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Neonatal Neurobehavioral Scale for Congenital Heart Disease

Phase 2 & 3

Recruiting

Research Sponsored by University of Utah

Eligibility Criteria Checklist

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

Must have

Pregnant women 18 years of age and over with a singleton fetus with known or suspected congenital heart disease anticipated to need intervention or surgery within 30 days of birth.

Be younger than 65 years old

Must not have

Known fetal chromosomal or genetic abnormalities

Timeline

Screening 3 weeks

Treatment Varies

Follow Up <=30 days of life

Awards & highlights

No Placebo-Only Group

Summary

This trial investigates how factors like CCHD, the mother-fetus environment, and social determinants of health affect a baby's brain development.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this study uses non-invasive neurobehavioral assessments of newborns rather than medical treatments, it does not involve typical side effects associated with drug trials.

Eligibility Criteria

Inclusion Criteria

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ <=30 days of life

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~<=30 days of life

This trial's timeline: 3 weeks for screening, Varies for treatment, and <=30 days of life for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Baseline MCA-PI and change in MCA-PI with Maternal Hyperoxia

Pre-operative Neonatal Network Neurobehavioral Scale (NNNS) attention scores

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 2Eligibility criteria met