Single Arm for Congenital Heart Disease Complex
This trial investigates how factors like CCHD, the mother-fetus environment, and social determinants of health affect a baby's brain development.
- Congenital Heart Disease Complex
- Congenital Heart Disease
- Neurodevelopmental Disorders
2 Primary · 0 Secondary · Reporting Duration: <=30 days of life
1 Treatment Group
1 of 1
150 Total Participants · 1 Treatment Group
Primary Treatment: Single Arm · No Placebo Group · Phase 2 & 3
Who is running the clinical trial?
Age No minimum age - 52 · Female Participants · 1 Total Inclusion CriteriaMark “Yes” if the following statements are true for you:
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- Peyvandi S, Xu D, Wang Y, Hogan W, Moon-Grady A, Barkovich AJ, Glenn O, McQuillen P, Liu J. Fetal Cerebral Oxygenation Is Impaired in Congenital Heart Disease and Shows Variable Response to Maternal Hyperoxia. J Am Heart Assoc. 2021 Jan 5;10(1):e018777. doi: 10.1161/JAHA.120.018777. Epub 2020 Dec 21.
- Dimitropoulos A, McQuillen PS, Sethi V, Moosa A, Chau V, Xu D, Brant R, Azakie A, Campbell A, Barkovich AJ, Poskitt KJ, Miller SP. Brain injury and development in newborns with critical congenital heart disease. Neurology. 2013 Jul 16;81(3):241-8. doi: 10.1212/WNL.0b013e31829bfdcf. Epub 2013 Jun 14.
- Vesoulis ZA, Mathur AM. Cerebral Autoregulation, Brain Injury, and the Transitioning Premature Infant. Front Pediatr. 2017 Apr 3;5:64. doi: 10.3389/fped.2017.00064. eCollection 2017.
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- 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.
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
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
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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