Clonidine as Adjunct to Morphine for Neonatal Abstinence Syndrome

Study Results

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-30

Study Completion Date

2018-12-12

Brief Summary

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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)

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Detailed Description

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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

Conditions

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Neonatal Abstinence Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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clonidine

Clonidine is started at 6mcg/kg/day and increased to 12 mcg/kg/d for the duration of the study period

Group Type ACTIVE_COMPARATOR

Clonidine

Intervention Type DRUG

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

Placebo

Placebo solution will be given for the duration of the study period

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Clonidine

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

36 Weeks

Maximum Eligible Age

45 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No