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IRCT20120614010026N10 IRCT 2018-01-14 Esfahan University of Medical Sciences The effect of Erythromycin on feeding intolerance in premature infants erythromycin Evaluating the effect of intermediate dose of oral Erythromycin on feeding intolerance in premature infants 2016-03-20 anticipated 84 Complete https://irct.ir/trial/10527 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Table of random numbers, Blinding description: The syringes of Erythromycin and distilled water are similar in appearance, color and cover. A trained nurse who is not participated in this study, numbered syringes and give them to this study colleague. The colleague divided these syringes among neonates without knowing a bout content of syringe. 3 feeding intolerance. Intervention 1: in intervention group: erythromycin syrup, 20 mg/kg/ day, every 6 hours. for 8 days in control group: distilled water, 20 cc/kg/day, every 6 hours, for 8 days. Intervention 2: Control group: distilled water equal volume of erythromycin for 8 days. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information
public Amir-mohammad Armanian
Alzahra Hospital, Shohadaye Sofe Street, Isfahan City, Iran Country
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3621 0008 armanian@med.mui.ac.ir Esfahan University of Medical Sciences scientific Amir-mohammad Armanian
Alzahra Hospital, Shohadaye Sofe Street, Isfahan City, Iran Country
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3621 0008 armanian@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) premature infants weight lower than 1800 grams feeding volume less than 75 cc/kg/ day in the 14th day after birth frequent lavage (i.e. => 2 times lavage; >50% of milk volume) parents willingness 14 days 1 month Both presence of sepsis gastrointestinal anomalies cyanotic heart disease history of operation on gastrointestinal system in the first 14 days after birth consumption of medication effective in erythromycin metabolism in the same time incidence of arrhythmia or prolonged QT interval parents unwillingness p92.3 Underfeeding of newborn Treatment - Drugs Treatment - Drugs in intervention group: erythromycin syrup, 20 mg/kg/ day, every 6 hours. for 8 days in control group: distilled water, 20 cc/kg/day, every 6 hours, for 8 days Control group: distilled water equal volume of erythromycin for 8 days Time duration to reach to 75, 110 and 150 cc/kg/ day feeding volume. Timepoint: daily, during intervention. Method of measurement: observation. Time duration of oxygen dependency. Timepoint: during intervention. Method of measurement: observation. Time duration of hospitalization. Timepoint: during intervention. Method of measurement: observation. Sepsis incidence. Timepoint: during intervention. Method of measurement: physical examination. Necrotizing enterocolitis incidence. Timepoint: during intervention. Method of measurement: physical examination. Esfahan University of Medical Sciences Approved 2016-09-22 Ethics committee of Isfahan university of medical science isfahan, hezar jarib street, isfahan university of medical sciene isfahan Isfehan Iran (Islamic Republic of)