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 a research study that aims to explore how a special program can help improve the development of infants who were exposed to cannabinoids (like marijuana) before birth. Researchers want to see if this program can positively affect the growth and development of babies who might face challenges because of that exposure. The study will include 20 parent-infant pairs and will take place at three different locations over about 22 months.

To participate, parents must be adults who used cannabinoids during their pregnancy and have custody of their baby. The baby must have been born healthy at term (after 37 weeks). Participants will need to have access to the internet and an electronic device to watch videos and communicate with the study team. While the study focuses on gathering information rather than testing a treatment, it’s an important step in understanding how to support these infants and their families better. If you think you might be eligible or are interested in learning more, the research team would be happy to provide additional details.

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