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Completed

NCT Number: NCT04298853

Optimal Morphine Dosing Schedule for Neonatal Abstinence Syndrome

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.

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Key information

Conditions

Neonatal Abstinence Syndrome Chemically-Induced Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant, Newborn, Diseases Mental Disorders Neonatal Opioid Withdrawal Neonatal Opioid Withdrawal Syndrome Substance-Related Disorders

Age range

Up to 28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Indiana University Health Methodist Hospital

Indianapolis, Indiana, 46202, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Morphine PRN

Drug

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

Other names: morphine, morphine sulfate

Morphine scheduled

Drug

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

Other names: morphine, morphine sulfate

Primary outcomes

  1. 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

  2. Drop Out Rate

    Time frame: Through final follow-up call at 6 weeks of age

    Percentage of enrolled subjects who do not complete participation

  3. 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 outcomes

  1. Length of Hospital Stay From Birth to Discharge

    Time frame: Until discharge, up to 6 weeks

    Duration of hospitalization in days

  2. Total Cumulative Morphine Exposure

    Time frame: Until discharge, up to 6 weeks

    Per kilogram based on birth weight

  3. Peak Morphine Dose

    Time frame: Until discharge, up to 6 weeks

    Per kilogram based on birth weight

  4. Length of Morphine Treatment

    Time frame: Until discharge, up to 6 weeks

    Duration of morphine treatment in days

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 6, 2020
Registry last updated
Oct 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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