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Skin-to-skin Care Using the Skincubator: Feasibility and Safety Trial
Sponsor: The University of Texas Health Science Center, Houston
Summary
The purpose of this study is to assess the impact of the Skincubator on average daily duration of Skin-to-skin Care (SSC), to assess the safety of Skincubator-supported SSC during NICU hospitalization, to evaluate feasibility and acceptability of the Skincubator among parents and clinical staff using the Acceptability of Intervention Measure (AIM) implementation framework to assess thermal stability during Skincubator-supported SSC and to assess changes in parental stress associated with Skincubator use during NICU hospitalization.
Key Details
Gender
All
Age Range
Any - 6 Days
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2026-07-13
Completion Date
2027-12-31
Last Updated
2026-08-21
Healthy Volunteers
No
Conditions
Interventions
Skincubator-supported SSC
Participants will receive SSC using the Skincubator, a novel wearable neonatal device designed to support a warm, humidified environment during SSC sessions. The device includes a retractable transfer pad, a secure line management nest, and a transparent top cover with multiple access points for routine care
t-SSC
Infants in the control group will receive routine care, including t-SSC per NICU protocol without the use of a supportive device. Parents will be encouraged to engage in SSC as frequently and for as long as possible. To ensure equitable support, control group families will receive the same educational materials, planning tools, and comfort measures as those in the intervention group. SSC will be facilitated using typical swaddling techniques without the use of the Skincubator.
Locations (1)
The University of Texas Health Science Center at Houston
Houston, Texas, United States