NCT07721662NARecruiting
Skin-to-skin Care Using the Skincubator: Feasibility and Safety Trial
The University of Texas Health Science Center, Houston
Start Date
7/13/2026
Completion Date
12/31/2027
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.
Eligibility Criteria
Age Range: No minimum to No maximum
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
Interventions
DEVICE
Skincubator-supported SSC
OTHER
t-SSC
Conditions
Skin to Skin Care for Preterm Infants
Locations
The University of Texas Health Science Center at Houston
Houston, Texas 77030
United States