The impact of combined administration of surfactant and intratracheal budesonide compared to surfactant alone on bronchopulmonary dysplasia and mortality rate in preterm infants with respiratory distress syndrome: a single-blind randomized clinical trial

• Published in: BMC Pediatrics 2024, Vol.24 (1)
• Main Authors: Marzban, Asghar, Mokhtari, Samira, Tavakkolian, Pouria, Mansouri, Reza, Jafari, Nahid, Maleki, Azam
• Format: Report
• Language: English
• Subjects: Bronchopulmonary dysplasia; Care and treatment; Complications and side effects; Development and progression; Dosage and administration; Infants (Premature); Respiratory distress syndrome; Risk factors; Surface active agents
• ISSN: 1471-2431; 1471-2431
• DOI: 10.1186/s12887-024-04736-9

Respiratory distress syndrome (RDS) is one of the most important and common disorders among premature infants. This study aimed to compare the effect of the combination of surfactant and budesonide with surfactant alone on Bronchopulmonary dysplasia (BPD) and mortality rate among premature infants with RDS. An outcome assessor-blind randomized clinical trial was conducted on 134 premature infants with RDS who were born in Ayatollah Mousavi Hospital, Zanjan, Iran in 2021. The covariate adaptive randomization method was utilized to allocate participants into two groups (surfactant alone and a combination of surfactant and budesonide). The primary outcomes were BPD and Mortality rate from admission to hospital discharge. The data in this study were analyzed using SPSS software version 18. Overall the comparison of mortality rate and BPD between the two groups did not show a significant difference(p > 0.05). The subgroup results showed that administering surfactant with budesonide to infants under 30 weeks of age significantly reduced the number of deaths compared to using surfactant alone (5 vs. 17). Similar positive effects were observed for the occurrence of Pulmonary Hemorrhage, the need for a second dose of surfactant, oxygen index, mean blood pressure and mean arterial pressure (MAP) in infants under 34 weeks of age compared to more than 34 weeks (p < 0.05). These findings suggest that the combination therapy of surfactant and budesonide may be beneficial, particularly in preterm infants with less than 34 weeks gestational age and 1500 birth weight. However, further studies with larger sample sizes and longer follow-up periods are needed to confirm these results and assess long-term outcomes.