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

Objectives: To assess the effect of prescription versus not prescription of the prophylactic antibiotic on clinical outcomes in newborn with transient tachypnea. Design: a triple blind randomized clinical trial. Setting and conduct: The eligible newborns with transient tachypnea who will hospitalized in the Fatemieh Hospital during the study period will be enrolled into the trial. 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%. Intervention group: 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 Control group: Just routine care. Primary outcome: (a) assessing the incidence of pneumonia on the first, second, and third days after intervention through physical examination; (b) assessing the signs of septicemia on the first, second, and third days after intervention through physical examination; (c) assessing the incidence of death on the first, second, and third day after intervention through physical examination Secondary outcome: (a) assessing duration of hospitalization based on medical record at discharge; (b) assessing blood culture on the first, second, and third days after intervention through laboratory test; (c) assessing adverse effect of medications such as renal failure on the first, second, and third days after intervention through laboratory test. 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.

Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences