NCT07721662 · The University of Texas Health Science Center, Houston
Skin-to-skin Care Using the Skincubator: Feasibility and Safety Trial
What this study is about
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.
View original scientific description
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.
Interventions
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
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.
Primary outcome measures
Average daily duration of SSC
Time frame: First 7 days following randomization
this will be recorded as mean hours/day
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Houston, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 21, 2026 · Source of record for eligibility and locations