Skin-to-skin Care Using the Skincubator: Feasibility and Safety Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 6
SponsorThe University of Texas Health Science Center, Houston
About this 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.
Eligibility criteria
Qualifiers
None
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Skincubator-supported SSC
- t-SSC
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov