Clonidine as Adjunct to Morphine for Neonatal Abstinence Syndrome

January 26, 2023 updated by: kunal gupta, Hennepin County Medical Center, Minneapolis

Clonidine as Adjunct to Morphine in the Management of Term and Near Term Infants With Neonatal Abstinence Syndrome

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)

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Neonatal abstinence syndrome (NAS) is an emerging epidemic and has lead to a tremendous increase in cost of medical care. Opioids are the mainstay of treatment for NAS although there are concerns about possible short-term and long-term effects including but not limited to adverse neurodevelopmental outcomes. Other drugs such as clonidine, phenobarbitone, methadone and buprenorphine have been evaluated to limit the postnatal exposure to opioids in these infants. Clonidine is an alpha 2 receptor and can lessen withdrawal manifestations. The addition of clonidine at 6 µg/kilogram/day to morphine in the management of NAS has been shown to reduce the duration of pharmacotherapy by about 27% in a previous study.

A recent pilot study reported reduction of treatment duration for NAS with clonidine (12 µg/kilogram/day) monotherapy as compared to morphine monotherapy. The study reported no adverse effects in study subjects at the doses used in the study. The investigators hypothesize that there will be a minimum of 30% reduction in the treatment duration with 12 µg/kilogram/day clonidine used as adjuncts to standard morphine treatment as compared to morphine monotherapy in the management of term and near term infants with NAS

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55415
        • Hennepin County Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 months to 10 months (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Requiring neonatal intensive care unit (NICU) admission for management of neonatal abstinence syndrome
  • Gestational age greater than or equal to 36 weeks
  • Less than or equal to 48 hours of treatment with morphine for NAS

Exclusion Criteria:

  • Presence of seizures
  • Congenital malformations, genetic syndromes or the presence of TORCH infections
  • Major medical problems
  • Heart rate and/or blood pressure instability

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: clonidine
Clonidine is started at 6mcg/kg/day and increased to 12 mcg/kg/d for the duration of the study period
Drug: Clonidine
clonidine will be given at 12 mcg/kg/d to the experimental arm in addition to oral morphine
PLACEBO_COMPARATOR: Placebo
Placebo solution will be given for the duration of the study period
Drug: Placebo
Placebo with volume similar to clonidine at 12 mcg/kg/d will be given to this arm in addition to oral morphine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of Pharmacotherapy for NAS
Time Frame: From beginning of morphine therapy during NICU admission until discharge from the hospital, up to 100 days
The length of time in days from the initiation of pharmacotherapy on day 1 until the medication has been stopped
From beginning of morphine therapy during NICU admission until discharge from the hospital, up to 100 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of Hospital Stay
Time Frame: From beginning of morphine therapy during NICU admission until discharge from the hospital, up to 100 days
Number of days spent in the hospital
From beginning of morphine therapy during NICU admission until discharge from the hospital, up to 100 days
Maximum Dose of Morphine Used
Time Frame: From beginning of morphine therapy during NICU admission until discharge from the hospital, up to 100 days
The maximum dose of morphine in mg/kg used for symptom control
From beginning of morphine therapy during NICU admission until discharge from the hospital, up to 100 days
Average Daily Dose of Oral Morphine Over Hospital Stay
Time Frame: From beginning of morphine therapy during NICU admission until discharge from the hospital, up to 100 days
The average daily dose of morphine used throughout study period in mg/kg/day
From beginning of morphine therapy during NICU admission until discharge from the hospital, up to 100 days
Total Number of Episodes of Heart Rate Variability (Heart Beats/Min)
Time Frame: From beginning of morphine therapy during NICU admission until discharge from the hospital, up to 100 days
Number of episodes of bradycardia (Heart rate < 60/min for a minimum of 20 seconds and not associated with apnea or signs of reflux such as emesis, regurgitation of milk into the mouth or nose, arching while feeding, number of episodes of tachycardia (Heart rate > 200/min) and not related to pain and/or agitation
From beginning of morphine therapy during NICU admission until discharge from the hospital, up to 100 days
Total Number of Episodes of Blood Pressure (mm of Hg) Variability
Time Frame: From beginning of morphine therapy during NICU admission until discharge from the hospital, up to 100 days
Number of episodes of hypotension (blood pressure < 5th percentile for age) and hypertension (blood pressure > 95th percentile for age)
From beginning of morphine therapy during NICU admission until discharge from the hospital, up to 100 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hennepin County Medical Center, Minneapolis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 30, 2018

Primary Completion (ACTUAL)

December 12, 2018

Study Completion (ACTUAL)

December 12, 2018

Study Registration Dates

First Submitted

November 8, 2017

First Submitted That Met QC Criteria

November 30, 2018

First Posted (ACTUAL)

December 3, 2018

Study Record Updates

Last Update Posted (ACTUAL)

February 10, 2023

Last Update Submitted That Met QC Criteria

January 26, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NAS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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