Neonatal Neurobehavioral Scale for Congenital Heart Disease

Recruiting in Palo Alto (17 mi)

+4 other locations

Age: < 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Recruiting

Sponsor: University of Utah

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?Determine 1) the impact of abnormal fetal cerebrovascular physiology with neurodevelopmental delay (ND) outcomes and 2) how this relationship is modified by patient and environmental factors such as chronic congenital heart disease (CCHD) lesion, maternal-fetal environment, and social determinants of heath (SDOH) in a diverse population using a multicenter design. Pregnant women will be approached during one of their fetal cardiology clinic visits.

Eligibility Criteria

This trial is for pregnant women over 18 with a single baby diagnosed or suspected to have congenital heart disease requiring intervention within the first month after birth. It's not for those carrying multiple babies, or if there are known genetic abnormalities or extra-cardiac anomalies in the fetus.

Inclusion Criteria

I am pregnant, over 18, and my unborn baby may need heart surgery soon after birth.

Exclusion Criteria

Unborn baby has other body part problems besides the heart.

My unborn baby has been diagnosed with a genetic or chromosomal issue.

Multiple gestation pregnancy

Participant Groups

The study aims to understand how abnormal blood flow in the unborn baby's brain might lead to neurodevelopmental delays and how this is influenced by factors like heart defects, maternal health, and social conditions. It involves using a Neonatal Neurobehavioral Scale on newborns.

1Treatment groups

Experimental Treatment

Group I: Single ArmExperimental Treatment2 Interventions

Maternal Hyperoxia (MH) will be administered to pregnant patients after their standard of care fetal echocardiogram has been performed at their scheduled fetal cardiology visit at ³28 weeks gestation. The evaluation at ³28 weeks was chosen since gestational age impacts both the cardiovascular and cerebrovascular response to MH.31 The evaluation will extend the duration of the visit by approximately 30 minutes but additional evaluations or visits for the study will not be required.