RECRUITING

Improving Neurodevelopmental ouTcomes After Prenatal Cannabinoid in uTero Exposure

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Conditions

Developmental DelayBehavioral health interventionPrenatal substance exposureNeurodevelopmental outcomesPediatric interventionDevelopmental disordersPediatric health

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-02-06
Study Completion:2026-07-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06423664

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.

Ages Eligible for Study:Not specified to 7 Days
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Age of majority, as defined by the state of residency
  2. * Cannabinoid use during pregnancy confirmed with self-report
  3. * Have the ability to speak, read, and understand English
  4. * Birthing parent who delivered at one of the hospitals where study team members have clinical privileges to access medical records
  5. * Has parental custody of the infant
  6. * Singleton pregnancy with live birth
  7. * Has an electronic device capable of watching videos and able to stream/download videos for viewing and permitting video conferencing
  8. * Has study access to the internet
  9. * Term infants at birth (\>37 weeks' gestation)
  10. * Biological child of the birthing parent
  1. * Other illicit drug use, excluding cannabinoids, during pregnancy (such as heroin or cocaine) per self-reported or toxicology results
  2. * Opiate use (prescribed or unprescribed) per self-report or toxicology results during this pregnancy
  3. * Prolonged hospitalization following delivery longer than 7 days
  4. * Has major birth defect(s) including physical anomalies including limb malformations/absence of limbs or chromosomal abnormalities
  5. * Diagnosed with neonatal encephalopathy, metabolic disorder, stroke, intracranial hemorrhage, or meningitis during birth hospitalization
  6. * Received any major surgical intervention during the birth hospitalization or required a prolonged birth hospitalization (prolonged hospitalization being any hospitalization longer than 7 days)

Contacts and Locations

Study Contact

Song Ounpraseuth, PhD
CONTACT
(501) 686-5647
STOunpraseuth@uams.edu
Matthew Henry, MSc
CONTACT
(501) 686-5647
mhenry3@uams.edu

Principal Investigator

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 Locations (Sites)

University of New Mexico Health Sciences Center
Albuquerque, New Mexico, 87131
United States
Avera Research Institute
Sioux Falls, South Dakota, 57108
United States
University of Vermont Medical Center
Burlington, Vermont, 05401
United States

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-06
Study Completion Date2026-07-15

Study Record Updates

Study Start Date2025-02-06
Study Completion Date2026-07-15

Terms related to this study

Keywords Provided by Researchers

  • Behavioral health intervention
  • Prenatal substance exposure
  • Neurodevelopmental outcomes
  • Pediatric intervention
  • Developmental disorders
  • Pediatric health

Additional Relevant MeSH Terms

  • Developmental Delay