Improving Neurodevelopmental ouTcomes After Prenatal Cannabinoid in uTero Exposure

Description

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.

Conditions

Developmental Delay

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Study Overview

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Study Details

Study overview

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.

Pilot Feasibility Trial of Improving Neurodevelopmental ouTcomes After Prenatal Cannabinoid in uTero Exposure (INTACT)

Improving Neurodevelopmental ouTcomes After Prenatal Cannabinoid in uTero Exposure

Condition
Developmental Delay
Intervention / Treatment

-

Contacts and Locations

Albuquerque

University of New Mexico Health Sciences Center, Albuquerque, New Mexico, United States, 87131

Sioux Falls

Avera Research Institute, Sioux Falls, South Dakota, United States, 57108

Burlington

University of Vermont Medical Center, Burlington, Vermont, United States, 05401

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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
  • * Term infants at birth (\>37 weeks' gestation)
  • * Biological child of the 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
  • * 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)

Ages Eligible for Study

to 7 Days

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

IDeA States Pediatric Clinical Trials Network,

Jessie Maxwell, MD, PRINCIPAL_INVESTIGATOR, University of New Mexico

Leigh-Anne Cioffredi, MD, PRINCIPAL_INVESTIGATOR, University of Vermont

Maria Barber, DO, PRINCIPAL_INVESTIGATOR, Avera Research Institute

Study Record Dates

2026-07-15