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IRCT20181231042183N1 IRCT 2019-01-18 Birjand University of Medical Sciences Assessment Effect of Bopronorphin Neonates With Obstinence Syndrom BBS Comparison Bopronorphin and Morphin Among NeonatesWith Obstinence Syndrom Admitted In Birjand Vali-asr Hospital 2018-12-22 anticipated 60 Complete https://irct.ir/trial/36431 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple Randomization SingleRandomization Seal Envelop The Hidden Drug in 2 Group of Morphin and Bupronorphin in C and D Solution Randomized Use for Treatment and Nature of Solution is Unclear, Blinding description: Morphin and Bupronorphin are in 2Container of C and D with Same Color and Apperance and Stained. All Participant and Researchers and Physician and Nurse and Data Analyser are Unaware of Ordered Drug. 3 Neonatal Abstinence Syndrome. Intervention 1: Intervention group: Randomized clinical trial study in 60 neonate. 2 group of neonatal abstinence syndrome that randomized divided to 2 group of Buprenorphine (intervention group 30 neonate) and Morphin group (control group 30 neonate).Treat initiation is according to Fingan scoring system. According to enough Fingan scoring medical treatment prescribe. Drugs prescribe is according randomize method. Drugs have same appearance and volume and container and medical group are unexplained about type of drug. A tablet 2 mgr of Bupronorphin (Pharan Shimi® group) dilute in 50 cc water and prescribe in intervention group. Bupronorphin(Intervention group) initiation dose is 0.075 mg/kg/day in 6 divided dose. Drug dose adjust base on number of Fingan score in each assess. If Fingan score be more than 12, the next dose decrease %10 of previous dose. If Fingan score be less than 8, continously drug dose decrease by %10. After each 8 hours of symotoms control (Fingan score 8 to 12), decreasing %10 of maximum dose per day. If minimum dose of drug be under 0.1 mg/kg/day Bupronorphin stop and neonate monitor for each 8 hour and discharge. Intervention 2: Control group: Randomized clinical trial study in 60 neonate. 2 group of neonatal abstinence syndrome that randomized divided to 2 group of Buprenorphine (intervention group 30 neonate) and Morphin group (control group 30 neonate).Treat initiation is according to Fingan scoring system. According to enough Fingan scoring medical treatment prescribe. Drugs prescribe is according randomize method. Drugs have same appearance and volume and container and medical group are unexplained about type of drug. 1 cc Morphin dilute in 24 cc water and prescribe in control group. Morphin (control group) initiation dose is 0.4 mg/kg/day in 6 divided dose. Drug dose adjust base on number of Fingan score in each assess. If Fingan score be more than 12, the next dose decrease %10 of previous dose. If Fingan score be less than 8, continously drug dose decrease by %10. After each 8 hours of symotoms control (Fingan score 8 to 12), decreasing %10 of maximum dose per day. If minimum dose of drug be under 0.1 mg/kg/day Morphin stop and neonate monitor for each 8 hour and discharge. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Parent satisfaction needed
public Gholamreza Faal
Ghafari Ave
Birjand Iran (Islamic Republic of) 9717853577 +98 56 3239 5000 s.hajmohamadi@bums.ac.ir Birjand University of Medical Sciences scientific Gholamreza Faal
Ghafari Ave
Birjand Iran (Islamic Republic of) 9717853577 +98 563239500 s.hajmohamadi@bums.ac.ir Birjand University of Medical Sciences Iran (Islamic Republic of) Postnatal Age<7 Days Gestational Age≥ 35 Weeks Prenatal Opium Exposure Symptomatic Patient And 3 Fingan Score ≥8 In 3 Hours Or 2 Fingan Score≥12 No Siezure History No Major Congenital Anomaly No Unstablity In Blood Pressure And Hemodynamic No Major Medical Unstability In Association Of Withdrawal Syndrome 1 day 7 days Both Analgesic Consumption and withdrawal syndrome P96.1 Neonatal withdrawal symptoms from maternal use of drugs of addiction Treatment - Drugs Treatment - Drugs Intervention group: Randomized clinical trial study in 60 neonate. 2 group of neonatal abstinence syndrome that randomized divided to 2 group of Buprenorphine (intervention group 30 neonate) and Morphin group (control group 30 neonate).Treat initiation is according to Fingan scoring system. According to enough Fingan scoring medical treatment prescribe. Drugs prescribe is according randomize method. Drugs have same appearance and volume and container and medical group are unexplained about type of drug. A tablet 2 mgr of Bupronorphin (Pharan Shimi® group) dilute in 50 cc water and prescribe in intervention group. Bupronorphin(Intervention group) initiation dose is 0.075 mg/kg/day in 6 divided dose. Drug dose adjust base on number of Fingan score in each assess. If Fingan score be more than 12, the next dose decrease %10 of previous dose. If Fingan score be less than 8, continously drug dose decrease by %10. After each 8 hours of symotoms control (Fingan score 8 to 12), decreasing %10 of maximum dose per day. If minimum dose of drug be under 0.1 mg/kg/day Bupronorphin stop and neonate monitor for each 8 hour and discharge. Control group: Randomized clinical trial study in 60 neonate. 2 group of neonatal abstinence syndrome that randomized divided to 2 group of Buprenorphine (intervention group 30 neonate) and Morphin group (control group 30 neonate).Treat initiation is according to Fingan scoring system. According to enough Fingan scoring medical treatment prescribe. Drugs prescribe is according randomize method. Drugs have same appearance and volume and container and medical group are unexplained about type of drug. 1 cc Morphin dilute in 24 cc water and prescribe in control group. Morphin (control group) initiation dose is 0.4 mg/kg/day in 6 divided dose. Drug dose adjust base on number of Fingan score in each assess. If Fingan score be more than 12, the next dose decrease %10 of previous dose. If Fingan score be less than 8, continously drug dose decrease by %10. After each 8 hours of symotoms control (Fingan score 8 to 12), decreasing %10 of maximum dose per day. If minimum dose of drug be under 0.1 mg/kg/day Morphin stop and neonate monitor for each 8 hour and discharge. Admit Duration. Timepoint: Duration of Admit. Method of measurement: Observation of physician. Drugs Complications. Timepoint: Admit Duration. Method of measurement: Observation of physician. Apnea. Timepoint: Admit Duration. Method of measurement: Observation of physician. Feeding. Timepoint: Admit Duration. Method of measurement: Observation of physician. Blood Pressure. Timepoint: Admit Duration. Method of measurement: Mercurial Pressure-Gauge Device. Birjand University of Medical Sciences Approved 2018-10-15 Ethics committee of Birjand University of Medical Sciences Ghafari Ave., Valiasr Hospital Birjand South Khorasan Iran (Islamic Republic of)