Drug
Intervention Name(s)
dexamethasone
Intervention Type
Drug
Intervention Name(s)
thyrotropin-releasing hormone
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
0 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics-- Threatened premature delivery at 24 to 30 weeks gestation, i.e.: Premature labor Premature rupture of membranes Elective premature delivery medically indicated Fetal lung maturity immature or unknown --Prior/Concurrent Therapy-- No more than 72 hours since any initial corticosteroids --Patient Characteristics-- The following complications exclude: Fetal distress Amnionitis Severe maternal bleeding uncontrolled with transfusion or volume replacement Fetal or maternal heart disease Significant fetal blood loss Maternal blood pressure 140/90 mm Hg or higher with or without treatment Maternal hyperthyroidism Maternal hyperprolactinemic condition Significant fetal anomaly Multiple gestation with demise of 1 or more fetuses Nonimmune hydrops No participation in other clinical research projects
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
Phase III Randomized, Double-Blind, Placebo-Controlled Study of Antenatal Thyrotropin-Releasing Hormone in Pregnant Women With Threatened Premature Delivery
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