Efficacy and safety of exogenous surfactant therapy in patients under 12 months of age invasively ventilated for severe bronchiolitis (SURFABRON): protocol for a multicentre, randomised, double-blind, controlled, non-profit trial (original) (raw)
Related papers
Can surfactants affect mortality and morbidity in term infants with respiratory failure?
Turkish Journal of Medical Sciences
Background/aim: We aimed to discuss term infants who are given surfactant due to respiratory disorder according to the underlying etiology, the dose of surfactant administration, and the need for repeated surfactant administration. Materials and methods: In this retrospective study infants hospitalized in the 4th level neonatal intensive care unit during January 2019 and December 2021 and administered surfactant due to respiratory distress were included. Term infants given surfactant due to respiratory failure were included in the study through the data recording system. The number of surfactant doses, indications for administration, mortality, duration of hospitalization, intubation time, and inotrope use were recorded in the infants included in the study. Results: During the two-year period, 1250 infants were hospitalized in our neonatal intensive care unit. Of those, 56 infants received surfactant replacement therapy for severe respiratory failure. There were 30 infants with pneumonia, 4 infants with meconium aspiration syndrome (MAS), and 22 infants with transient tachypnea of the newborn (TTN). It was seen that single-dose administration was higher in patients with TTN (p = 0.01), while multiple-dose surfactant administration was more common in patients with MAS, resulting in a statistical difference (p = 0.02). Mortality was lower, especially in cases given early surfactant administration and this situation was statistically significant (p < 0.001). Duration of intubation was 5.05 ± 4.7 days in early surfactant administration group and 8.0 ± 6.1 days in late surfactant administration group. This difference was statistically significant (p = 0.04). While early surfactant application was statistically higher in the TTN group (p = 0.007), late surfactant application was statistically higher in the pneumonia group (p = 0.001). Conclusion: Despite the difference on administration time and repeat dose interval due to etiology, surfactant treatment is improving the respiratory distress of term infants.
Background: Various strategies have been suggested for the treatment of neonatal respiratory distress syndrome (NRDS). Objectives: Nowadays, most of the high-risk pregnancies are successfully ended although they normally result in the delivery of premature and preterm neonates. The rate of NRDS increases in these neonates, which consequently demands for more interventions to save them. Methods: This was a case-control study in which, 52 neonates of 27-32 weeks' gestation and birth weight 1000-3000 g were treated with Curosurf (a natural surfactant) and NCPAP (Nasal continuous positive airway pressure) as the case group. The control group consisted of 52 matched neonates untreated with surfactant and NCPAP. Results: Studying 6 common NRDS-induced complications (pneumothorax, pulmonary hemorrhage, chronic lung disease, intra-ventricular hemorrhage, sepsis and patent ductus arteriosus) showed that there were no significant differences between the case and control groups (P > 0.05). Also, there were no significant differences in mortality and ventilator usage rates and duration of hospitalization (P > 0.05). In total, 9 neonates in the case group (17%) and 16 in the control group (30%) died consequently. Conclusions: The results showed that surfactant therapy had no significant effect on mortality and ventilator usage rates, duration of hospitalization, and NRDS-induced complications.
Intensive Care Medicine, 2002
Objective: To determine whether early surfactant administration is superior to selective delayed treatment in terms of improving survival and/or reducing chronic lung disease in extremely premature neonates with respiratory distress syndrome (RDS) treated by high-frequency oscillatory ventilation (HFOV). Design: Prospective randomized clinical trial. Setting: Tertiary neonatal intensive care unit (NICU) in the Perinatology Center of Prague. Patients: Forty-three extremely premature infants who needed artificial ventilation within 3 h after delivery. Interventions: Patients were randomly assigned to either early (n=21) or delayed (n=22) administration of surfactant. All were ventilated by HFOV as the primary mode of ventilation using the high volume strategy aimed at optimizing lung volume. Curosurf at a dose of 100 mg/kg was given as a single bolus via the endotracheal tube within 1 min immediately after intubation in the early group (EARL), or during HFOV only when defined criteria were reached in the delayed (DEL) group. Measurements and results: No differences were noted in demographic data between the two groups. Fewer infants randomized to the EARL group required oxygen use or died at 36 weeks (combined outcome 29% vs 64%, p=0.021), and there was a lower incidence of any intraventricular hemorrhage in this group (43 vs 82%, p=0.008). Conclusions: When compared to delayed dosing, early administration of surfactant followed by HFOV facilitates and accelerates respiratory stabilization during the acute phase of severe RDS, may reduce the incidence of chronic lung disease or death and may positively influence the incidence of severe intracranial pathology in extremely premature infants with primary surfactant insufficiency.
Early surfactant therapy and noninvasive ventilation
Journal of Perinatology, 2007
Respiratory distress syndrome (RDS) is the most common respiratory morbidity in very low birth weight (VLBW) preterm infants. Surfactant therapy is the standard care for infants with RDS. Natural surfactants appear to be better than synthetic surfactants for RDS treatment. Lung injury remains an important cause of morbidity among VLBW infants despite current treatments. Barotrauma, volutrauma or oxygen-induced lung inflammation contributes to the development of bronchopulmonary dysplasia (BPD). Observational studies using noninvasive ventilation, such as, nasal continuous positive pressure (NCPAP) show a decrease in BPD when used to avoid intubation or minimize the duration of mechanical ventilation via endotracheal tube. Recently, nasal intermittent positive pressure ventilation (NIPPV) has been shown to decrease post-extubation failures significantly compared to NCPAP and has demonstrated a trend toward reduced risk of BPD. The administration of early surfactant followed by noninvasive ventilation has also been shown to improve pulmonary outcomes.
Early versus Delayed Selective Surfactant Treatment for Neonatal Respiratory Distress Syndrome
Neonatology, 2013
not specifically for surfactant dosage) within the first 2 h of life versus delayed selective surfactant administration to infants with established RDS were considered for review. Data Collection and Analysis: Data regarding clinical outcomes were excerpted from the reports of the clinical trials by the review authors. Subgroup analyses were performed based on type of surfactant preparation, gestational age, and exposure to prenatal steroids. Data analysis was performed in accordance with the standards of the Cochrane Neonatal Review Group. Main Results: Six randomized controlled trials met selection criteria. Two of the trials utilized synthetic surfactant (Exosurf Neonatal) and four utilized animal-derived surfactant preparations. The meta-analyses demonstrate significant reductions in the risk of neonatal mortality (typical risk ratio (RR) 0.84; 95% confidence interval (CI) 0.74-0.95; typical risk difference (RD)-0.04; 95% CI-0.06 to-0.01; 6 studies; 3,577 infants), chronic lung disease (typical RR 0.69; 95% CI 0.55-0.86; typical RD-0.04; 95% CI-0.06 to-0.01; 3 studies; 3,041 infants), and chronic lung disease or death at 36 weeks (typical RR 0.83; 95% CI 0.75-0.91; typical RD-0.06; 95% CI-0.09 to-0.03; 3 studies; 3,050 infants) associated with early treatment of intubated infants with RDS. Intubated infants randomized to early selective surfactant administration also demonstrated a decreased risk of acute lung injury including a decreased risk of pneumothorax (typical RR 0.69; 95% CI 0.59-0.82; typical RD-0.05; 95% CI-0.08 to-0.03; 5 studies; 3,545 infants), pulmonary interstitial emphysema (typical RR 0.60; 95% CI 0.41-0.89; typical RD-0.06; 95% CI-0.10 to-0.02; 3 studies; 780 infants), and overall air leak syndromes (typical RR 0.61; 95% CI 0.48-0.78; typical RD-0.18; 95% CI-0.26 to-0.09; 2 studies; 463 infants). A trend
Archives of Disease in Childhood, 1993
A randomised trial was conducted in 82 centres using the porcine surfactant extract, Curosurf, to compare two regimens of multiple doses to treat infants with respiratory distress syndrome and arterial to alveolar oxygen tension ratio <0-22. Infants were randomly allocated to a low dosage group (100 mg/kg initially, with two further doses at 12 and 24 hours to a maximum cumulative total of 300 mg/kg; n=1069) or a high dosage group (200 mg/kg initially with up to four further doses of 100 mg/kg to a maximum cumulative total of 600 mg/kg; n=1099). There was no difference between those allocated low and high dosage in the rates of death or oxygen dependency at 28 days (51.1% v 50/8%; difference -0.3%, 95% confidence interval (CI) -4X6% to 3.9%), death before discharge (25-0% v 23S5%; difference -15/5% 95% CI -5/1% to 2-2%), and death or oxygen dependency at the expected date of delivery (32/2% v 3100%; difference -1.2%/ 95% CI -5/2% to 2.7%). For 14 predefined secondary measures of clinical outcome there were no significant differences between the groups but the comparison of duration of supplemental oxygen >40% did attain significance; 48-4% of babies in the low dose group needed >40% oxygen after three days compared with 42.6% of those in the high dose group.