Optimal Morphine Dosing Schedule for Neonatal Abstinence Syndrome

NCT04298853 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 1910620136
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Neonatal Abstinence Syndrome; Neonatal Opioid Withdrawal; Neonatal Opioid Withdrawal Syndrome

Keywords

morphine; Finnegan

Outcome Measures

Primary Outcomes (3)

• Enrollment Rate

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

  Prior to second dose of morphine, within 4 hours

• Drop Out Rate

  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

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

  24 hours

Secondary Outcomes (4)

• Length of Hospital Stay From Birth to Discharge

  Until discharge, up to 6 weeks

• Total Cumulative Morphine Exposure

  Until discharge, up to 6 weeks

• Peak Morphine Dose

  Until discharge, up to 6 weeks

• Length of Morphine Treatment

  Until discharge, up to 6 weeks

Study Arms (2)

Standard

ACTIVE COMPARATOR

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

Study

EXPERIMENTAL

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

Interventions

Morphine PRN DRUG

Dose given every 3 hours as-needed for severe NAS, defined by a threshold Finnegan score.

Also known as: morphine, morphine sulfate

Study

Morphine scheduled DRUG

Dose given every 3 hours on a scheduled basis and slowly weaned once stabilized.

Also known as: morphine, morphine sulfate

Standard

Eligibility Criteria

• Age: Up to 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• congenital anomalies or suspected genetic condition
• co-morbid conditions that require sedation or analgesia due to clinical condition
• ongoing need for respiratory support

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University Health Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Neonatal Abstinence Syndrome

Interventions

Morphine

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Limitations and Caveats

The goal number of subjects was 24 and this was not achieved, which is a limitation. We found that social factors, such as adoption plans and foster placement, limited enrollment of otherwise eligible subjects and resulted in difficulty with follow-up.

Results Point of Contact

• Title: Anna Thomas, MD
• Organization: Indiana University School of Medicine

aeschwar@iu.edu

317-944-9392

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Pediatrics

Study Record Dates

• First Submitted: March 4, 2020
• First Posted: March 6, 2020
• Study Start: June 30, 2020
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: October 6, 2022
• Results First Posted: September 8, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)