Status:

COMPLETED

Optimal Morphine Dosing Schedule for Neonatal Abstinence Syndrome

Lead Sponsor:

Indiana University

Conditions:

Neonatal Abstinence Syndrome

Neonatal Opioid Withdrawal

Eligibility:

All Genders

Up to 28 years

Phase:

PHASE4

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.

Eligibility Criteria

Inclusion

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

Exclusion

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

Key Trial Info

Start Date :

June 30 2020

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

October 1 2021

Estimated Enrollment :

17 Patients enrolled

Trial Details

Trial ID

NCT04298853

Start Date

June 30 2020

End Date

October 1 2021

Last Update

October 6 2022

Active Locations (1)

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1

Indiana University Health Methodist Hospital

Indianapolis, Indiana, United States, 46202