MedTrace Logo

Clonidine as Adjunct to Morphine for Neonatal Abstinence Syndrome

NCT03762317 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2023-02-10

Study results available
· View outcomes & findings →

Summary

This is a prospective randomized double blinded study comparing the effect on duration of pharmacologic treatment and duration of hospital stay when using clonidine at 12 µg/kilogram/day as an adjunct to oral morphine as compared to morphine monotherapy in the management of term and near term infants with neonatal abstinence syndrome (NAS)

Conditions

  • Neonatal Abstinence Syndrome

Interventions

DRUG

Clonidine

clonidine will be given at 12 mcg/kg/d to the experimental arm in addition to oral morphine

DRUG

Placebo

Placebo with volume similar to clonidine at 12 mcg/kg/d will be given to this arm in addition to oral morphine

Sponsors & Collaborators

  • Hennepin County Medical Center, Minneapolis

    lead OTHER

Principal Investigators

  • kunal gupta · Hennepin County Medical Center, Minneapolis

  • vinay sharma · Hennepin County Medical Center, Minneapolis

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
36 Weeks
Max Age
45 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-30
Primary Completion
2018-12-12
Completion
2018-12-12
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT03762317 on ClinicalTrials.gov