Improving Neurodevelopmental ouTcomes After Prenatal Cannabinoid in uTero Exposure
Recruiting now · Not applicable
Conditions studied: Developmental Delay
In brief
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.
Key facts
- Study ID
- NCT06423664
- Run by
- IDeA States Pediatric Clinical Trials Network
- People needed
- 20
- Starts
- 2025-02-06
- Expected to finish
- 2026-08-31
- Last updated by the study team
- 2025-06-24
Who can join
Age: any, up to 0. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- University of New Mexico Health Sciences Center — Albuquerque, New Mexico, United States (enrolling)
- Avera Research Institute — Sioux Falls, South Dakota, United States (enrolling)
- University of Vermont Medical Center — Burlington, Vermont, United States (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.