Neonatal Opioid Withdrawal Syndrome Clinical Trial
Official title:
ACT NOW Longitudinal Study: Outcomes of Babies With Opioid Exposure Study
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
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. ;
| 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| Withdrawn |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 |
NCT03911466 -
Medication Treatment for Opioid Use Disorder in Expectant Mothers: Conceptual Model Assessments Sub-study
|
Phase 3 | |
| Active, not recruiting |
NCT03918850 -
Medication Treatment for Opioid Use Disorder in Expectant Mothers
|
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
|