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Maternal Oxygen for Fetal Left Heart Hypoplasia (P-RCT-MHO Trial)

N/A

Waitlist Available

Led By Shaine A Morris, MD, MPH

Research Sponsored by Shaine Morris

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Flow across the atrial septum either bidirectional or left to right

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 6 and 12 months

Awards & highlights

P-RCT-MHO Trial Summary

This trial is examining if maternal hyperoxygenation is an effective treatment for fetal left heart hypoplasia by measuring how well a baby's heart valves and their surrounding tissue are growing and functioning.

Who is the study for?

This trial is for pregnant women whose fetuses have a heart condition called left heart hypoplasia and are likely to need neonatal intervention. Eligible participants should have specific echocardiography findings but no growth restrictions, multiple gestations, severe fetal conditions, or maternal health issues that could affect the fetus's blood flow.Check my eligibility

What is being tested?

The study tests if breathing extra oxygen (hyperoxygenation) can help babies with underdeveloped hearts grow better before birth compared to regular air. It checks heart valve development and brain growth through ultrasounds and MRIs before and after birth. Initially randomized, it's now open label due to low participation.See study design

What are the potential side effects?

While not explicitly stated in the provided information, potential side effects of maternal hyperoxygenation may include dry throat or mild lung irritation for the mother; however, these are generally minimal as oxygen therapy is commonly used in medical settings.

P-RCT-MHO Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

Blood flows in both directions or from left to right in my heart's upper chambers.

P-RCT-MHO Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 6 and 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 6 and 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 6 and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Fetal aortic valve growth

Fetal mitral valve growth

Secondary outcome measures

Brain maturation score by cerebral magnetic resonance imaging

Change in measured parameters on fetal neurosonography and fetal brain MRI

Neurodevelopmental assessments

+1 more

P-RCT-MHO Trial Design

2Treatment groups

Active Control

Group I: Oxygen GroupActive Control1 Intervention

The mothers will be asked to be on 4 liter of oxygen through nasal cannula up to 24 hours a day. The subjects will be blinded to their treatment.

Group II: Control GroupActive Control1 Intervention

These mothers will not undergo CMH therapy

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Shaine MorrisLead Sponsor

Shaine A Morris, MD, MPHPrincipal InvestigatorBaylor College of Medicine

2 Previous Clinical Trials

90 Total Patients Enrolled

Media Library

Oxygen (Other) Clinical Trial Eligibility Overview. Trial Name: NCT02965638 — N/A

Left Heart Hypoplasia Research Study Groups: Oxygen Group, Control Group

Left Heart Hypoplasia Clinical Trial 2023: Oxygen Highlights & Side Effects. Trial Name: NCT02965638 — N/A

Oxygen (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02965638 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are being observed in this clinical experiment?

"Affirmative. Data on clinicaltrials.gov indicates that this medical experiment, originally posted in September of 2015, is presently recruiting patients. 12 individuals must be recruited from 1 distinct site to meet the study's criteria."

Answered by AI

What is the primary aim of this scientific experiment?

"This clinical trial will assess Fetal aortic valve growth, Change in measured parameters on fetal neurosonography, Neurodevelopmental assessments, and Brain maturation score by cerebral magnetic resonance imaging from enrollment until delivery as primary outcomes. Secondary endpoints gauge postnatal brain MRI metrics as well as series of neurodevelopmental tests."

Answered by AI

Is there an opportunity to join this medical experiment?

"Eligible for this research are patients with fetal left heart hypoplasia aged between 14 and 60. The medical trial has a goal of enrolling 12 people in total."

Answered by AI

Is enrollment for this experiment still open?

"Affirmative. Clinicaltrials.gov data reveals that recruitment for this medical trial is still active - the study was first launched on September 1st 2015, with its most recent update taking place November 22nd 2021. The research team aims to enrol 12 participants from one site only."

Answered by AI