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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.


Clinical Trial 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. ;


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


NCT number NCT01734551
Study type Interventional
Source University of Kentucky
Contact
Status Active, not recruiting
Phase Phase 4
Start date September 2011
Completion date December 2014

See also
  Status Clinical Trial Phase
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Completed NCT01958476 - Improving Outcomes in Neonatal Abstinence Syndrome Phase 3
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Completed NCT02851303 - Morphine Versus Methadone for Opiate Exposed Infants With Neonatal Abstinence Syndrome Phase 4
Recruiting NCT05226624 - The Alberta Neonatal Abstinence Syndrome Mother-Baby Care ImprovEmeNT Program N/A
Completed NCT03670160 - Clonidine Versus Phenobarbital as Adjunctive Therapy for Neonatal Abstinence Syndrome Phase 2
Not yet recruiting NCT04611659 - Averting NAS Among Opioid-Using Young Women Receiving MAT Using Buprenorphine N/A
Completed NCT01452789 - Blinded Trial of Buprenorphine or Morphine in the Treatment of the Neonatal Abstinence Syndrome Phase 3
Completed NCT04588519 - tAN to Mitigate Withdrawal Behaviors in Neonates N/A
Completed NCT02797990 - Conflict Between Maternal Autonomy and Child Health in Substance-use N/A
Completed NCT02801331 - Efficacy and Outcomes of a Non-Pharmacological Intervention for Neonatal Abstinence Syndrome N/A
Terminated NCT03246243 - Quantitative Assessment of Sucking for Early Diagnosis of Brain Injury in Infants at High Risk
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Recruiting NCT06303986 - Study to Collect Data for Neonatal Abstinence Syndrome (NAS) and Evaluate the Automated Data Collection Process
Active, not recruiting NCT03725332 - The PATH Home Trial: A Comparative Effectiveness Study of Peripartum Opioid Use Disorder in Rural Kentucky N/A
Recruiting NCT04983563 - Actigraphy and Neonatal Abstinence Syndrome of Hospitalized Newborn in Intensive Care Units N/A
Completed NCT04298853 - Optimal Morphine Dosing Schedule for Neonatal Abstinence Syndrome Phase 4
Completed NCT02182973 - Donor Human Milk in Neonatal Abstinence Syndrome
Completed NCT02810782 - How to Treat Opiate Withdrawal in Neonates Phase 3