RT Journal Article
SR Electronic
T1 Prophylactic surfactant nebulisation for the early aeration of the preterm lung: a randomised clinical trial
JF Archives of Disease in Childhood - Fetal and Neonatal Edition
JO Arch Dis Child Fetal Neonatal Ed
FD BMJ Publishing Group Ltd and Royal College of Paediatrics and Child Health
SP fetalneonatal-2022-324519
DO 10.1136/archdischild-2022-324519
A1 Vincent D Gaertner
A1 Stefan Minocchieri
A1 Andreas D Waldmann
A1 Tobias Mühlbacher
A1 Dirk Bassler
A1 Christoph Martin Rüegger
A1 ,
YR 2022
UL http://fn.bmj.com/content/early/2022/11/24/archdischild-2022-324519.abstract
AB Objective The effect of prophylactic surfactant nebulisation (SN) is unclear. We aimed to determine whether prophylactic SN improves early lung aeration.Design Parallel, randomised clinical trial, conducted between March 2021 and January 2022.Setting Delivery room (DR) of a tertiary neonatal centre in Zurich, Switzerland.Patients Preterm infants between 26 0/7 and 31 6/7 weeks gestationInterventions Infants were randomised to receive positive distending pressure alone or positive distending pressure and additional SN (200 mg/kg; poractant alfa) using a customised vibrating membrane nebuliser. SN commenced with the first application of a face mask immediately after birth.Main outcome measures Primary outcome was the difference in end-expiratory lung impedance from birth to 30 min after birth (∆EELI30min). EELI correlates well with functional residual capacity. Secondary outcomes included physiological and clinical outcomes.Results Data from 35 infants were collected, and primary outcome data were analysed from 32 infants (n=16/group). Primary outcome was not different between intervention and control group (median (IQR): 25 (7–62) vs 10 (0–26) AU/kg, p=0.21). ∆EELI was slightly higher in the intervention group at 6 and 12 hours after birth, particularly in the central areas of the lung. There were no differences in cardiorespiratory and clinical parameters. Two adverse events were noted in the intervention group.Conclusions Prophylactic SN in the DR did not significantly affect ∆EELI30min and showed only minimal effects on lung physiology. Prophylactic SN in the DR was feasible. There were no differences in clinical outcomes.Trial registration number NCT04315636.Data are available upon reasonable request. Deidentified individual participant data will be made available from three months to three years following publication, in addition to study protocols, the statistical analysis plan, and the informed consent form to researchers who provide a methodologically sound proposal, with approval by an independent review committee (“learned intermediary”). Data requestors will need to sign a data access or material transfer agreement approved by USZ. Proposals should be submitted to vincent.gaertner@usz.ch to gain access.