Yeh et al. 20081313 Yeh TF, Lin HC, Chang CH, Wu TS, Su BH, Li TC, et al. Early intratracheal instillation of budesonide using surfactant as a vehicle to prevent chronic lung disease in preterm infants: a pilot study. Pediatrics. 2008;121:e1310-8.
|
Taiwan/USA |
Randomized clinical trial, double-blinded, controlled (pilot study) |
Weight < 1500g
+ severe NRDS
+ Invasive Mechanical Ventilation
+ FiO2 ≥ 0.6
+ absence of severe congenital anomalies or lethal
cardiopulmonary disorder
|
After intubation |
n = 60 Budesonide 0.25 mg/ kg + Survanta 100 mg/kg |
n = 56 Beractant 100 mg/kg |
Intervention: Fewer patients receiving mechanical ventilation at 1st and 2nd weeks in the intervention group (p = 0.001 and p = 0.015, respectively). Reduction in death and BPD (combined) (p = 0.003).
Similar adverse effects in both groups
|
Yeh et al. 20161212 Yeh TF, Chen CM, Wu SY, Husan Z, Li TC, Hsieh WS, et al. Intratracheal administration of budesonide/surfactant to prevent bronchopulmonary dysplasia. Am J Respir Crit Care Med. 2016;193:86-95.
|
Taiwan/USA |
Randomized clinical trial, double-blinded, controlled |
Weight <1500g
+ severe NRDS (radiographic evidence)
+ Invasive Mechanical Ventilation
+ FiO2 ≥ 0.5
+ absence of severe congenital anomalies or lethal
cardiopulmonary disorder
|
After intubation |
n = 131 Budesonide 0.25 mg/ kg + Beractant 100 mg/kg |
n = 134 Beractant 100 mg/kg |
Intervention: Reduction in the incidence of death or BPD (RR 0.58; CI 95% 0.44 - 0.77; p < 0.001). NNT4.1 (CI 95% 2.8 - 7.8) Reduction in BPD (RR 0.70; CI 95% 0.56 - 0.86; p < 0.001), NNT4.7 Lower levels of IL - 1, IL - 6 and IL - 8 (median) in the tracheal aspirate. Similar adverse effects in both groups |
Gharehbaghi et al. 20211414 Gharehbaghi MM, Ganji S, Mahallei M. A randomized clinical trial of intratracheal administration of surfactant and budesonide combination in comparison to surfactant for prevention of bronchopulmonary dysplasia. Oman Med J. 2021;36:e289.
|
Iran |
Randomized clinical trial, double-blinded, controlled |
Preterm newborns < 30 wk and weight <1500g
+ NRDS with indication of surfactant replacement (CPAP 5 FiO2 > 30% or indication for intubation)
INSURE
|
n = 64 Poractant alfa 200 mg/ kg + budesonide 0.25 mg/kg |
n = 64 Poractant alfa 200 mg/ kg |
Intervention: |
Reduction in BPD (p = 0.04), fewer administration of second dose of surfactant (p = 0.01), shorter duration of invasive mechanical ventilation (p = 0.006). Similar adverse effects in both groups |
Heo M, Jeon GW. 20201515 Heo M, Jeon GW. Intratracheal administration of budesonide with surfactant in very low birth weight infants to prevent bronchopulmonary dysplasia. Turk J Pediatr. 2020;62:551-9.
|
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 Calfac-tant105 mg/ kg |
No statistically significant differences between the control and intervention groups. Similar adverse effects in both groups |
Moschino et al. 20211717 Moschino L, Nardo D, Bonadies L, Stocchero M, Res G, Priante E, et al. Intra-tracheal surfactant/budesonide versus surfactant alone: Comparison of two consecutive cohorts of extremely preterm infants. Pediatr Pulmonol. 2021;56:2114-24.
|
Italy |
Retrospective cohort |
Preterm newborns < 28 wk andweight <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.
|
Kothe et al. 20201616 Kothe TB, Sadiq FH, Burleyson N, Williams HL, Anderson C, Hillman NH. Surfactant and budesonide for respiratory distress syndrome: an observational study. Pediatr Res. 2020;87:940-5.
|
USA |
Retrospective cohort |
Weight ≤ 1250g
+ CPAP 5 FiO2 21%
or
intubation in delivery room + exclusion of preterm newborns < 23 weeks and < 500g
|
- |
n = 173
Budesonide 0.25 mg/ kg + Beractant 100 mg/kg
|
n = 294 Beractant 100 mg/kg |
Fewer patients in the intervention group on invasive mechanical ventilation on days 3, 7 and 28. Lower BPD severity in the intervention group.
Lower rate of PCA with repercussions in the budesonide group. No statistical differences in BPD or mortality between groups.
|