Status:
COMPLETED
Optimal Morphine Dosing Schedule for Neonatal Abstinence Syndrome
Lead Sponsor:
Indiana University
Conditions:
Neonatal Abstinence Syndrome
Neonatal Opioid Withdrawal
Eligibility:
All Genders
Up to 28 years
Phase:
PHASE4
Brief Summary
Randomized pilot trial comparing scheduled morphine dosing with a weaning protocol to intermittent morphine dosing on an as-needed basis for newborns with neonatal abstinence syndrome.
Eligibility Criteria
Inclusion
- newborn greater than or equal to 35 weeks gestation
- intrauterine opioid exposure
- signs and symptoms of opioid withdrawal
Exclusion
- congenital anomalies or suspected genetic condition
- co-morbid conditions that require sedation or analgesia due to clinical condition
- ongoing need for respiratory support
Key Trial Info
Start Date :
June 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2021
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT04298853
Start Date
June 30 2020
End Date
October 1 2021
Last Update
October 6 2022
Active Locations (1)
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1
Indiana University Health Methodist Hospital
Indianapolis, Indiana, United States, 46202