Actively Recruiting
Improving Neurodevelopmental ouTcomes After Prenatal Cannabinoid in uTero Exposure
Led by IDeA States Pediatric Clinical Trials Network · Updated on 2025-06-24
20
Participants Needed
3
Research Sites
81 weeks
Total Duration
On this page
Sponsors
I
IDeA States Pediatric Clinical Trials Network
Lead Sponsor
U
University of New Mexico
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Improving Neurodevelopmental ouTcomes After Prenatal Cannabinoid in uTero Exposure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Birthing parent is at least the age of majority as defined by their state of residency
- Birthing parent used cannabinoids during pregnancy confirmed by self-report
- Birthing parent can speak, read, and understand English
- Birthing parent delivered at one of the hospitals where study team members have clinical access to medical records
- Birthing parent has custody of the infant
- Birthing parent has an electronic device capable of streaming or downloading videos and permitting video conferencing
- Birthing parent has access to the internet
- Infant is a term baby born after more than 37 weeks gestation
- Infant is the biological child of the birthing parent
You will not qualify if you...
- Birthing parent used illicit drugs other than cannabinoids (e.g., heroin or cocaine) during pregnancy by self-report or toxicology
- Birthing parent used opiates (prescribed or unprescribed) during pregnancy by self-report or toxicology
- Birthing parent had a prolonged hospital stay longer than 7 days after delivery
- Infant has major birth defects including limb malformations or chromosomal abnormalities
- Infant diagnosed with neonatal encephalopathy, metabolic disorders, stroke, intracranial hemorrhage, or meningitis during birth hospitalization
- Infant had major surgery or prolonged birth hospitalization longer than 7 days
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, United States, 87131
Actively Recruiting
2
Avera Research Institute
Sioux Falls, South Dakota, United States, 57108
Actively Recruiting
3
University of Vermont Medical Center
Burlington, Vermont, United States, 05401
Actively Recruiting
Research Team
S
Song Ounpraseuth, PhD
CONTACT
M
Matthew Henry, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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