Optimal Morphine Dosing Schedule for Neonatal Abstinence Syndrome

Phase 4

Completed

• Conditions: Neonatal Abstinence Syndrome; Neonatal Opioid Withdrawal; Neonatal Opioid Withdrawal Syndrome
• Interventions: Drug: Morphine PRN; Drug: Morphine scheduled

• Registration Number: NCT04298853
• Lead Sponsor: Indiana University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-03-04
• Study First Submitted QC: 2020-03-04
• Study First Posted: 2020-03-06
• Study Start: 2020-06-30
• Primary Completion: 2021-10-01
• Study Completion: 2021-10-01
• Results First Submitted: 2022-08-16
• Results First Submitted QC: 2022-08-16
• Status Verified: 2022-09
• Results First Posted: 2022-09-08
• Last Update Submitted: 2022-09-09
• Last Update Posted: 2022-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

• newborn greater than or equal to 35 weeks gestation
• intrauterine opioid exposure
• signs and symptoms of opioid withdrawal

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study	Morphine PRN	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.
Standard	Morphine scheduled	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.

Primary Outcome Measures

Name	Time	Method
Enrollment Rate	Prior to second dose of morphine, within 4 hours	Percentage of eligible subjects who were enrolled and randomized in the study
Drop Out Rate	Through final follow-up call at 6 weeks of age	Percentage of enrolled subjects who do not complete participation
Number of Study Group Subjects Switched to Standard Arm	24 hours	Number of study group infants removed from study protocol and treated under standard care.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Indiana University Health Methodist Hospital; 🇺🇸 Indianapolis, Indiana, United States