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NCT02965638 · ClinicalTrials.gov registry record · NA
Trial of Maternal Oxygen for Fetal Left Heart Hypoplasia
A NA study of Fetal Left Heart Hypoplasia, sponsored by Shaine Morris.
- Active
- Registry status
- NA
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT02965638: Active NA study of Fetal Left Heart Hypoplasia, sponsored by Shaine Morris.
NCT02965638 is a NA study of Fetal Left Heart Hypoplasia that is active but no longer recruiting, run by Shaine Morris. The registered enrollment target is 12 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02965638, a NA study of Fetal Left Heart Hypoplasia, is active but no longer recruiting, sponsored by Shaine Morris.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to determine if maternal hyperoxygenation is an effective treatment for fetal left heart hypoplasia versus room air (placebo). This will be determined by measuring how well a baby's heart valves and their surrounding tissue are growing and functioning. In addition the investigators will examine brain growth using fetal ultrasound and MRI, and MRI of the child's brain after they are born to determine if there is greater neonatal brain maturity or mothers receiving oxygen compared to fetuses of mothers not receiving oxygen. Of note, the trial was initially randomized. However, due to low sample size and hesitation about randomization, the trial was converted to an open label study, allowing families opting for oxygen therapy to be in the intervention arm.
Primary Outcome
The rate of growth of the fetal aortic valve using fetal echocardiography during serial echocardiography throughout enrollment during the fetal period
Conditions Studied
Interventions
- OTHER Oxygen
Study Locations (1)
Texas
- Texas Children's Hospital - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2015-09 |
| Est. Completion | 2027-07 |
| Phase | NA |
What the registry record for NCT02965638 still lists
NCT02965638 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Fetal Left Heart Hypoplasia appearing as the primary indexed condition, and to 1 intervention - of which Oxygen is the first listed.
NCT02965638 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT02965638 about?
NCT02965638 is a clinical study titled "Trial of Maternal Oxygen for Fetal Left Heart Hypoplasia". The purpose of this study is to determine if maternal hyperoxygenation is an effective treatment for fetal left heart hypoplasia versus room air (placebo). This will be determined by measuring how well a baby's heart valves and their surrounding tissue are growing and functioning. In addition the i...
What is the current status of trial NCT02965638?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 12 participants. The study started on 2015-09. Estimated completion is 2027-07.
What conditions does trial NCT02965638 study?
This clinical trial studies the following conditions: Fetal Left Heart Hypoplasia.
What interventions are being tested in trial NCT02965638?
The interventions under investigation include: Oxygen (OTHER).
Who is sponsoring clinical trial NCT02965638?
This trial is sponsored by Shaine Morris, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02965638 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02965638's enrollment target sits among peer trials
12 1913th of 2000 higher than 74 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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