Skin-to-skin Care Using the Skincubator: Feasibility and Safety Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Skin to Skin Care for Preterm Infants
• Intervention / Treatment: Device: Skincubator-supported SSC; Other: t-SSC

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jaclyn E Ruggiero, MD; Phone Number: (713) 500-5802; Email: Jaclyn.E.Ruggiero@uth.tmc.edu
• Study Contact Backup: Name: Matthew Rysavy; Phone Number: (713) 500-5651; Email: Matthew.A.Rysavy@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • The University of Texas Health Science Center at Houston
      • Contact: Matthew Rysavy; Phone Number: (713) 500-5651; Email: Matthew.A.Rysavy@uth.tmc.edu
      • Contact: Jaclyn E Ruggiero, MD; Phone Number: 713-500-5802; Email: Jaclyn.E.Ruggiero@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

-Extremely preterm (EP) and preterm (PT) infants born between 24 0/7 and 30 6/7 weeks' gestational age (GA)

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Skincubator-supported SSC	Device: 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
Active Comparator: Traditional SSC (t-SSC)	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average daily duration of SSC	this will be recorded as mean hours/day	First 7 days following randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety as assessed by the incidence of predefined adverse events(AEs)	AEs include; Respiratory tube or vascular access dislodgment; Skin breakdown, bruising, or compromise of skin integrity; Falls during SSC or during parent sleep; Moderate hypothermia or hyperthermia (as defined below) lasting more than 30 minutes; Apnea requiring bag-mask ventilation and escalation to cardiopulmonary resuscitation; Cardiorespiratory instability requiring escalation of support (e.g., new or increased mechanical ventilation); Hemodynamic deterioration requiring volume resuscitation or inotropes; Withholding of feeds due to suspected Necrotizing Enterocolitis (NEC); Severe complications such as Intraventricular Hemorrhage (IVH), NEC, or death	From randomization through NICU discharge (upto 100 days from randomization)
Safety as assessed by the number of infants that experience adverse events		From randomization through NICU discharge (upto 100 days from randomization)
Safety as assessed by the propotion of infants that experience adverse events		From randomization through NICU discharge (upto 100 days from randomization)
Feasibility of Skincubator-supported SSC as assessed by the Acceptability of Intervention Measure (AIM) among parents and clinical staff	This is a 4 item questionnaire and each is scored from 1(completely disagree)-5 (completely agree) for a total score range of 4-20. Higher scores indicate greater acceptability of the intervention.	end of intervention (7 days after randomization)
Acceptability as assessed by the Acceptability of Intervention Measure (AIM) among parents and clinical staff.	This is a 4 item questionnaire and each is scored from 1(completely disagree)-5 (completely agree) for a total score range of 4-20. Higher scores indicate greater acceptability of the intervention.	end of intervention (7 days after randomization)
Thermal Stability as assessed by the percentage of SSC session time		During SSC sessions in first 7 days post randomization
Change in parental stress as assessed by the Parental Stressor Scale:NICU (PSS:NICU) score	this is a 26 item questionnaire and each is scored on a 5-point likert scale from 1-5); higher scores indicate greater parental stress.	Baseline, days 5-7 post-randomization

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Jaclyn Ruggiero, MD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: July 18, 2026
• First Submitted That Met QC Criteria: July 18, 2026
• First Posted (Actual): July 23, 2026

Study Record Updates

• Last Update Posted (Actual): August 21, 2026
• Last Update Submitted That Met QC Criteria: August 19, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: skin to skin care; pre term infant; skincubator
• Other Study ID Numbers: HSC-MS-25-1097

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No