Clonidine as Adjunct to Morphine for Neonatal Abstinence Syndrome

Neonatal Abstinence Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03762317
• Other study ID #: NAS
• Status: Terminated
• Phase: Phase 4
• Start date: April 30, 2018
• Est. completion date: December 12, 2018

Study information

• Verified date: January 2023
• Source: Hennepin County Medical Center, Minneapolis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: December 12, 2018
• Est. primary completion date: December 12, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 36 Weeks to 45 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Neonatal Abstinence Syndrome
• Syndrome

Intervention

Drug:
• Clonidine
clonidine will be given at 12 mcg/kg/d to the experimental arm in addition to oral morphine
• Placebo
Placebo with volume similar to clonidine at 12 mcg/kg/d will be given to this arm in addition to oral morphine

Locations

Country	Name	City	State
United States	Hennepin County Medical Center	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Hennepin County Medical Center, Minneapolis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of Pharmacotherapy for NAS	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	Duration of Hospital Stay	Number of days spent in the hospital	From beginning of morphine therapy during NICU admission until discharge from the hospital, up to 100 days
Secondary	Maximum Dose of Morphine Used	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
Secondary	Average Daily Dose of Oral Morphine Over Hospital Stay	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
Secondary	Total Number of Episodes of Heart Rate Variability (Heart Beats/Min)	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
Secondary	Total Number of Episodes of Blood Pressure (mm of Hg) Variability	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