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Skin-to-skin Care Using the Skincubator: Feasibility and Safety Trial

RecruitingNAAges any - 6 DaysAllThe University of Texas Health Science Center, Ho…
NCT07721662 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Skincubator-supported SSC
  • t-SSC
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Where

1 site
The University of Texas Health Science Center at Houston
Houston, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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