Opioid Exposure for Neonatal Abstinence Syndrome
(OBOE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to understand how prenatal opioid exposure affects a baby's brain development and behavior during the first two years of life. Researchers seek to determine how factors such as maternal stress or depression might alter these effects. Babies exposed to opioids in the last few months of pregnancy and born full-term (at least 37 weeks) are suitable candidates. The study will compare their development to that of babies not exposed to drugs before birth. As an unphased trial, it offers a unique opportunity to contribute to understanding early childhood development and potentially improve future care for affected infants.
Why are researchers excited about this trial?
Researchers are excited about this trial because it aims to uncover the long-term outcomes of babies exposed to opioids in the womb. Unlike current approaches that primarily focus on immediate treatment of withdrawal symptoms using medications like methadone or buprenorphine, this study looks at the broader picture of childhood development and health over time. Understanding these long-term effects could lead to better care strategies and support systems, ultimately improving the quality of life for these children.
Who Is on the Research Team?
Carla Bann, PhD
Principal Investigator
RTI International
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Initial assessments including MRI and developmental evaluations are conducted
Longitudinal Monitoring
Ongoing monitoring of brain development and behavioral outcomes through MRI and developmental assessments
Follow-up
Participants are monitored for safety and effectiveness after the main study period
What Are the Treatments Tested in This Trial?
Find a Clinic Near You
Who Is Running the Clinical Trial?
Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program
Lead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
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