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Improving Neurodevelopmental ouTcomes After Prenatal Cannabinoid in uTero Exposure

RecruitingHealthy volunteers welcome

Pilot Feasibility Trial of Improving Neurodevelopmental ouTcomes After Prenatal Cannabinoid in uTero Exposure (INTACT)

Who can join

7 Days · All sexes · Healthy volunteers welcome

Full eligibility criteria
Inclusion Criteria:

Birthing Parent

* Age of majority, as defined by the state of residency
* Cannabinoid use during pregnancy confirmed with self-report
* Have the ability to speak, read, and understand English
* Birthing parent who delivered at one of the hospitals where study team members have clinical privileges to access medical records
* Has parental custody of the infant
* Singleton pregnancy with live birth
* Has an electronic device capable of watching videos and able to stream/download videos for viewing and permitting video conferencing
* Has study access to the internet

Infant

* Term infants at birth (\>37 weeks' gestation)
* Biological child of the birthing parent

Exclusion Criteria:

Birthing Parent

* Other illicit drug use, excluding cannabinoids, during pregnancy (such as heroin or cocaine) per self-reported or toxicology results
* Opiate use (prescribed or unprescribed) per self-report or toxicology results during this pregnancy
* Prolonged hospitalization following delivery longer than 7 days

Infant

* Has major birth defect(s) including physical anomalies including limb malformations/absence of limbs or chromosomal abnormalities
* Diagnosed with neonatal encephalopathy, metabolic disorder, stroke, intracranial hemorrhage, or meningitis during birth hospitalization
* Received any major surgical intervention during the birth hospitalization or required a prolonged birth hospitalization (prolonged hospitalization being any hospitalization longer than 7 days)

About the study

The INTACT trial is a multisite pilot feasibility study aimed at testing the effectiveness of the INTACT Intervention program in improving neurodevelopmental outcomes in infants prenatally exposed to cannabinoids. The trial will enroll 20 birthing parent/infant dyads across three sites and will evaluate feasibility endpoints rather than clinical outcomes. The study duration is 22 months, including study start-up, enrollment and intervention, and data analysis and manuscript preparation.

What is being tested

Sponsor: IDeA States Pediatric Clinical Trials Network · Participants: 20 · Started: Feb 6, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06423664

Locations in the U.S.

New MexicoUniversity of New Mexico Health Sciences Center, Albuquerque
South DakotaAvera Research Institute, Sioux Falls
VermontUniversity of Vermont Medical Center, Burlington

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.