Evaluating the Need for Prophylactic Antibiotic Therapy in Infants with Transient Tachypnea of the Newborn: A Triple-Blind Randomized Clinical Trial Study


1 Department of Pediatrics, Hamadan University of Medical Sciences, Hamadan, IR Iran.

2 Department of Epidemiology, School of Public Health, Hamadan University of Medical Sciences, Hamadan, IR Iran.


Transient tachypnea of the newborn (TTN) is a respiratory disorder caused by delay in the evacuation of the lung fluids. Prophylactic antibiotic therapy is recommended for the risk of sepsis. We aimed to evaluate the effect of the prophylactic antibiotic in infants with TTN.
Materials and Methods
This randomized clinical trial study was conducted on all infants, admitted to TTN at Fatemiyeh Hospital, Hamadan, Iran, in 2017. Infants with TTN were randomly stratified into two groups based on whether they received antibiotic or not. Then, the clinical outcomes and laboratory results were examined in the two groups.The categorical data were compared with Chi-square test and the continuous data with t-test using Stata software version 14.0.
Out of 100 term and late preterm infants were admitted to TTN.No significant difference was found between two groups in terms of gender (p = 0.228), gestational age (p = 0.728), birth weight (p = 0.974)and other baseline characteristics. Results revealed that no case of sepsis, pneumonia and death were seen in the group received prophylactic antibiotic and the other group did not receive it, but the admission time was lower in infants, who did not receive antibiotic (137.76 ±32.42  versus 159.36± 33.85, p= 0.001).
This study showed that antibiotic prescription in TTNs infants without perinatal risk factors has no impact on the disease outcome, and prophylactic antibiotic can be avoided.However, more evidence based on large sample size is required.