Neonatal Neurobehavioral Scale for Congenital Heart Disease

Recruiting at 6 trial locations

Overseen By Lisa M. Hansen, BA

Age: < 65

Sex: Female

Trial Phase: Phase 2 & 3

Sponsor: University of Utah

Disqualifiers: Fetal genetic abnormalities, multiple gestation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how certain factors during pregnancy affect a newborn's brain development, especially in babies with congenital heart disease (a heart condition present at birth). Researchers are exploring how the baby's and mother's health, along with social factors, may influence the baby's development. Participants will receive a special evaluation using the Neonatal Neurobehavioral Scale after a routine heart check-up during pregnancy. Pregnant women expecting a baby with a known or suspected heart condition, who will need treatment soon after birth, may be eligible to join.

As a Phase 2/3 trial, this study measures the treatment's effectiveness in an initial, smaller group and represents the final step before FDA approval. Participants have the opportunity to contribute to significant advancements in prenatal care.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Neonatal Neurobehavioral Scale is safe?

Research has shown that giving extra oxygen to pregnant women is safe for both mothers and their unborn babies. Eight studies have examined this treatment, and none found any safety problems.

One study found that providing oxygen at a rate of 10 to 15 liters per minute for up to 45 minutes was safe for both mother and baby. Additionally, four different studies reported no major negative effects.

Overall, the evidence suggests that extra oxygen is well-tolerated and can be safely used in pregnant women with congenital heart disease. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Neonatal Neurobehavioral Scale for Congenital Heart Disease is unique because it aims to evaluate the effects of Maternal Hyperoxia (MH) on fetal development. Unlike standard care treatments that typically focus on postnatal interventions, this approach involves administering additional oxygen to pregnant mothers during a routine fetal cardiology visit. Researchers are excited about this trial because it explores how MH might improve cardiovascular and cerebrovascular responses in the fetus, potentially leading to better outcomes for babies with congenital heart disease right from the womb. This innovative focus on prenatal intervention could offer new insights into early treatment possibilities, setting it apart from existing options.

What evidence suggests that the Neonatal Neurobehavioral Scale is effective for congenital heart disease?

Research has shown that giving extra oxygen to a mother might help babies with heart problems. Studies indicate that this can improve blood flow to the baby's brain, potentially supporting better brain development and reducing the risk of brain injury. One study found that extra oxygen increased blood flow in the baby's heart and lungs, which is crucial for their health. Some evidence suggests that this treatment can help deliver more oxygen to the baby's brain, potentially enhancing brain development. Overall, the data supports the idea that giving mothers extra oxygen could benefit babies with heart issues during pregnancy. In this trial, researchers will administer maternal hyperoxia to pregnant patients to evaluate its effects on fetal development. ^{1 3 5 6 7}

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Maternal Hyperoxia Treatment

Maternal Hyperoxia (MH) will be administered to pregnant patients after their standard of care fetal echocardiogram at their scheduled fetal cardiology visit at ≥28 weeks gestation.

30 minutes

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, focusing on baseline MCA-PI and change in MCA-PI with Maternal Hyperoxia and pre-operative NNNS attention scores.

4 weeks

No additional visits required

What Are the Treatments Tested in This Trial?

Interventions

• Neonatal Neurobehavioral Scale
• Single Arm

Trial Overview

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.

How Is the Trial Designed?

Group I: Single Arm Experimental Treatment 2 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.

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Primary Children's Hospital

Collaborator

Trials

22

Recruited

15,900+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8429855/

Maternal hyperoxygenation in congenital heart disease - PMC

Based on the current studies, it appears CMH therapy administered early in the third trimester at ~50% FiO2 for at least 9 hours per day may be beneficial for ...

2.

ahajournals.org

ahajournals.org/doi/10.1161/JAHA.120.018777

Fetal Cerebral Oxygenation Is Impaired in Congenital ...

Fetal Cerebral Oxygenation Is Impaired in Congenital Heart Disease and Shows Variable Response to Maternal Hyperoxia.

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03944837

NCT03944837 | Acute Maternal Hyperoxygenation in CHD

This study determines the impact of administering oxygen to mother during the later part of pregnancy on cerebral oxygen delivery in fetuses who were identified ...

4.

onlinelibrary.wiley.com

onlinelibrary.wiley.com/doi/10.1111/echo.13722

Maternal hyperoxygenation: A potential therapy for ...

The current evidence for MH therapy suggests an increase in pulmonary blood flow, pulmonary venous return, ductal flow, and left heart ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6719779/

Cerebrovascular response to maternal hyperoxygenation ...

By increasing cerebral oxygen delivery, maternal hyperoxygenation (MH) might improve brain development and reduce the risk of brain injury in these fetuses.

6.

ahajournals.org

ahajournals.org/doi/10.1161/JAHA.125.042014

Fetal Cerebrovascular Response to Maternal Hyperoxia ...

Neurodevelopmental outcomes are impaired in significant congenital heart disease (CHD) with prenatal origins. The cerebrovascular response ...

7.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/29287137/

A potential therapy for congenital heart disease in the ...

No significant adverse events were reported. Four studies reported increased size of the hypoplastic cardiac structures after MH. Three studies utilized acute ...