Optimal Morphine Dosing Schedule for Neonatal Abstinence Syndrome

Neonatal Abstinence Syndrome Clinical Trial

Official title:

Optimal Morphine Dosing Schedule for Neonatal Abstinence Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04298853
• Other study ID #: 1910620136
• Status: Completed
• Phase: Phase 4
• Start date: June 30, 2020
• Est. completion date: October 1, 2021

Study information

• Verified date: September 2022
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: October 1, 2021
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 28 Days

Eligibility

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

Related Conditions & MeSH terms

• Neonatal Abstinence Syndrome
• Neonatal Opioid Withdrawal
• Neonatal Opioid Withdrawal Syndrome
• Substance Withdrawal Syndrome
• Syndrome

Intervention

Drug:
• Morphine PRN
Dose given every 3 hours as-needed for severe NAS, defined by a threshold Finnegan score.
• Morphine scheduled
Dose given every 3 hours on a scheduled basis and slowly weaned once stabilized.

Locations

Country	Name	City	State
United States	Indiana University Health Methodist Hospital	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Enrollment Rate	Percentage of eligible subjects who were enrolled and randomized in the study	Prior to second dose of morphine, within 4 hours
Primary	Drop Out Rate	Percentage of enrolled subjects who do not complete participation	Through final follow-up call at 6 weeks of age
Primary	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	Length of Hospital Stay From Birth to Discharge	Duration of hospitalization in days	Until discharge, up to 6 weeks
Secondary	Total Cumulative Morphine Exposure	Per kilogram based on birth weight	Until discharge, up to 6 weeks
Secondary	Peak Morphine Dose	Per kilogram based on birth weight	Until discharge, up to 6 weeks
Secondary	Length of Morphine Treatment	Duration of morphine treatment in days	Until discharge, up to 6 weeks