Clinical trial NCT01734551: NAS Treatment - Opiate Versus Non-Opiate
Official title: Pharmacological Treatment of Neonatal Abstinence Syndrome: Opiate Versus Non-Opiate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Neonatal Abstinence Syndrome
Keywords: Prenatal opiate exposure
neonatal withdrawal
Pharmacologic treatment
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2012-11-27
Enrollment: 31
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Finnegan Neonatal Abstinence Scoring System
timeFrame: 14 days
measure: Duration of Treatment
timeFrame: 120 days
Secondary outcomes:
measure: Neurobehavioral Performance Summary Scores From the Neonatal Intensive Care Unit Network Neurobehavioral Scale (NNNS)
timeFrame: 5-10 days after treatment starts
measure: Bayley Scales of Infant and Toddler Development Third Edition
timeFrame: 1 year of life
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky Medical Center
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Henrietta S Bada, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zankl A, Martin J, Davey JG, Osborn DA. Opioid treatment for opioid withdrawal in newborn infants. Cochrane Database Syst Rev. 2021 Jul 7;7(7):CD002059. doi: 10.1002/14651858.CD002059.pub4.
citation: Bada HS, Sithisarn T, Gibson J, Garlitz K, Caldwell R, Capilouto G, Li Y, Leggas M, Breheny P. Morphine versus clonidine for neonatal abstinence syndrome. Pediatrics. 2015 Feb;135(2):e383-91. doi: 10.1542/peds.2014-2377.