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

Conditions

• Skin to Skin Care for Preterm Infants

Eligibility Criteria

Sex

ALL

Age

N/A - 6 Days

Healthy Volunteers

Not accepted

Interventions

• Skincubator-supported SSC — 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 — 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

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 Dates

First listed

Jul 23, 2026

Start date

Jul 13, 2026

Status verified

Aug 2026

Primary completion

Mar 1, 2027

Completion

Dec 31, 2027

Study Design

Enrollment

60 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Skincubator-supported SSC
• Active Comparator: Traditional SSC (t-SSC)

Primary Outcome Measure

Average daily duration of SSC [ Time Frame: First 7 days following randomization ]

Central Contacts

• Jaclyn E Ruggiero, MD
  (713) 500-5802
  [email protected]
• Matthew Rysavy
  (713) 500-5651
  [email protected]

Locations (1)

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