NAS Treatment - Opiate Versus Non-Opiate
This trial is active, not recruiting.
|Condition||neonatal abstinence syndrome|
|Sponsor||University of Kentucky|
|Start date||September 2011|
|End date||December 2014|
|Trial size||34 participants|
|Trial identifier||NCT01734551, 11-0534|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
Duration of treatment
time frame: 3 months after discharge from hospital
Evaluate the neurobehavioral performance scores (NNNS)in both treatment groups
time frame: 5-10 days after treatment starts, and 1 month of age
Male or female participants up to 7 days old.
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
|Official title||Pharmacological Treatment of Neonatal Abstinence Syndrome: Opiate Versus Non-Opiate|
|Principal investigator||Henrietta S Bada, MD|
|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.|
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