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IRCT20130311012782N44 IRCT 2020-03-16 Ghoum University of Medical Sciences Evaluation of the efficacy of S-omeprazole alone and with baclofen in the treatment of neonatal reflux Study of the effect of Esomeprazole and combination of Esomeprazole ppus Baclofen in the treatment of clinical signs of infants reflux 2020-04-02 anticipated 50 Complete https://irct.ir/trial/45266 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization of patients between the two intervention groups was done using random Allocation Software. In the mentioned software, the sample size is first entered into software for two groups. Then the number of study groups is entered. At the output of the software, a list of two columns is seen, with numbers 1 to 50 (total sample size) distributed in two columns randomly. Patients are divided into two groups according to the time of referral, which is the first patient number 1 and the last patient number 50, Blinding description: This study is done by double blind method . The blinds included in this study include parents of children and person of responsible for data collection . Parents are unaware of the type of drug they are receiving.Also the drugs is prescribed by the researcher for the patients, but the outcome of the study is evaluated by another pediatrician who is unaware of the type of medication the patient is receiving. 1 Neonatal Reflux. Intervention 1: Intervention group 1: Reflux treatment with Esomeprazole made by Rosa Darou Company as intra capsuls granules 1 mg/kg once daily for two weeks. Intervention 2: Intervention group 2:Treatment of reflux with Esomeprazole as intra capsuls granules made by Roz Darou company, 1 mg / kg daily dose plus baclofen tablet (made by Roz darou company) 0.2 mg / kg once daily for 14 days:. No - There is not a plan to make this available Justification or reason for not sharing IPD is The plan is owned by the government agency and data cannot be published.
public Leila Naderi
No. 83, 4 alley, 1/1 street, Safashahr
Qom Iran (Islamic Republic of) 3713649373 +98 25 3665 1801 fatemeh.naderi2010@yahoo.com Ghoum University of Medical Sciences scientific Hojatollah Jafari
Imam Khomini street, Hazrate Masoumeh hospital
Qom Iran (Islamic Republic of) 3713649373 +98 25 3665 1801 ahw_2704@yahoo.com Ghoum University of Medical Sciences Iran (Islamic Republic of) Range age 3 to 12 months Failure to respond to routine reflux treatments 3 months 12 months Both History of hospitalization in neonatal intensive care unit Birth weight less than 2500 grams Having an underlying disease such as cerebral palsy P78.83 Newborn esophageal reflux Treatment - Drugs Treatment - Drugs Intervention group 1: Reflux treatment with Esomeprazole made by Rosa Darou Company as intra capsuls granules 1 mg/kg once daily for two weeks Intervention group 2:Treatment of reflux with Esomeprazole as intra capsuls granules made by Roz Darou company, 1 mg / kg daily dose plus baclofen tablet (made by Roz darou company) 0.2 mg / kg once daily for 14 days: Newborn esophageal reflux. Timepoint: Before beginning intervention and the end of the first week, second week, first month, second month after intervention. Method of measurement: Investigation of clinical singes. Restlessness. Timepoint: Before beginning intervention and the end of the first week, second week,. Method of measurement: Investigation of clinical singes. Nausea. Timepoint: Before beginning intervention and the end of the first week, second week,. Method of measurement: Investigation of clinical singes. Womitting. Timepoint: Before beginning intervention and the end of the first week, second week,. Method of measurement: Investigation of clinical singes. Respiratory distress. Timepoint: Before beginning intervention and the end of the first week, second week,. Method of measurement: Investigation of clinical singes. Cough. Timepoint: Before beginning intervention and the end of the first week, second week,. Method of measurement: Investigation of clinical singes. Weight loss. Timepoint: Before beginning intervention and the end of the first week, second week,. Method of measurement: Investigation of clinical singes. Ghoum University of Medical Sciences Approved 2019-10-21 Ethics committee of Qom University of Medical Sciences Research faculty, Qom University ofMedical Sciences, Shahi Lavasani street Isfahan Isfehan Iran (Islamic Republic of)