Status:
COMPLETED
Non-Opiate Treatment After Prenatal Opiate Exposure to Prevent Postnatal Injury to the Young Brain
Lead Sponsor:
Henrietta Bada
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Neonatal Abstinence Syndrome
Eligibility:
All Genders
12-7 years
Phase:
PHASE3
Brief Summary
The long term goals of our research are to establish the best pharmacological treatment for NAS and determine how pharmacologic treatment of NAS affects long-term developmental outcomes. The objective...
Detailed Description
In this current proposal, the research plan is based on our pilot study, which randomized infants with NAS to receive morphine or clonidine. The treatment groups were similar as to mean birth weight, ...
Eligibility Criteria
Inclusion
- Gestational age (GA) \> or equal to 35 weeks
- Known prenatal opiate exposure (by mother admitting use, mom with positive opiate screen during pregnancy, or positive neonatal urine and meconium screening)
- No known prenatal cocaine exposure
- No morphine or clonidine dose before enrollment
- Symptomatic with Finnegan scores (FS): 3 consecutive scores greater than or equal to 8, OR 2 consecutive scores greater than or equal to 12, and/or with attending decision to treat for NAS
- Less than or equal to 7 days of age
- Attending physician decides to start pharmacologic treatment and agrees to infant's study participation
Exclusion
- Seizures
- Major congenital malformations
- Blood pressure instability
- Major medical condition in addition to NAS
- Parents unable to understand English
Key Trial Info
Start Date :
December 7 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 10 2024
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT03396588
Start Date
December 7 2017
End Date
April 10 2024
Last Update
May 23 2025
Active Locations (1)
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1
Kentucky Children's Hospital
Lexington, Kentucky, United States, 40536