Neonatal Neurology: Clinical Research
Neonatal Neurology 6: Clinical 6
Aayushka Gurung, MD (she/her/hers)
MD
University of South Alabama Children's and Women's Hospital
Daphne, Alabama, United States
Randomized trials have reported that the intratracheal instillation of a suspension of budesonide-surfactant soon after birth may reduce rates of bronchopulmonary dysplasia in extremely preterm (EP) infants. However, the long-term neurodevelopmental (ND) effect of such therapy in EP infants remains unknown.
Objective:
To assess the survival and ND outcomes of EP infants treated with intratracheal instillation of budesonide-surfactant in comparison with surfactant alone.
Design/Methods:
In this retrospective, single-center study, neonates born between January 2010 and October 2020 with a gestational age (GA) of ≤ 28 weeks were included. Infants with major congenital anomalies were excluded. Neonates were separated into two groups: the budesonide-surfactant combination group (budesonide) and the surfactant alone group (control). The primary outcome was a composite of death or neurodevelopmental impairment (NDI). ND outcomes were assessed using the Bayley Scales of Infant-Toddler Development (3rd or 4th edition) at a corrected age of 2 years. NDI was diagnosed if any of the following occurred: cerebral palsy, deafness, blindness, a cognitive composite score < 70, a language composite score < 70, or a motor composite score < 70. The association between budesonide therapy and NDI was adjusted for known risk factors of NDI such as birthweight, Apgar < 5 at 5 minutes, female gender, white matter injury, exploratory laparotomy for perforation, and pulmonary hypertension requiring treatment.
Results:
A total of 600 EP infants (202 in the budesonide group and 398 in the control group) were included. The rates of the primary outcome (death or NDI) in the budesonide group were significantly higher than in the control group (64.9% and 52.1%, respectively; adjusted relative risk (RR) with the budesonide group was 1.22; 95% confidence interval (CI) 1.05-1.40; p = 0.015). While the mortality rate was not different between the two groups, the rate of NDI was increased in the budesonide group as compared to the control group (49.7% vs. 36.9%; adjusted RR with the budesonide group is 1.28; 95% CI 1.01-1.57; p=0.047). Budesonide had the greatest effect on the cognitive and language scores of the NDI. There were no significant differences in the rates of cerebral palsy or the motor composite score < 70 between the two groups.
Conclusion(s):
Intratracheal budesonide-surfactant therapy was associated with an increased likelihood of NDI in EP infants. Further studies are needed to confirm our results.