Optimal Morphine Dosing Schedule for Neonatal Abstinence Syndrome

Study Overview
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Brief Summary
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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.

Official Title
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Optimal Morphine Dosing Schedule for Neonatal Abstinence Syndrome

Conditions
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Neonatal Abstinence Syndrome, Neonatal Opioid Withdrawal, Neonatal Opioid Withdrawal Syndrome

Intervention / Treatment
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* Drug: Morphine PRN
* Drug: Morphine scheduled


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: newborn greater than or equal to 35 weeks gestation intrauterine opioid exposure signs and symptoms of opioid withdrawal Exclusion Criteria: congenital anomalies or suspected genetic condition co-morbid conditions that require sedation or analgesia due to clinical condition ongoing need for respiratory support

Ages Eligible for Study
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Maximum Age: 28 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard<br>Infants randomized to the standard arm will receive morphine based on the current institutional treatment protocol: oral morphine 0.05 mg/kg/dose given every 3 hours, initiated if threshold Finnegan score is met. Once stabilized, dose will be weaned by 10% of peak dose per day until discontinuation. | Drug: Morphine scheduled<br>* Dose given every 3 hours on a scheduled basis and slowly weaned once stabilized.<br>* Other names: morphine sulfate;|
| Experimental: Study<br>Infants randomized to the study arm will receive oral morphine 0.05 mg/kg/dose as needed for an elevated Finnegan score. May receive morphine as frequently as every 3 hours if needed. | Drug: Morphine PRN<br>* Dose given every 3 hours as-needed for severe NAS, defined by a threshold Finnegan score.<br>* Other names: morphine sulfate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Enrollment Rate | Percentage of eligible subjects who were enrolled and randomized in the study | Prior to second dose of morphine, within 4 hours | 
| Drop Out Rate | Percentage of enrolled subjects who do not complete participation | 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. | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of Hospital Stay From Birth to Discharge | Duration of hospitalization in days | Until discharge, up to 6 weeks | 
| Total Cumulative Morphine Exposure | Per kilogram based on birth weight | Until discharge, up to 6 weeks | 
| Peak Morphine Dose | Per kilogram based on birth weight | Until discharge, up to 6 weeks | 
| Length of Morphine Treatment | Duration of morphine treatment in days | Until discharge, up to 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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morphine, Finnegan