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Abstract
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 gestation
Interventions 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.
- intensive care units, neonatal
- neonatology
- resuscitation
Data availability statement
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.
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Data availability statement
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.
Footnotes
Collaborators SUNSET study group: David Glauser, Marianne Hauff, Leonie Plastina, Tanja Restin, Janine Thomann and Sandra Ziller (all Newborn Research Zurich, Department of Neonatology, University Hospital Zurich, Switzerland).
Contributors VDG conceptualised and designed the study, recruited patients, collected data, analysed the data, wrote the initial draft of the manuscript and reviewed and revised the manuscript. SM helped to conceptualise and design the study, and critically reviewed the manuscript for important intellectual content. TM recruited patients, collected data and critically reviewed the manuscript for important intellectual content. DB helped to conceptualise and design the study, and critically reviewed the manuscript for important intellectual content. CMR conceptualised and designed the study, recruited patients, collected data, coordinated and supervised data collection, and critically reviewed the manuscript for important intellectual content. David Glauser, Marianne Hauff, Leonie Plastina, Tanja Restin, Janine Thomann and Sandra Ziller assisted in data collection and critically reviewed the manuscript for important intellectual content. All authors approved the final manuscript as submitted and agree to be accountable for all aspects of the work. VDG acts as the guarantor of the work.
Funding VDG was supported by the European Society for Pediatric Research, the Heuberg-Foundation and the SwissLife Foundation. TM was supported by the Anna-Müller-Grocholski Foundation. JT was supported by a Filling The Gap Grant of the University of Zurich. CMR was supported by the EMDO foundation.
Competing interests The nebulisers were provided free of charge by PARI Pharma and the EIT monitor and belts were provided by SenTec AG.
Provenance and peer review Not commissioned; externally peer reviewed.
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