Recruiting

Skincubator

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT07721662

Conditions

Skin to Skin Care for Preterm Infants

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

Skincubator-supported SSC

t-SSC

Study Details

Brief 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.

Conditions

Skin to Skin Care for Preterm Infants

Study ID

NCT07721662

Start date

Jul 13, 2026

Status verified date

Aug, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Mar 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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 Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Skincubator-supported SSC

active comparator: Traditional SSC (t-SSC)

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Jaclyn E Ruggiero, MD

(713) 500-5802Jaclyn.E.Ruggiero@uth.tmc.edu

Matthew Rysavy

(713) 500-5651Matthew.A.Rysavy@uth.tmc.edu

Locations

The University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Jaclyn E Ruggiero, MD

713-500-5802Jaclyn.E.Ruggiero@uth.tmc.edu

Matthew Rysavy

(713) 500-5651Matthew.A.Rysavy@uth.tmc.edu

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

Aug 21, 2026

Last verified

Aug, 2026

Keywords

  • skin to skin care
  • pre term infant
  • skincubator

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2026-08-21.