Background Less-invasive surfactant administration (LISA) is increasingly used. We investigated the feasibility of a new LISA-device (Neofact®) in neonates.
Design Prospective observational pilot study with open-label LISA in two tertiary neonatal intensive care units.
Patients 20 infants with a gestational age of ≥26+0/7 weeks and an indication for LISA (Respiratory Severity Score (RSS)≥5 or fraction of inspired oxygen (FiO2) ≥0.30). Infants with respiratory tract malformations or unavailability of an instructed neonatologist were excluded.
Main outcome measures Success of LISA, defined as laryngoscopy-confirmed intratracheal catheter position or a decrease in FiO2 by ≥0.05 or to 0.21, accompanied by an RSS decrease of ≥2; number of attempts needed for tracheal catheterisation.
Results 20/57 screened infants were enrolled. Successful application occurred in 19/20 (95%). One application failed after three attempts. No device-related adverse events occurred. The median number of attempts was 2, success rate per attempt 19/31 (61%).
Conclusion LISA via Neofact® appears feasible.
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Collaborators Neofact® - feasibility Study Group: Coordinating Investigator: Christian A. Maiwald (University Children’s Hospital Tübingen, Department of Neonatology, Tübingen, Germany; corresponding author). Steering Committee: Axel R. Franz, Corinna Engel and Christian F. Poets (University Children’s Hospital Tübingen, Department of Neonatology, Tübingen, Germany); Patrick Neuberger and Matthias Vochem (Olgahospital Stuttgart, Department of Neonatology, Stuttgart, Germany). Data Management, Biometry, Monitoring and Study Coordination: Iris Bergmann, Corinna Engel, Andrea Evers-Bischoff (all at the Center for Pediatric Clinical Studies, University Children’s Hospital Tübingen, Germany). Recruiting Hospitals and Local Investigators: Olgahospital Stuttgart, Department of Neonatology: Patrick Neuberger and Christian Schlunk. University Children’s Hospital Tübingen, Department of Neonatology: Axel R. Franz, Christian Gille, Ingo Müller-Hansen, Jörg Arand, Kerstin Gründler, Karen B. Kreutzer and Nicole Wolf.
Contributors CAM evolved the study protocol under the supervision of AF, PN, MV, CE and CFP;
supervised and gave helpful annotations on request in some of the surfactant administrations in Tuebingen; and drafted the first version of the manuscript. AF and PN acted as local principal investigators. CAM and the local investigators of the study group informed parents and obtained their consent for participation. Surfactant administration was accomplished by all local investigators (excepting CAM). CE and CAM analysed the data. AF, CFP, PN and MV reviewed the manuscript with respect to clinical interpretation of the data. All authors reviewed the manuscript, contributed to each draft version and approved the final version of the manuscript.
Funding This research project was enabled by a research funding from the Lyomark Pharma GmbH. Lyomark Pharma GmbH had no influence in the preparation of data or the manuscript.
Competing interests CAM has a financial relationship in the profits of the product as an inventor. The other authors have indicated they have no financial relationships relevant to this article to disclose.
Patient consent for publication Not required.
Ethics approval This trial was performed in accordance with the Declaration of Helsinki and the guidelines of Good Clinical Practice. The study was evaluated and approved by the ethics committees of Tuebingen University Hospital (094/2018BO1) and the Medical Association of Baden-Württemberg (B-F-2018–107). Both waived consent for observation and administration of surfactant due to the device’s CE mark and the urgent indication for LISA; parental written informed consent was subsequently obtained for data recording and analysis.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement All data relevant to the study are included in the article or uploaded as supplementary information.
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