Optimal Morphine Dosing Schedule for Neonatal Abstinence Syndrome

Overview

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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 1, 2021

Interventions

  • Drug: Morphine PRN
    • Dose given every 3 hours as-needed for severe NAS, defined by a threshold Finnegan score.
  • Drug: Morphine scheduled
    • Dose given every 3 hours on a scheduled basis and slowly weaned once stabilized.

Arms, Groups and Cohorts

  • Active Comparator: Standard
    • 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.
  • Experimental: Study
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Enrollment Rate
    • Time Frame: Prior to second dose of morphine, within 4 hours
    • Percentage of eligible subjects who were enrolled and randomized in the study
  • Drop Out Rate
    • Time Frame: 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
    • Time Frame: 24 hours
    • Number of study group infants removed from study protocol and treated under standard care.

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 28 Days

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Indiana University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Anna Thomas, Assistant Professor of Clinical Pediatrics – Indiana University

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