Skin to Skin Care for Preterm InfantsNCT07721662
Skin-to-skin Care Using the Skincubator: Feasibility and Safety Trial
A study testing Skincubator-supported SSC and t-SSC in people with Skin to Skin Care for Preterm Infants, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 6 days
- Conditions the study is for
- Skin to Skin Care for Preterm Infants
- What is being tested?
- Skincubator-supported SSC and t-SSC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jul 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 6 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- -Extremely preterm (EP) and preterm (PT) infants born between 24 0/7 and 30 6/7 weeks' gestational age (GA)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Jaclyn E Ruggiero, MD, 713-500-5802, Jaclyn.E.Ruggiero@uth.tmc.edu
Matthew Rysavy, (713) 500-5651, Matthew.A.Rysavy@uth.tmc.edu
About this 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.
- Conditions
- Skin to Skin Care for Preterm Infants
- Being tested
- Skincubator-supported SSC, t-SSC
- Keywords
- skin to skin care, pre term infant, skincubator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skincubator-supported SSCDevice
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-SSCOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Skincubator-supported SSC | Experimental | Not described Receives: Device: Skincubator-supported SSC |
| Traditional SSC (t-SSC) | Active comparator | Not described Receives: Other: t-SSC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average daily duration of SSC
this will be recorded as mean hours/day
Measured: First 7 days following randomization
Secondary outcomes (7)
Safety as assessed by the incidence of predefined adverse events(AEs)
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
Measured: From randomization through NICU discharge (upto 100 days from randomization)
Safety as assessed by the number of infants that experience adverse events
Measured: From randomization through NICU discharge (upto 100 days from randomization)
Safety as assessed by the propotion of infants that experience adverse events
Measured: 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
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.
Measured: end of intervention (7 days after randomization)
Acceptability as assessed by the Acceptability of Intervention Measure (AIM) among parents and clinical staff.
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.
Measured: end of intervention (7 days after randomization)
Thermal Stability as assessed by the percentage of SSC session time
Measured: During SSC sessions in first 7 days post randomization
Change in parental stress as assessed by the Parental Stressor Scale:NICU (PSS:NICU) score
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.
Measured: Baseline, days 5-7 post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start13 Jul 2026
- Primary completion1 Mar 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin to Skin Care for Preterm InfantsStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaclyn Ruggiero, The University of Texas Health Science Center, Houston
- Investigators
- Jaclyn Ruggiero, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07721662
- Sponsor's protocol ID
- HSC-MS-25-1097
- Status last verified
- Aug 2026
- First submitted
- 18 Jul 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skin-to-skin Care Using the Skincubator: Feasibility and Safety Trial
- ClinicalTrials.gov ID
- NCT07721662
- Acronym / sponsor ID
- HSC-MS-25-1097
- Conditions
- Skin to Skin Care for Preterm Infants
- Keywords
- skin to skin care, pre term infant, skincubator
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 13 Jul 2026 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 23 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Skincubator-supported SSC | Experimental | Device: Skincubator-supported SSC |
| Traditional SSC (t-SSC) | Active comparator | Other: t-SSC |
Who may qualify
- Ages
- Up to 6 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- -Extremely preterm (EP) and preterm (PT) infants born between 24 0/7 and 30 6/7 weeks' gestational age (GA)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skincubator-supported SSCParticipants 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 | Device | Skincubator-supported SSC |
| t-SSCInfants 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. | Other | Traditional SSC (t-SSC) |
Primary outcome
Average daily duration of SSC
Time frame: First 7 days following randomization
this will be recorded as mean hours/day
7 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)
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)
Acceptability as assessed by the Acceptability of Intervention Measure (AIM) among parents and clinical staff.
Time frame: end of intervention (7 days after randomization)
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: No
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Promoting Kangaroo Care for Preterm or Low Birthweight Infants in Rural India
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jaclyn Ruggiero, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skincubator-supported SSC and t-SSC in people with Skin to Skin Care for Preterm Infants, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jaclyn E Ruggiero, MD ((713) 500-5802, Jaclyn.E.Ruggiero@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average daily duration of SSC (time frame: First 7 days following randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.