Skin-to-skin care with the Skincubator for preterm infants
Official title: Skin-to-skin Care Using the Skincubator: Feasibility and Safety Trial
Run by The University of Texas Health Science Center, Houston · NCT07721662 · Data updated 2026-11-12
This study tests whether using the Skincubator during skin-to-skin care is safe and feasible for preterm babies and their parents in the NICU.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | Any age to 6 Days |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | The University of Texas Health Science Center, Houston Academic / other |
| Locations | 1 site (Houston, Texas) |
| Status | Recruiting |
| Started | July 13, 2026 |
| Main results expected | March 1, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | August 21, 2026 |
| Trial ID | NCT07721662 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are extremely preterm to preterm infants (24 0/7 to 30 6/7 weeks GA) who are clinically stable enough to participate and whose families and care teams are willing to engage in SSC using the Skincubator.
✕Probably not a fit
Infants with hemodynamic instability, significant oxygenation or ventilation needs, major congenital anomalies, or safety concerns identified by clinicians may not benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study assesses Skincubator-supported skin-to-skin care (SSC) in extremely preterm and preterm infants born at 24 weeks 0 days to 30 weeks 6 days gestation. It aims to measure changes in daily SSC duration, safety during NICU hospitalization, and feasibility and acceptability among parents and clinicians using an implementation framework. The study also evaluates thermal stability during Skincubator SSC and any effects on parental stress. Eligibility excludes infants with certain medical conditions or instability, and participation is contingent on physician safety judgment. The lead sponsor is The University of Texas Health Science Center, Houston.
Why it matters
Potential benefit: If successful, the Skincubator-supported SSC could increase bonding time and potentially improve infant stability and parental well-being.
How similar studies have gone: Previous approaches using incubator-assisted SSC have shown feasibility in neonates, but this specific Skincubator modality and its safety/feasibility in this population is being investigated.
Who can join: the full rules
Show full inclusion / exclusion criteria
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 it's running
-
The University of Texas Health Science Center at Houston
Houston, Texas, United States Recruiting
Study contacts
- Principal investigator: Jaclyn Ruggiero, MD — The University of Texas Health Science Center, Houston
- Study coordinator: Jaclyn E Ruggiero, MD
- Email: Jaclyn.E.Ruggiero@uth.tmc.edu
- Phone: (713) 500-5802
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.