NCT06423664 Improving Neurodevelopmental ouTcomes After Prenatal Cannabinoid in uTero Exposure
| NCT ID | NCT06423664 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IDeA States Pediatric Clinical Trials Network |
| Condition | Developmental Delay |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-02-06 |
| Primary Completion | 2026-06-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2025-02-06 with a primary completion date of 2026-06-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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)
Contact & Investigator
Jessie Maxwell, MD
PRINCIPAL INVESTIGATOR
University of New Mexico
Frequently Asked Questions
Who can join the NCT06423664 clinical trial?
This trial is open to participants of all sexes, up to 7 Days, studying Developmental Delay. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06423664 currently recruiting?
Yes, NCT06423664 is actively recruiting participants. Contact the research team at STOunpraseuth@uams.edu for enrollment information.
Where is the NCT06423664 trial being conducted?
This trial is being conducted at Albuquerque, United States, Sioux Falls, United States, Burlington, United States.
Who is sponsoring the NCT06423664 clinical trial?
NCT06423664 is sponsored by IDeA States Pediatric Clinical Trials Network. The principal investigator is Jessie Maxwell, MD at University of New Mexico. The trial plans to enroll 20 participants.