Optimal Morphine Dosing Schedule for Neonatal Abstinence Syndrome

September 9, 2022 updated by: Anna Thomas, Indiana University
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Health Methodist Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 4 weeks (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Prior to second dose of morphine, within 4 hours
Drop Out Rate
Time Frame: Through final follow-up call at 6 weeks of age
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
Time Frame: 24 hours
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
Time Frame: Until discharge, up to 6 weeks
Duration of hospitalization in days
Until discharge, up to 6 weeks
Total Cumulative Morphine Exposure
Time Frame: Until discharge, up to 6 weeks
Per kilogram based on birth weight
Until discharge, up to 6 weeks
Peak Morphine Dose
Time Frame: Until discharge, up to 6 weeks
Per kilogram based on birth weight
Until discharge, up to 6 weeks
Length of Morphine Treatment
Time Frame: Until discharge, up to 6 weeks
Duration of morphine treatment in days
Until discharge, up to 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2020

Primary Completion (Actual)

October 1, 2021

Study Completion (Actual)

October 1, 2021

Study Registration Dates

First Submitted

March 4, 2020

First Submitted That Met QC Criteria

March 4, 2020

First Posted (Actual)

March 6, 2020

Study Record Updates

Last Update Posted (Actual)

October 6, 2022

Last Update Submitted That Met QC Criteria

September 9, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1910620136

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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