Improving Neurodevelopmental ouTcomes After Prenatal Cannabinoid in uTero Exposure
- Conditions
- Developmental Delay
- Registration Number
- NCT06423664
- Lead Sponsor
- IDeA States Pediatric Clinical Trials Network
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br>Birthing Parent<br><br> - Age of majority, as defined by the state of residency<br><br> - Cannabinoid use during pregnancy confirmed with self-report<br><br> - Have the ability to speak, read, and understand English<br><br> - Birthing parent who delivered at one of the hospitals where study team members have<br> clinical privileges to access medical records<br><br> - Has parental custody of the infant<br><br> - Singleton pregnancy with live birth<br><br> - Has an electronic device capable of watching videos and able to stream/download<br> videos for viewing and permitting video conferencing<br><br> - Has study access to the internet<br><br>Infant<br><br> - Term infants at birth (>37 weeks' gestation)<br><br> - Biological child of the birthing parent<br><br>Exclusion Criteria:<br><br>Birthing Parent<br><br> - Other illicit drug use, excluding cannabinoids, during pregnancy (such as heroin or<br> cocaine) per self-reported or toxicology results<br><br> - Opiate use (prescribed or unprescribed) per self-report or toxicology results during<br> this pregnancy<br><br> - Prolonged hospitalization following delivery longer than 7 days<br><br>Infant<br><br> - Has major birth defect(s) including physical anomalies including limb<br> malformations/absence of limbs or chromosomal abnormalities<br><br> - Diagnosed with neonatal encephalopathy, metabolic disorder, stroke, intracranial<br> hemorrhage, or meningitis during birth hospitalization<br><br> - Received any major surgical intervention during the birth hospitalization or<br> required a prolonged birth hospitalization (prolonged hospitalization being any<br> hospitalization longer than 7 days)
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of approached participants that are eligible for study participation;Percentage of participants that complete their final visit;Percentage of participants that receive a sufficient number of coaching sessions
- Secondary Outcome Measures
Name Time Method