Clonidine as Adjunct Therapy for the Treatment of Neonatal Abstinence Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-07-31

Study Completion Date

2005-12-31

Brief Summary

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To test the hypothesis that the combination of the tincture of opium (DTO) and clonidine will be more effective in treating infants with neonatal abstinence syndrome (opioid withdrawal) than tincture of opium (DTO) alone.

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Detailed Description

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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

DOUBLE

Study Groups

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Clonidine treatment

Infants intrauterine exposed to opioids (heroin or methadone) that demonstrate signs and symptoms of withdrawal with withdrawal scores (modified Finnegan score) greater than 9 on to consecutive scores taken 4 hours apart.

Group Type EXPERIMENTAL

Clonidine HCL

Intervention Type DRUG

Duraclon 1 microgram/kg every 4 hours given p.o. as per algorithm

Interventions

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Clonidine HCL

Duraclon 1 microgram/kg every 4 hours given p.o. as per algorithm

Intervention Type DRUG

Other Intervention Names

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Duraclon

Eligibility Criteria

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Exclusion Criteria

* \< 35 weeks gestational age
* Intrauterine growth retardation defined as \<5%tile of gestational age
* postnatal treatment with barbiturates or benzodiazepines,
* major congenital anomalies
* major concomitant medical illness requiring oxygen therapy, intravenous fluids or medications.
* breastfed infants

Maximum Eligible Age

14 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No