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Accepting PatientsObservationalNCT07721662

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

Skin to Skin Care for Preterm Infants

Phase:Observational
Status:Accepting Patients
Age:Up to 6 Days
Gender:All
Locations:1 site

What This Study Is About

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.

Who Can Participate

You May Qualify If
  • Extremely preterm (EP) and preterm (PT) infants born between 24 0/7 and 30 6/7 weeks' gestational age (GA)
You Cannot Join If
  • 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
  • +2 more...
View Full Eligibility Criteria
Full Criteria (from ClinicalTrials.gov)

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

Important: This is a summary. The final determination of eligibility will be made by the trial coordinator after reviewing your complete medical history.

Study Locations

The University of Texas Health Science Center at Houston — Houston, Texas

Contact

Contact

Jaclyn E Ruggiero, MD

Experimental Treatment

This trial is testing a new treatment. Results are not guaranteed. Talk to your doctor before applying.

Apply to This Trial

Your information will be sent to the study coordinator for review.