What this study is
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.
What's being tested
- Skincubator-supported SSC
Intervention · DEVICE
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
Intervention · OTHER
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.
Study details
- Sponsor
- The University of Texas Health Science Center, Houston
- Conditions
- Skin to Skin Care for Preterm Infants
- Enrolling
- 60 people
- Starts
- 2026-07-13
- Est. completion
- 2027-12-31
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age Up to 6 DaysSex ALLHealthy volunteers Not acceptedYou may qualify if
- Extremely preterm (EP) and preterm (PT) infants born between 24 0/7 and 30 6/7 weeks' gestational age (GA)
You can't join if
- Birth weight > 2kg.
- Hemodynamic instability, defined as new or escalating inotropic support within 12 hours prior to randomization
- Chest tube in place at time of enrollment.
- Oxygenation failure, defined as persistent preductal oxygen saturation < 85% despite 100% fraction of inspired oxygen (FiO2).
- Recurrent apnea, requiring bag-mask ventilation more than twice within the 12 hours prior to randomization
- Known or suspected congenital anomalies or genetic conditions, including Trisomy 13, 18, 21 or cystic fibrosis Multiple gestation, including twins or higher-order multiples
- Determination by the attending neonatologist that participation is not safe for a given infant
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openThe University of Texas Health Science Center at Houston
Houston, Texas, United States
- Jaclyn E Ruggiero, MD · Contact713-500-5802Jaclyn.E.Ruggiero@uth.tmc.edu
- Matthew Rysavy · Contact(713) 500-5651Matthew.A.Rysavy@uth.tmc.edu
Recruiting
Study team
Sponsor
The University of Texas Health Science Center, Houston
Study ID HSC-MS-25-1097
Principal investigator
Jaclyn Ruggiero, MD
The University of Texas Health Science Center, Houston
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.