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New treatment option for Developmental Delay
Official title Improving Neurodevelopmental ouTcomes After Prenatal Cannabinoid in uTero Exposure
ClinicalTrials.gov ID: NCT06423664
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 7. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Albuquerque, New Mexico, United States
- Sioux Falls, South Dakota, United States
- Burlington, Vermont, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, up to 7 days. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Albuquerque, New Mexico, United States; Sioux Falls, South Dakota, United States; Burlington, Vermont, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.