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Optimal Morphine Dosing Schedule for Neonatal Abstinence Syndrome

Sponsor
Indiana University (Other)
Overall Status
Completed
CT.gov ID
NCT04298853
Collaborator
(none)
17
Enrollment
1
Location
2
Arms
15
Actual Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Morphine PRN
  • Drug: Morphine scheduled
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
17 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Optimal Morphine Dosing Schedule for Neonatal Abstinence Syndrome
Actual Study Start Date :
Jun 30, 2020
Actual Primary Completion Date :
Oct 1, 2021
Actual Study Completion Date :
Oct 1, 2021

Arms and Interventions

Arm Intervention/Treatment
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.

Drug: Morphine scheduled
Dose given every 3 hours on a scheduled basis and slowly weaned once stabilized.
Other Names:
  • morphine
  • morphine sulfate

    		•
    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.

    Drug: Morphine PRN
    Dose given every 3 hours as-needed for severe NAS, defined by a threshold Finnegan score.
    Other Names:
  • morphine
  • morphine sulfate

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Enrollment Rate [Prior to second dose of morphine, within 4 hours]

      Percentage of eligible subjects who were enrolled and randomized in the study

    2. Drop Out Rate [Through final follow-up call at 6 weeks of age]

      Percentage of enrolled subjects who do not complete participation

    3. Number of Subjects Switched to Standard Arm [24 hours]

      Number of study group infants removed from study protocol and treated under standard care

    Secondary Outcome Measures

    1. Length of Hospital Stay from birth to discharge [Until discharge, up to 6 weeks]

      Duration of hospitalization in days

    2. Total Cumulative Morphine Exposure [Until discharge, up to 6 weeks]

      Per kilogram of body weight

    3. Peak Morphine Dose [Until discharge, up to 6 weeks]

      Per kilogram of body weight

    4. Length of Morphine Treatment [Until discharge, up to 6 weeks]

      Duration of morphine treatment in days

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 28 Days
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Indiana University Health Methodist Hospital Indianapolis Indiana United States 46202

    Sponsors and Collaborators

    • Indiana University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Anna Thomas, Assistant Professor of Clinical Pediatrics, Indiana University
    ClinicalTrials.gov Identifier:
    NCT04298853
    Other Study ID Numbers:
    • 1910620136
    First Posted:
    Mar 6, 2020
    Last Update Posted:
    Feb 18, 2022
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Anna Thomas, Assistant Professor of Clinical Pediatrics, Indiana University
    morphine
    Finnegan
    Additional relevant MeSH terms:
    Neonatal Abstinence Syndrome
    Syndrome
    Substance Withdrawal Syndrome
    Morphine

    Study Results

    No Results Posted as of Feb 18, 2022