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Treatment of Neonatal Abstinence Syndrome With Clonidine Versus Morphine as Primary Therapy

NCT03092011 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2024-10-15

No results posted yet for this study

Summary

The purpose of this study is to show non-inferiority between two medications used for medical treatment of withdrawal seen in Neonatal Abstinence Syndrome (NAS), Clonidine and Morphine Sulfate (used in routine care) on length of treatment for NAS .

Conditions

  • Neonatal Abstinence Syndrome

Interventions

DRUG

Clonidine

Clonidine at 0.38 mcg/kg/dose every 3 hours or 0.5 mcg/kg/dose every 4 hours Clonidine dose will be increased by 25% of the previous dose if needed. It will be decreased by 10% of the highest dose using the original/birth weight (same amount each time) every 24 to 48 hours, provided the scores remain below 8.

DRUG

Morphine Sulfate

Morphine at 0.03 mg/kg/dose every 3 hours or 0.04 mg/kg/dose every 4 hours Morphine dose will be increased by 25% of the previous dose if needed. It will be decreased by 10% of the highest dose using the original/birth weight (same amount each time) every 24 to 48 hours, provided the scores remain below 8.

Sponsors & Collaborators

  • The Cooper Health System

    lead OTHER

Principal Investigators

  • Alla Kushnir, MD · The Cooper Health System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Max Age
10 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-21
Primary Completion
2024-10-01
Completion
2026-12-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT03092011 on ClinicalTrials.gov