Improving Neurodevelopmental ouTcomes After Prenatal Cannabinoid in uTero Exposure

Launched by IDEA STATES PEDIATRIC CLINICAL TRIALS NETWORK · May 16, 2024

Keywords

ClinConnect Summary

The INTACT trial is designed to address the need for interventions to improve neurodevelopmental outcomes in infants exposed to cannabinoids in utero. It is a multi-site pilot study conducted across three Institutional Development Award (IDeA) States Pediatric Clinical Trials Network (ISPCTN) sites. The trial aims to evaluate the feasibility of the INTACT Intervention program, which focuses on training birthing parents in contingent responding to promote early language, cognitive, and social development in their infants.

The study intervention consists of 12 monthly INTACT intervention coa...

Gender

ALL

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)

Trial Officials