]>
IRCT201609049014N114 IRCT 2016-09-08 Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences The effect of prescription versus not prescription of the prophylactic antibiotic on clinical outcomes in newborn with transient tachypnea The effect of prescription versus not prescription of the prophylactic antibiotic on clinical outcomes in newborn with transient tachypnea: a triple blind randomized clinical trial 2016-08-22 anticipated 100 Complete https://irct.ir/trial/9552 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Randomization: The patients will be randomly assigned to intervention and control groups using block randomization. Blinding: newborns will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. The analyzer will be unaware of the type of interventions. Therefore, the trial will be run as triple blind. 2 Transient tachypnea. Intervention 1: Just routine care. Intervention 2: Routine care plus ampicillin 25 mg/kg 3 times a day for 72 hours and amikacin 10 mg/kg 2 times a day for 72 hours.
public Dr Leila Bahadorbeigi
Fatemieh Hospital, Pasdaran Ave.
Hamadan Iran (Islamic Republic of) +98 81 3828 3939 bahar_liela@yahoo.com Fatemieh Hospital scientific Dr Mohammad Kazem Sabzei
Fatemieh Hospital, Pasdaran Ave
Hamadan Iran (Islamic Republic of) +98 81 3828 3939 mk_sabzehei@yahoo.com Fatemieh Hospital Iran (Islamic Republic of) Inclusion criteria: Neonate with gestational age of 34 to 41 weeks; respiratory distress for at least 4 hours. Exclusion criteria: prenatal or perinatal infection; congenital anomalies; disposal of meconium during delivery; Apgar score of 7 or lower; pneumonia; indication of mechanical ventilation; signs of primary septicemia; need for additional oxygen with pressure more than 40%. 1 day 7 days Both P22.1 Transient tachypnoea of newborn Treatment - Other Treatment - Drugs Just routine care Routine care plus ampicillin 25 mg/kg 3 times a day for 72 hours and amikacin 10 mg/kg 2 times a day for 72 hours Assessing the incidence of pneumonia. Timepoint: on the first, second, and third days after intervention. Method of measurement: through physical examination. Assessing the signs of septicemia. Timepoint: on the first, second, and third days after intervention. Method of measurement: through physical examination. Assessing the incidence of death. Timepoint: on the first, second, and third day after intervention. Method of measurement: through physical examination. Assessing duration of hospitalization. Timepoint: based on medical record. Method of measurement: at discharge. Assessing blood culture. Timepoint: on the first, second, and third days after intervention. Method of measurement: through laboratory test. Assessing adverse effect of medications such as renal failure. Timepoint: on the first, second, and third days after intervention. Method of measurement: through laboratory test. Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences Approved 2016-08-06 Ethics Committee of Hamadan University of Medical Sciences Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave Hamadan Iran (Islamic Republic of)