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