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Multi‐centre randomised trial of invasive and less invasive surfactant delivery methods showed similar spirometry results at 5–9 years of age
Author(s) -
Göpel Wolfgang,
Kribs Angela,
Roll Claudia,
Wieg Christian,
Teig Norbert,
Hoehn Thomas,
Welzing Lars,
Vochem Matthias,
Hoppenz Marc,
Bührer Christoph,
Mehler Katrin,
Hubert Mechthild,
Eichhorn Joachim,
Schmidtke Susanne,
Rausch Tanja Katrin,
König Inke Regina,
Härtel Christoph,
Roth Bernd,
Herting Egbert
Publication year - 2022
Publication title -
acta paediatrica
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.772
H-Index - 115
eISSN - 1651-2227
pISSN - 0803-5253
DOI - 10.1111/apa.16499
Subject(s) - medicine , interquartile range , spirometry , confidence interval , randomized controlled trial , pediatrics , intubation , pulmonary surfactant , anesthesia , asthma , physics , thermodynamics
Aim We explored whether subnormal forced expiratory volume within 1 s (FEV 1 ) at 5–9 years of age was lower in children born preterm who received less invasive surfactant administration (LISA) rather than surfactant via an endotracheal tube. Methods The multi‐centre, randomised Nonintubated Surfactant Application trial enrolled 211 preterm infants born at 23–26 weeks of gestation from 13 level III neonatal intensive care units from April 2009 to March 2012. They received surfactant via LISA ( n = 107) or after conventional endotracheal intubation ( n = 104). The follow‐up assessments were carried out by a single team blinded to the group assignments. The main outcome was FEV 1 < 80% of predicted values. Results Spirometry was successful in 102/121 children. The other children died or were lost to follow‐up. Median FEV 1 was 93% (interquartile range 80%–113%) of predicted values in the LISA group and 86% (interquartile range 77–102%) in the control group ( p = 0.685). Rates of FEV 1 < 80% were 11/57 (19%) and 15/45 (33%), respectively, which was an absolute risk reduction of 14% (95% confidence interval −3.1% to 31.2%, p = 0.235). There were no differences in other outcome measures. Conclusion The proportion of children aged 5–9 years with subnormal FEV 1 was not significantly different between the groups.