Trials / Completed
CompletedNCT00004840
Study of Antenatal Thyrotropin-Releasing Hormone in Women in Premature Labor to Prevent Lung Disease in Preterm Infants
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 996 (planned)
- Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · NIH
- Sex
- Female
- Age
- 20 Years – 36 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | thyrotropin-releasing hormone |
Timeline
- Start date
- 1998-05-01
- Completion
- 1998-06-01
- First posted
- 2000-02-25
- Last updated
- 2005-06-24
Source: ClinicalTrials.gov record NCT00004840. Inclusion in this directory is not an endorsement.