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Observational Study
. 2021 Mar;106(2):211-214.
doi: 10.1136/archdischild-2020-319792. Epub 2020 Oct 6.

Clinical evaluation of an application aid for less-invasive surfactant administration (LISA)

Christian Achim Maiwald  1   2 , Patrick Neuberger  3 , Axel R Franz  4   2 , Corinna Engel  2 , Matthias Vochem  3 , Christian F Poets  4 ; Neofact – feasibility Study Group; Neofact® – feasibility Study Group
Collaborators, Affiliations
Observational Study

Clinical evaluation of an application aid for less-invasive surfactant administration (LISA)

Christian Achim Maiwald et al. Arch Dis Child Fetal Neonatal Ed. 2021 Mar.

Abstract

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.

Keywords: neonatology; resuscitation; technology.

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Conflict of interest statement

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.

Figures

Figure 1
Figure 1
Surfactant application device (Neofact®).
Figure 2
Figure 2
Patient flow.
See this image and copyright information in PMC

References

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