NCT00004840

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
996

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 1998

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 1998

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 1998

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

February 24, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 25, 2000

Completed
Last Updated

June 24, 2005

Status Verified

October 1, 1998

First QC Date

February 24, 2000

Last Update Submit

June 23, 2005

Conditions

Respiratory Distress Syndrome

Keywords

cardiovascular and respiratory diseasesneonatal disordersrare diseaserespiratory distress syndrome

Interventions

thyrotropin-releasing hormoneDRUG

Eligibility Criteria

Age20 Years - 36 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
* 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Respiratory Distress SyndromeRespiratory Tract DiseasesInfant, Newborn, DiseasesRare Diseases

Interventions

Thyrotropin-Releasing Hormone

Condition Hierarchy (Ancestors)

Lung DiseasesRespiration DisordersCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

Study Officials

  • Roberta A. Ballard

    Children's Hospital of Philadelphia

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

February 24, 2000

First Posted

February 25, 2000

Study Start

May 1, 1998

Study Completion

June 1, 1998

Last Updated

June 24, 2005

Record last verified: 1998-10