NAS Treatment - Opiate Versus Non-Opiate

Henrietta Bada

Status and phase: Completed; Phase 4

Conditions: Neonatal Abstinence Syndrome

Treatments: Drug: Morphine; Drug: Clonidine

Study type: Interventional

Funder types: Other

Identifiers

NCT01734551

11-0534

Details and patient eligibility

About

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.

Full 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.

Enrollment: 31 patients

Sex: All

Ages: 1 to 7 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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31 participants in 2 patient groups

Morphine

Active Comparator group

Description:

Initial dose is 0.4mg/kg/day, divided every 3-4 hours, given PO with feeds. Drug is required until symptoms of withdrawal no longer cause the infant feeding, behavior, or elimination problems, up to 3 months.

Treatment:

Drug: Morphine

Clonidine

Active Comparator group

Description:

Dose is started at 5 mcg/kg/day, given PO with feeds, divided every 3-4 hours. Drug is required until symptoms of withdrawal no longer cause the infant feeding, behavior, or elimination problems, up to 3 months.

Treatment:

Drug: Clonidine