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โ† Trials
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Improving Neurodevelopmental ouTcomes After Prenatal Cannabinoid in uTero Exposure

RecruitingNAAges any - 7 DaysAllIDeA States Pediatric Clinical Trials Network
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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)
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What it tests

  • Play and Learn Strategies (PALS) Program
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Where

3 sites
University of New Mexico Health Sciences Center
Albuquerque, United States
Avera Research Institute
Sioux Falls, United States
University of Vermont Medical Center
Burlington, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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