Single Arm for Congenital Heart Disease Complex

Phase-Based Progress Estimates
University of California San Francisco, San Francisco, CACongenital Heart Disease Complex+3 MoreNeonatal Neurobehavioral Scale - Procedure
No minimum age - 52
What conditions do you have?

Study Summary

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

Eligible Conditions
  • Congenital Heart Disease Complex
  • Congenital Heart Disease
  • Hypoxia
  • Neurodevelopmental Disorders

Treatment Effectiveness

Study Objectives

2 Primary · 0 Secondary · Reporting Duration: <=30 days of life

Day 30
Baseline MCA-PI and change in MCA-PI with Maternal Hyperoxia
<=30 days of life
Pre-operative Neonatal Network Neurobehavioral Scale (NNNS) attention scores

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

1 Treatment Group

Single Arm
1 of 1

Experimental Treatment

150 Total Participants · 1 Treatment Group

Primary Treatment: Single Arm · No Placebo Group · Phase 2 & 3

Single ArmExperimental Group · 2 Interventions: Neonatal Neurobehavioral Scale, Single Arm · Intervention Types: Procedure, Procedure

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: <=30 days of life

Who is running the clinical trial?

University of UtahLead Sponsor
1,008 Previous Clinical Trials
1,787,232 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,616 Previous Clinical Trials
47,118,046 Total Patients Enrolled
Primary Children's HospitalOTHER
18 Previous Clinical Trials
14,054 Total Patients Enrolled

Eligibility Criteria

Age No minimum age - 52 · Female Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Women aged 18 and over who are pregnant with one baby, suspected or known to have congenital heart disease, and needing attention or surgery within 30 days of delivery.

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

Are there any vacant slots to join this research study?

"According to official records found on, 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." - Anonymous Online Contributor

Unverified Answer

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

"Affirmative. 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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.