Trials
Search / Trial NCT06423664

Improving Neurodevelopmental ouTcomes After Prenatal Cannabinoid in uTero Exposure

Launched by IDEA STATES PEDIATRIC CLINICAL TRIALS NETWORK · May 16, 2024

Trial Information

Current as of February 19, 2025

Not yet recruiting

Keywords

Behavioral Health Intervention Prenatal Substance Exposure Neurodevelopmental Outcomes Pediatric Intervention Developmental Disorders Pediatric Health

ClinConnect Summary

The INTACT trial is designed to address the need for interventions to improve neurodevelopmental outcomes in infants exposed to cannabinoids in utero. It is a multi-site pilot study conducted across three Institutional Development Award (IDeA) States Pediatric Clinical Trials Network (ISPCTN) sites. The trial aims to evaluate the feasibility of the INTACT Intervention program, which focuses on training birthing parents in contingent responding to promote early language, cognitive, and social development in their infants.

The study intervention consists of 12 monthly INTACT intervention coa...

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

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

About Idea States Pediatric Clinical Trials Network

The IDEA States Pediatric Clinical Trials Network is a collaborative initiative focused on advancing pediatric healthcare through innovative clinical research. By bringing together leading institutions, researchers, and healthcare professionals, the network aims to facilitate the development and evaluation of new treatments and therapies tailored specifically for children. Committed to enhancing the safety and efficacy of pediatric care, IDEA States prioritizes rigorous scientific standards and ethical considerations in its trials, ultimately striving to improve health outcomes for young patients across diverse populations.

Locations

Burlington, Vermont, United States

Albuquerque, New Mexico, United States

Sioux Falls, South Dakota, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0