At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 17 enrolled
Drug / intervention
Morphine PRN +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Optimal Morphine Dosing Schedule for Neonatal Abstinence Syndrome
In Brief
A Phase 4 clinical trial evaluating Morphine PRN and Morphine scheduled for Neonatal Abstinence Syndrome and 2 related conditions. Completed, enrolled 17 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeonatal Abstinence Syndrome, Neonatal Opioid Withdrawal, Neonatal Opioid Withdrawal Syndrome
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
202120222023202420252026
First PostedMar 2020
Enrollment StartJun 2020
Primary CompletionOct 2021
TodayJul 2026
First PostedMar 6, 2020
Enrollment StartJun 30, 2020
Primary CompletionOct 1, 2021
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 6.3 years ago
Interventions
Morphine PRNdrug
Dose given every 3 hours as-needed for severe NAS, defined by a threshold Finnegan score.
Morphine scheduleddrug
Dose given every 3 hours on a scheduled basis and slowly weaned once stabilized.