Trial of Maternal Oxygen for Fetal Left Heart Hypoplasia
Public ClinicalTrials.gov record NCT02965638. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Pilot Randomized Controlled Trial of Maternal Oxygen Therapy for Fetal Left Heart Hypoplasia
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02965638
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 12 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 14 Years to 60 Years
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 31, 2015
- Primary completion
- Jun 30, 2027
- Completion
- Jun 30, 2027
- Last update posted
- Aug 13, 2023
2015 – 2027
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Texas Children's Hospital | Houston | Texas | 77030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02965638, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 13, 2023 · Synced Sep 16, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02965638 live on ClinicalTrials.gov.