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Optimal Morphine Dosing Schedule for Neonatal Abstinence Syndrome

NCT04298853 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2022-10-06

Study results available
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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

Interventions

DRUG

Morphine PRN

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

DRUG

Morphine scheduled

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

Sponsors & Collaborators

  • Indiana University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
28 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-30
Primary Completion
2021-10-01
Completion
2021-10-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04298853 on ClinicalTrials.gov