The University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
Location status: Recruiting
Location contact
Jaclyn E Ruggiero, MD
CONTACT
Matthew Rysavy
CONTACT
Recruiting
NCT Number: NCT07721662
Skin-to-skin Care Using the Skincubator: Feasibility and Safety Trial
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
Up to 6 day
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Skincubator-supported SSC
DeviceParticipants 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
OtherInfants 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 outcomes
-
Average daily duration of SSC
Time frame: First 7 days following randomization
this will be recorded as mean hours/day
Secondary outcomes
-
Safety as assessed by the incidence of predefined adverse events(AEs)
Time frame: From randomization through NICU discharge (upto 100 days from randomization)
AEs include
- Respiratory tube or vascular access dislodgment
- Skin breakdown, bruising, or compromise of skin integrity
- Falls during SSC or during parent sleep
- Moderate hypothermia or hyperthermia (as defined below) lasting more than 30 minutes
- Apnea requiring bag-mask ventilation and escalation to cardiopulmonary resuscitation
- Cardiorespiratory instability requiring escalation of support (e.g., new or increased mechanical ventilation)
- Hemodynamic deterioration requiring volume resuscitation or inotropes
- Withholding of feeds due to suspected Necrotizing Enterocolitis (NEC)
- Severe complications such as Intraventricular Hemorrhage (IVH), NEC, or death
-
Safety as assessed by the number of infants that experience adverse events
Time frame: From randomization through NICU discharge (upto 100 days from randomization)
-
Safety as assessed by the propotion of infants that experience adverse events
Time frame: From randomization through NICU discharge (upto 100 days from randomization)
-
Feasibility of Skincubator-supported SSC as assessed by the Acceptability of Intervention Measure (AIM) among parents and clinical staff
Time frame: end of intervention (7 days after randomization)
This is a 4 item questionnaire and each is scored from 1(completely disagree)-5 (completely agree) for a total score range of 4-20. Higher scores indicate greater acceptability of the intervention.
-
Acceptability as assessed by the Acceptability of Intervention Measure (AIM) among parents and clinical staff.
Time frame: end of intervention (7 days after randomization)
This is a 4 item questionnaire and each is scored from 1(completely disagree)-5 (completely agree) for a total score range of 4-20. Higher scores indicate greater acceptability of the intervention.
-
Thermal Stability as assessed by the percentage of SSC session time
Time frame: During SSC sessions in first 7 days post randomization
-
Change in parental stress as assessed by the Parental Stressor Scale:NICU (PSS:NICU) score
Time frame: Baseline, days 5-7 post-randomization
this is a 26 item questionnaire and each is scored on a 5-point likert scale from 1-5); higher scores indicate greater parental stress.
Study contacts
Contact information is provided by the study sponsor or research team.
Jaclyn E Ruggiero, MD
CONTACT
Matthew Rysavy
CONTACT
Sponsors and collaborators
Lead sponsor
The University of Texas Health Science Center, Houston
Other
Registry information
Important dates
- Study start
- 2026
- Primary completion
- 2027
- Study completion
- 2027
- First posted
- Jul 23, 2026
- Registry last updated
- Aug 21, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.