Back to resultsOptimal Morphine Dosing Schedule for Neonatal Abstinence Syndrome
Primary Purpose
Neonatal Abstinence Syndrome, Neonatal Opioid Withdrawal, Neonatal Opioid Withdrawal Syndrome
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Morphine PRN
Morphine scheduled
Sponsored by
About this trial
This is an interventional other trial for Neonatal Abstinence Syndrome focused on measuring morphine, Finnegan
Eligibility Criteria
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
Sites / Locations
- Indiana University Health Methodist Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard
Study
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Enrollment Rate
Percentage of eligible subjects who were enrolled and randomized in the study
Drop Out Rate
Percentage of enrolled subjects who do not complete participation
Number of Study Group Subjects Switched to Standard Arm
Number of study group infants removed from study protocol and treated under standard care.
Secondary Outcome Measures
Length of Hospital Stay From Birth to Discharge
Duration of hospitalization in days
Total Cumulative Morphine Exposure
Per kilogram based on birth weight
Peak Morphine Dose
Per kilogram based on birth weight
Length of Morphine Treatment
Duration of morphine treatment in days
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04298853
Brief Title
Optimal Morphine Dosing Schedule for Neonatal Abstinence Syndrome
Official Title
Optimal Morphine Dosing Schedule for Neonatal Abstinence Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
June 30, 2020 (Actual)
Primary Completion Date
October 1, 2021 (Actual)
Study Completion Date
October 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
4. Oversight
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
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Abstinence Syndrome, Neonatal Opioid Withdrawal, Neonatal Opioid Withdrawal Syndrome
Keywords
morphine, Finnegan
7. Study Design
Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Study
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Morphine PRN
Other Intervention Name(s)
morphine, morphine sulfate
Intervention Description
Dose given every 3 hours as-needed for severe NAS, defined by a threshold Finnegan score.
Intervention Type
Drug
Intervention Name(s)
Morphine scheduled
Other Intervention Name(s)
morphine, morphine sulfate
Intervention Description
Dose given every 3 hours on a scheduled basis and slowly weaned once stabilized.
Primary Outcome Measure Information:
Title
Enrollment Rate
Description
Percentage of eligible subjects who were enrolled and randomized in the study
Time Frame
Prior to second dose of morphine, within 4 hours
Title
Drop Out Rate
Description
Percentage of enrolled subjects who do not complete participation
Time Frame
Through final follow-up call at 6 weeks of age
Title
Number of Study Group Subjects Switched to Standard Arm
Description
Number of study group infants removed from study protocol and treated under standard care.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Length of Hospital Stay From Birth to Discharge
Description
Duration of hospitalization in days
Time Frame
Until discharge, up to 6 weeks
Title
Total Cumulative Morphine Exposure
Description
Per kilogram based on birth weight
Time Frame
Until discharge, up to 6 weeks
Title
Peak Morphine Dose
Description
Per kilogram based on birth weight
Time Frame
Until discharge, up to 6 weeks
Title
Length of Morphine Treatment
Description
Duration of morphine treatment in days
Time Frame
Until discharge, up to 6 weeks
10. Eligibility
Sex
All
Maximum Age & Unit of Time
28 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Indiana University Health Methodist Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Optimal Morphine Dosing Schedule for Neonatal Abstinence Syndrome
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