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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
17
Dose given every 3 hours as-needed for severe NAS, defined by a threshold Finnegan score.
Dose given every 3 hours on a scheduled basis and slowly weaned once stabilized.
Indiana University Health Methodist Hospital
Indianapolis, Indiana, United States
Enrollment Rate
Percentage of eligible subjects who were enrolled and randomized in the study
Time frame: Prior to second dose of morphine, within 4 hours
Drop Out Rate
Percentage of enrolled subjects who do not complete participation
Time frame: Through final follow-up call at 6 weeks of age
Number of Study Group Subjects Switched to Standard Arm
Number of study group infants removed from study protocol and treated under standard care.
Time frame: 24 hours
Length of Hospital Stay From Birth to Discharge
Duration of hospitalization in days
Time frame: Until discharge, up to 6 weeks
Total Cumulative Morphine Exposure
Per kilogram based on birth weight
Time frame: Until discharge, up to 6 weeks
Peak Morphine Dose
Per kilogram based on birth weight
Time frame: Until discharge, up to 6 weeks
Length of Morphine Treatment
Duration of morphine treatment in days
Time frame: Until discharge, up to 6 weeks
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