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NAS Treatment - Opiate Versus Non-Opiate

Information source: University of Kentucky
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Neonatal Abstinence Syndrome

Intervention: Morphine (Drug); Clonidine (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: University of Kentucky

Official(s) and/or principal investigator(s):
Henrietta S Bada, MD, Principal Investigator, Affiliation: University of Kentucky


The purpose of this study is to compare two different medicines to treat babies with opiate withdrawal. The treatment medicines are morphine, which is an opiate, and clonidine, a non-opiate. Morphine is a narcotic medicine, with is included in most pain killers. Clonidine is another drug, but is different from morphine. It is also used for babies, and even adults for withdrawal symptoms. Both drugs are effective, but the purpose of this study is to see if one may be better than the other.

Clinical Details

Official title: Pharmacological Treatment of Neonatal Abstinence Syndrome: Opiate Versus Non-Opiate

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Duration of treatment

Secondary outcome: Evaluate the neurobehavioral performance scores (NNNS)in both treatment groups

Detailed description: Withdrawal from drugs, called Neonatal abstinence syndrome (NAS), is a group of symptoms that occurs to babies whose mother took or used drugs (prescription, addicting, illegal, pain pills, or drugs for addiction treatment) during pregnancy. Medicines the mother takes while pregnant, the baby also takes. Babies may experience withdrawal after delivery, and

may need treatment. There are different ways to treat babies with withdrawal - about 50% of

doctors use morphine, an opiate, to treat these babies, the rest uses other drugs, like clonidine and phenobarbitol.


Minimum age: N/A. Maximum age: 7 Days. Gender(s): Both.


Inclusion Criteria:

- Admitted to Neonatal Intensive Care Unit (NICU)- Gestational age (GA) >or= 35 wks

- Known prenatal opiate exposure (maternal history, positive opiate screen, positive

neonatal urine or meconium screen)

- Symptomatic with Finnegan Neonatal Abstinence Scores meeting NICU protocol for

treatment Exclusion Criteria:

- Seizures

- Major congenital malformations

- Unlikely to survive

- Parents not able to understand English

Locations and Contacts

University of Kentucky Medical Center, Lexington, Kentucky 40536, United States
Additional Information

Starting date: September 2011
Last updated: October 20, 2014

Page last updated: August 20, 2015

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