Fetal Cerebrovascular Autoregulation in Congenital Heart Disease and Association With Neonatal Neurobehavior

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexFemale
Age0-52
SponsorUniversity of Utah

About this trial

Determine 1) the impact of abnormal fetal cerebrovascular physiology with neurodevelopmental delay (ND) outcomes and 2) how this relationship is modified by patient and environmental factors such as chronic congenital heart disease (CCHD) lesion, maternal-fetal environment, and social determinants of heath (SDOH) in a diverse population using a multicenter design.

Pregnant women will be approached during one of their fetal cardiology clinic visits.

Eligibility criteria

Qualifiers

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.

Disqualifiers

Known fetal chromosomal or genetic abnormalities

Multiple gestation pregnancy

Fetal extra-cardiac anomalies

Trial design

Treatments tested in this trial

  • Single Arm
  • Neonatal Neurobehavioral Scale

Treatment groups

150 Participants
are divided into 1 treatment group

Sponsors and collaborators

University of Utah

Lead sponsor

Primary Children's Hospital

Collaborator

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator