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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00004840

Enrollment

996

Registered

2000-02-25

Start date

1998-05-31

Completion date

1998-06-30

Last updated

2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Distress Syndrome

Keywords

cardiovascular and respiratory diseases, neonatal disorders, rare disease, respiratory distress syndrome

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.

Interventions

DRUGthyrotropin-releasing hormone

Study design

Allocation

RANDOMIZED

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 36 Years

Healthy volunteers

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026