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20-285 - Treating Babies With Neonatal Opioid Withdrawal Syndrome

Status: open

A Phase II, multicenter, double blind, double dummy, randomized, 2 arms parallel study to evaluate the efficacy, safety and pharmacokinetics of CHF6563 in babies with Neonatal Opioid Withdrawal Syndrome

Treatment for Prevention of Chronic Lung Disease

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This research study is studying buprenorphine (CHF6563) as a treatment for neonatal opioid withdrawal syndrome (NOWS). If the infant has NOWS severe enough to require medical treatment, he/she will be given either buprenorphine or morphine by mouth. The study treatment the infant receives is assigned by chance and the study doctor will not know if the baby is receiving buprenorphine or morphine during the study, and up through the end of the “Study Treatment” period. The infant will be in the hospital for up to 10 weeks, depending on the severity of their NOWS and the length of time it takes to wean off medical treatment. During the study, the study doctor will be monitoring the infant for signs of NOWS and do blood tests and other tests to evaluate how they are doing. The study doctor or nurse will contact the infant's mom once they leave the hospital to check on the health of the baby for 6 weeks. The parents will be asked to bring their infant to the hospital or clinic once they reach 18 months of age for another check-up.

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