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Trial of Maternal Oxygen for Fetal Left Heart Hypoplasia

NCT02965638 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2023-08-14

No results posted yet for this 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.

Conditions

  • Fetal Left Heart Hypoplasia

Interventions

OTHER

Oxygen

The intervention arm (Oxygen Group) will receive oxygen via nasal cannula at a rate of 4L of FiO2 93-100% from an oxygen concentrator up to 24 hours daily

Sponsors & Collaborators

  • Shaine Morris

    lead OTHER

Principal Investigators

  • Shaine A Morris, MD, MPH · Baylor College of Medicine

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2027-07-31
Completion
2027-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02965638 on ClinicalTrials.gov