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Improving Neurodevelopmental ouTcomes After Prenatal Cannabinoid in uTero Exposure

IDeA States Pediatric Clinical Trials Network · with University of New Mexico, University of Vermont · NCT06423664

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Up to age 0 mo · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
20
US sites recruiting
3
Study start
February 6, 2025
Record last updated
June 24, 2025

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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.

Being studied: Play and Learn Strategies (PALS) Program

Conditions: Developmental Delay

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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)

Recruiting US locations

  • University of New Mexico Health Sciences Center

    Albuquerque, NM 87131

    Site contact: Jessie Maxwell, MD · JRMaxwell@salud.unm.edu

  • Avera Research Institute

    Sioux Falls, SD 57108

    Site contact: Maria Barber, DO · Maria.Barber@avera.org

  • University of Vermont Medical Center

    Burlington, VT 05401

    Site contact: Leigh-Anne Cioffredi, MD · Leigh-Anne.Cioffredi@uvmhealth.org

Study contacts (from the official record)

  • Song Ounpraseuth, PhD · (501) 686-5647 · STOunpraseuth@uams.edu
  • Matthew Henry, MSc · (501) 686-5647 · mhenry3@uams.edu
All pregnancy studies in New Mexico →
Improving Neurodevelopmental ouTcomes After Prenatal Cannabinoid… (NCT06423664) | Bored Studies