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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up <=30 days of life
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I am pregnant, over 18, and my unborn baby may need heart surgery soon after birth.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Baseline MCA-PI and change in MCA-PI with Maternal Hyperoxia
Pre-operative Neonatal Network Neurobehavioral Scale (NNNS) attention scores

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.

Find a Location

Who is running the clinical trial?

University of UtahLead Sponsor
1,099 Previous Clinical Trials
1,778,572 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,836 Previous Clinical Trials
47,850,745 Total Patients Enrolled
Primary Children's HospitalOTHER
21 Previous Clinical Trials
20,310 Total Patients Enrolled

Media Library

Neonatal Neurobehavioral Scale Clinical Trial Eligibility Overview. Trial Name: NCT05767385 — Phase 2 & 3
Congenital Heart Disease Research Study Groups: Single Arm
Congenital Heart Disease Clinical Trial 2023: Neonatal Neurobehavioral Scale Highlights & Side Effects. Trial Name: NCT05767385 — Phase 2 & 3
Neonatal Neurobehavioral Scale 2023 Treatment Timeline for Medical Study. Trial Name: NCT05767385 — Phase 2 & 3

Frequently Asked Questions

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

To whom is access to this clinical trial open?

"Eligibility for this trial is contingent on being between the ages of 0 and 52, as well as displaying signs of hypoxia. 150 participants in total need to be enrolled."

Answered by AI

Are individuals aged 40 and above being enrolled into this research study?

"As indicated in the eligibility requirements, participants must be between 0 and 52 years of age. There are 173 studies for minors and 358 for those over 65."

Answered by AI

Are there any vacant slots to join this research study?

"According to official records found on clinicaltrials.gov, the search for participants is still ongoing at this time. The trial was initially published on December 17th 2021 and had its last update posted March 1st 2023."

Answered by AI

What is the current cohort size of participants enrolled in this trial?

"Affirmative. Clinicaltrials.gov alludes to this clinical trial's current demands for participants, which commenced on the 17th of December 2021 and was most recently modified on March 1st 2023. The study plan necessitates 150 recruits from 5 different medical centres."

Answered by AI

How many physical sites are currently administering this research project?

"At present, 5 different sites across the US have opened their doors to enrolling patients in this trial. These locations are situated in Washington, Scarborough and Salt Lake City amongst other cities. It is advisable for participants to choose a center closest to them so that travel demands can be minimized if they decide to join the study."

Answered by AI

Who else is applying?

What state do they live in?
Mississippi
What site did they apply to?
University of California San Francisco
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
Fetal Cerebrovascular Autoregulation in Congenital Heart Disease and Association With Neonatal Neurobehavior
Whitnee Hogan, MD (Assistant Professor) 2021. "Fetal Cerebrovascular Autoregulation in Congenital Heart Disease and Association With Neonatal Neurobehavior". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05767385.
All > Heart Disease
~30 spots leftby Dec 2024
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