Home › NCT07721662

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

Who can join

6 Days · All sexes

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

About the study

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 is being tested

• Skincubator-supported SSC (device)
• t-SSC (other)

Sponsor: The University of Texas Health Science Center, Houston · Participants: 60 · Started: Jul 13, 2026

Contact the study team

• Jaclyn E Ruggiero, MD · Phone: (713) 500-5802
• Matthew Rysavy · Phone: (713) 500-5651

Official record on ClinicalTrials.gov — NCT07721662

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.