Clinical Trials and Testing
Skincubator's clinical evidence base now spans nearly 50 infants across prospective clinical studies, feasibility evaluations, and structured nurse simulations — with three peer-reviewed publications covering thermoregulation, device performance, parental experience, and clinical safety and usability.
Early Clinical Experience
Beyond the published studies, the Skincubator has supported prolonged SSC in extremely preterm and invasively ventilated infants born before 28 weeks' gestation. Prolonged sessions have been achieved safely, with some families reaching the WHO-recommended target of 8 or more hours of SSC in a single day, and preliminary data showing SSC session length can be doubled in this population. Across device use to date, no moderate hypothermia, line dislodgement, or desaturation requiring session termination has been observed.
Safety Study
A prospective clinical study at Shaare Zedek Medical Center (Level IV NICU) compared Skincubator-supported SSC with traditional SSC in preterm infants (24–33 weeks gestational age). Skincubator-supported SSC maintained superior thermal stability — a mean temperature drop of ~0.2 °C versus ~0.4 °C during traditional SSC — with no episodes of moderate hypothermia during device use. Humidity averaged 85 ± 7% and stayed above 70% for 93% of the session time.
Nitzan I, Kasirer Y, Mimouni FB, et al. American Journal of Perinatology. 2025;42(13):1721–1728.
Published · DOI: https://doi.org/10.1055/a-2526-5064 · Trial registration: MOH_2021-12-13_010470
2 — Device performance and parental experience (Skincubator 2.0)
A clinical study of the Skincubator 2.0 in preterm infants, including infants with umbilical lines, assessed device performance and parental perception. Parents reported that the device felt safer and more comfortable than traditional SSC and enabled them to rest and even sleep while their infant remained securely supported — supporting longer, more frequent sessions (up to 4.2 hours per session and nearly 9 hours per day).
Nitzan I, Phillips R, Morag I, et al. Device Performance and Parental Perception of the Skincubator 2.0, a Wearable Device to Support Prolonged Skin-to-Skin Care for Preterm Infants. American Journal of Perinatology. 2026.
Published online ahead of print · DOI: https://doi.org/10.1055/a-2834-0694 · Trial registration: MOH_2025-08-10_014235
3 — Nurse-perceived safety and convenience (manikin simulation, Monash)
At Monash Children's Hospital (Melbourne, Australia), 20 experienced NICU nurses evaluated Skincubator-assisted transfers and procedures using a manikin configured as a 29-week infant on CPAP or a 25-week intubated infant with umbilical lines. Nurses rated the safety of the Skincubator transfer system a median of 5 out of 5, versus 3 for traditional SSC transfer (p = 0.003), and reported reduced infant handling and greater convenience.
Yeomans E, Paton S, Kuipers E, et al. Journal of Neonatal Nursing. 2025;31(5):101714.
Published · DOI: https://doi.org/10.1016/j.jnn.2025.101714