Skin-to-skin Care Using the Skincubator: Feasibility and Safety Trial
Status: Recruiting
Location: See location...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Maximum Age: 6 days
Healthy Volunteers: f
View:
• Extremely preterm (EP) and preterm (PT) infants born between 24 0/7 and 30 6/7 weeks' gestational age (GA)
Locations
United States
Texas
The University of Texas Health Science Center at Houston
RECRUITING
Houston
Contact Information
Primary
Jaclyn E Ruggiero, MD
Jaclyn.E.Ruggiero@uth.tmc.edu
(713) 500-5802
Backup
Matthew Rysavy
Matthew.A.Rysavy@uth.tmc.edu
(713) 500-5651
Time Frame
Start Date: 2026-07-13
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 60
Treatments
Experimental: Skincubator-supported SSC
Active_comparator: Traditional SSC (t-SSC)
Related Therapeutic Areas
Sponsors
Leads: The University of Texas Health Science Center, Houston