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International Journal of Bioprinting Customized 3D nasal masks for ELBW infants

It is classified as a medical resin, and its applications trial (PI21/00628) that will be carried out later, these data
include the production of medical models and devices. will be recorded.
The mask manufactured with this resin can be sterilized The customized nasal mask fabricated by 3D printing
by superheated steam (autoclave sterilization) without in this study is a highly personalized mask for extremely
altering its mechanical properties, as indicated by the small, premature newborns, and it offers better seal that
manufacturer. To date, no studies have been carried allows for better transmission of pressure, thereby reducing
out to prototype customized nasal mask using Elastic the need for supplemental oxygen. In contrast, TM does
50 resin. Thus, a short-duration test of 2 hours was not usually fit well to the premature nasal region; therefore,
required for close follow-up. In this pilot study, the M3D it is generally less effective in NIV.
made a correct seal and improved the parameters of NIV
but left behind mild perinasal red marks on the surface of The first prototype as reported in this study produced
the nasal root, which, fortunately, did not result in a skin some marks in the nasal root of the infant; however, we
lesion or allergic reaction. anticipate improvement in this regard when new materials
are to be utilized in the clinical trial, which is currently
In this first prototype, no cushion was added to the
nasal mask. Although the wall is thin, the cushion, which is underway.
custom-made, fits well to the nasal surface of the premature
infant, and it is not necessary to fix the M3D in the same 5. Conclusion
way as with the TM. A clinical trial has been launched to evaluate the safety and
It would be desirable for this resin to have a Shore A efficacy of the customized nasal masks in ELBW infants.
18 to 20 hardness so that it has the properties of a silicone 3D printing opens up a new field for fabricating items for
(i.e., softer and more flexible), which could help prevent ELBW children.
the marking on the nasal cutaneous area of the premature
infant while maintaining the correct transmission. Acknowledgments
In this initial phase of the application of M3D, we The authors thank the infant’s parents for their collaboration
observed that there was presumably better pressure and participation.
transmission since the nasal seal was much better given
that the mask was custom-made. Therefore, it was possible Funding
to reduce the oxygen supply required through NIV in the This study was funded by Instituto de Salud Carlos III
2 hours when the infant subject was being tested. (ISCIII) “PI21/00628” and co-funded by the European
Adjustments to the NIV, such as a decrease in Union.
supplemental oxygen concentration according to the
infant’s oxygen saturation, were necessary because the M3D Conflict of interest
had a better seal. Figure 4 shows the oxygen requirements All authors declare no conflicts of interests.
both in the incubator and in the kangaroo position.
The only side effect was the transient mark described Author contributions
in the nasal root. Since the mask was put on for only Conceptualization: María Teresa Moral-Pumarega, Carmen
2 hours, observations and outcomes for longer duration Rosa Pallás-Alonso, Antonio Martín-González
are required for further validation. We will also need Investigation: María Teresa Moral-Pumarega, Antonio
to identify the most suitable resin for fabrication. All Martín-González, Begoña Morrás de la Torre, Aaron
newborns under 1,500 g should be routinely followed up Jesús Pérez-López, Alejandro Ferrando-Sánchez,
after hospital discharge. Elena Bergon-Sendin
When M3D was replaced by TM, more supplemental Formal analysis: María Teresa Moral-Pumarega, Antonio
oxygen was needed. One of the limitations of this study Martín-González, Begoña Morrás -de la Torre,
is that the data revolving around the supplemental Alejandro Ferrando-Sánchez, Aaron Jesús Pérez-López
oxygen upon the mask replacement were not recorded Writing – original draft: María Teresa Moral-Pumarega,
but were directly observed by the investigators. The Antonio Martín-González, Begoña Morrás de la Torre
parents requested that the application of M3D should be Writing – review & editing: María Teresa Moral-Pumarega,
continued, but such request was not accommodated since Antonio Martín- Gónzález, Begoña Morrás de la Torre,
this was the pilot phase of the study. Another limitation is Elena Bergon-Sendin, Alejandro Ferrando-Sánchez,
that the M3D was tested on only one infant. In the clinical Aaron Jesús Pérez-López, Carmen Rosa Pallás-Alonso

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Volume 9 Issue 1 (2023)olume 9 Issue 1 (2023) 75 https://doi.org/10.18063/ijb.v9i1.627