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NCT02112513 · ClinicalTrials.gov registry record
The Use of Maternal Serum Unconjugated Estriol for Monitoring the Prevention of Neonatal Respiratory Distress Syndrome
A clinical trial of Neonatal Respiratory Distress Syndrome, sponsored by Indiana University.
- Completed
- Registry status
- 160
- Enrollment target
- 2
- Study locations
NCT02112513: Completed study of Neonatal Respiratory Distress Syndrome, sponsored by Indiana University.
NCT02112513 is a study of Neonatal Respiratory Distress Syndrome that has completed, run by Indiana University. The registered enrollment target is 160 participants. The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02112513, a study of Neonatal Respiratory Distress Syndrome, has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- 160 participants
- Enrollment target
- 2
- Study locations
Study Summary
The objective of this project is to evaluate clinical significance of measuring maternal blood estriol levels, after the administration of antenatal corticosteroids to enhance lung maturity. The investigators will test for associations of the change in maternal estriol with the development of respiratory distress syndrome. The investigators are also interested in determining whether salivary estriol is a valid surrogate to estriol blood assays. In addition the investigators will correlate these changes to pharmacokinetic (PK), pharmacodynamics (PD), and pharmacogenetic measures of betamethasone administration and fetal respiratory outcome
Primary Outcome
Respiratory Distress Syndrome is diagnosed clinically, by need for mechanical ventilation and oxygen for at least 48 hours, and the presence of radiologic chest findings.
Conditions Studied
Study Locations (2)
Indiana
- Eskenazi Hospital - Indianapolis
- Methodist Hospital - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2012-11 |
| Est. Completion | 2017-06-30 |
What the finished NCT02112513 record still lists
NCT02112513 is an observational study that tracks outcomes without assigning an intervention. The registered 160 participants enrollment target is mid-sized for trials with a published cap.
The record links to 1 condition, with Neonatal Respiratory Distress Syndrome appearing as the primary indexed condition, and to 0 interventions.
NCT02112513 reports a single indexed study location in Indiana.
Frequently Asked Questions
What is clinical trial NCT02112513 about?
NCT02112513 is a clinical study titled "The Use of Maternal Serum Unconjugated Estriol for Monitoring the Prevention of Neonatal Respiratory Distress Syndrome". The objective of this project is to evaluate clinical significance of measuring maternal blood estriol levels, after the administration of antenatal corticosteroids to enhance lung maturity. The investigators will test for associations of the change in maternal estriol with the development of respir...
What is the current status of trial NCT02112513?
This trial is currently completed. The enrollment target is 160 participants. The study started on 2012-11. Estimated completion is 2017-06-30.
What conditions does trial NCT02112513 study?
This clinical trial studies the following conditions: Neonatal Respiratory Distress Syndrome.
Who is sponsoring clinical trial NCT02112513?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02112513 being conducted?
This trial has 2 study locations across Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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