Clinical Trials Logo

Clinical Trial Summary

The objective of this longitudinal cohort study is to quantify the effects of antenatal opioid exposure on the trajectory of brain development over the first 2 years of life, examine associations with developmental and neurobehavioral outcomes, and explore how specific factors (differing antenatal and postnatal exposures, severity of neonatal opioid withdrawal, maternal stress/depression/parenting) modify these effects


Clinical Trial Description

This objective of this longitudinal cohort study is to prospectively examine the medical, neuroanatomical, neurodevelopmental, behavioral, and social/family/home outcomes of infants who were exposed to opioids in utero. Match control infants will be recruited into the study and based on birth hospital and birth month of the exposed infants. The study will quantify the effects of antenatal opioid exposure on the trajectory of brain development over the first 2 years of life, examine associations with developmental and neurobehavioral outcomes, and explore how specific factors (differing antenatal and postnatal exposures, severity of neonatal opioid withdrawal, maternal stress/depression/parenting) modify these effects. The investigators hypothesize that neural connectivity and neuroanatomical volumes are altered by antenatal opioid exposure and that the magnitude of these alterations correlates with developmental and behavioral outcomes. Further, maternal and environmental factors interact with antenatal opioid exposure to influence the trajectories of connectivity, development, and behavior over the first 2 years of life. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04149509
Study type Observational
Source Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program
Contact Carla Bann, PhD
Phone 919-485-2773
Email cmb@rti.org
Status Recruiting
Phase
Start date August 19, 2020
Completion date July 2023

See also
  Status Clinical Trial Phase
Active, not recruiting NCT04214834 - Trial to Shorten Pharmacologic Treatment of Newborns With Neonatal Opioid Withdrawal Syndrome (NOWS) Phase 3
Withdrawn NCT04455802 - Randomized Control Trial of Buprenorphine vs. Morphine for the Treatment of Neonatal Opioid Withdrawal Syndrome (NOWS) Phase 3
Recruiting NCT04834297 - Use of SVS Device to Improve Outcomes for Neonatal Opioid Withdrawal Syndrome. N/A
Completed NCT04298853 - Optimal Morphine Dosing Schedule for Neonatal Abstinence Syndrome Phase 4
Recruiting NCT05129020 - Neurostimulation to Improve NOWS Outcomes N/A
Active, not recruiting NCT03918850 - Medication Treatment for Opioid Use Disorder in Expectant Mothers Phase 3
Active, not recruiting NCT03911466 - Medication Treatment for Opioid Use Disorder in Expectant Mothers: Conceptual Model Assessments Sub-study Phase 3
Recruiting NCT05937594 - MicroRNA Biomarkers for Neonatal Opioid Withdrawal Syndrome
Terminated NCT04104646 - CHF6563 in Babies With Neonatal Opioid Withdrawal Syndrome Phase 2
Completed NCT04049799 - Maternal Opioid Treatment: Human Experimental Research - Data Yield Appropriate Decisions