Intra‐tracheal surfactant/budesonide versus surfactant alone: Comparison of two consecutive cohorts of extremely preterm infants

Abstract

Objectives To compare the efficacy of intra‐tracheal (IT) surfactant/budesonide (SB) with that of surfactant alone (S) in reducing the rate of bronchopulmonary dysplasia (BPD) at 36 weeks post‐menstrual age (PMA), we included extremely preterm very low birth weight (VLBW) infants with severe respiratory distress syndrome (RDS) in our tertiary neonatal level of care unit (Padua, Italy). Study Design A retrospective chart review of two cohorts of extremely preterm VLBW neonates (<28+0 gestation weeks, birth weight [BW] < 1500 g) born in two consequent epochs (2017–2018/2018–2019) were compared. The SB group received surfactant (200 mg/kg 1st dose) and budesonide (0.25 mg/kg), while the S group received surfactant alone. Results Among 68 neonates with RDS Grades III–IV, FiO2 ≥ 0.3 within 12 h of life, 18 were included in each group after matching for perinatal, clinical, and laboratory characteristics. IT SB did not affect the rate of BPD (Vermont Oxford Network, Jensen's, and National Institute of Child Health and Human Development BPD Workshop 2018 definitions), death, BPD, or death at 36 weeks PMA. Hypotension requiring inotropic support within the first 5 days was lower in those receiving the combined treatment (p = .03). The SB group had fewer admissions to pediatric ward due to respiratory causes up to 12 months of corrected age (p = .03). Conclusion The preliminary results of this retrospective study suggest that in extremely preterm VLBW infants, IT SB for severe RDS did not affect the incidence of BPD, death, and BPD or death at 36 weeks PMA, compared to surfactant alone. The combined therapy proved to be safe in this population. Further studies are warranted to explore the role of early IT steroids on respiratory morbidity in preterm infants.

Early Physiological and Adrenal Effects of Budesonide Mixed with Surfactant in Large Observational Preterm Cohort Study

“…Based on regression analysis, the increased MAP was attributed more to the budesonide than the Hgb. Increases in MAP in infants receiving budesonide were also found in other trials [2, 29].…”

Use of budesonide associated with a pulmonary surfactant to prevent bronchopulmonary dysplasia in premature newborns – A systematic review

“…2020 15 South Korea Randomized clinical trial Weight <1500g + severe NRDS (radiographic evidence) + Invasive Mechanical Ventilation + FiO2 > 0.5 + absence of Severe or lethal congenital anomalies Endotracheal administration with orogastric tube n = 16 Calfactant 105 mg/kg + budesonide 0.25 mg/kg n = 18 Calfactant105 mg/kg No statistically significant differences between the control and intervention groups. Similar adverse effects in both groups Moschino et al 2021 17 Italy Retrospective cohort Preterm newborns < 28 wk and weight <1500g + FIO2 > 30% + exclusion of preterm newborns < 23 weeks and < 400g - n = 18 Curosurf 200 mg/kg + budesonida 0.25 mg/kg n = 18 Curosurf 200 mg/kg Lower rate of hypotension and less hospital stay in the intervention group. No statistical differences in BPD or mortality between groups.…”

“… Refs. Type of the study Selection Comparability Outcomes Overall Moschino et al 2021 17 Retrospective cohort 2 2 2 6 Kothe et al 2020 16 Retrospective cohort 4 0 3 7 …”

“…However, the study by Moschino et al 17 has a major limitation regarding the number of patients included. The pairing process between the control and intervention groups to reduce potential confounders drastically reduced the number of patients included, reducing the statistical power of the study.…”

Long-term Effects of Intratracheal Budesonide and Surfactant for the Prevention of Bronchopulmonary Dysplasia: A Narrative Review

“…The other three studies are observational studies with historical controls that are thus affected by limitations inherent to the study design and to other biases (including selection, detection, and attrition bias). [28][29][30] The administration of budesonide plus surfactant, compared with surfactant alone, could be associated with several advantages (particularly on BPD severity, ventilator support, PDA, hospital admissions in the first 1-2 y of life) without affecting neurodevelopment. However, we feel that given the abovementioned limitations, the generalizability of the results remains limited and the grade of the evidence low.…”