NAS Treatment - Opiate Versus Non-Opiate

Neonatal Abstinence Syndrome Clinical Trial

— NAS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01734551
• Other study ID #: 11-0534
• Status: Active, not recruiting
• Phase: Phase 4
• First received: November 21, 2012
• Last updated: October 20, 2014
• Start date: September 2011
• Est. completion date: December 2014

Study information

• Verified date: October 2014
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 34
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 7 Days

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Neonatal Abstinence Syndrome

Intervention

Drug:
• Morphine
Start at 0.4mg/kg/day (divided every 3-4 hours, given with feeds. Dose may be increased 25% of initial dose until symptoms are stable, up to 1 mg/kg/day. Once stable for 72 hrs, weaning may begin (decrease 10% of max dose, every other day). When total dose is <0.1mg/kg/day, may discontinue.
• Clonidine
Initial dose is 5 mcg/kg/day (divided every 3-4 hrs, given with feeds). Will increase 25% of initial dose every 12-24 hrs until stable, up to 12 mcg/kg/day. Dose is unchanged for 72 hours once stable, then may decrease by 10% every other day. If re-escalation is required, the previous dose may be used with 72 hours for stabilizing.

Locations

Country	Name	City	State
United States	University of Kentucky Medical Center	Lexington	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
University of Kentucky

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Bayley Scales of Infant Development	Bayley measures motor, cognitive, language and behavioral development	1 year and 2 years of life	No
Primary	Duration of treatment	Treatment for NAS started within first 7 days of life, continue until symptoms resolved. Slow decreases in dose are scheduled, and in most cases treatment is discontinued about 1 month after discharge	3 months after discharge from hospital	No
Secondary	Evaluate the neurobehavioral performance scores (NNNS)in both treatment groups	The NNNS is Neonatal Intensive Care Network Neurobehavioral Scale, measures habituation, orientation, self regulation, motor/reflexes, and stress/abstinence scales	5-10 days after treatment starts, and 1 month of age	No