Skincubator, a Novel Incubator for Skin to Skin Contact Feasibility Study

Launched by ITAMAR NITZAN · Aug 6, 2024

Keywords

ClinConnect Summary

This clinical trial, called the Skincubator study, is designed to explore a new wearable incubator that supports skin-to-skin contact between preterm babies and their parents. The main goal is to see if the Skincubator can maintain a stable temperature for tiny babies in their first days of life and to find out how many hours parents and family members can safely hold their baby skin-to-skin each day. This type of contact is important because it can help with bonding and improve the baby’s health.

To participate in this trial, babies must be preterm, weigh less than 1.5 kg, and need help with breathing. However, some babies are not eligible, especially those with serious heart problems or other health issues. If you join the study, you’ll have the chance to use the Skincubator for as long as you want each day during the week after you enroll. It’s important to know that the trial is not yet recruiting participants, but it aims to help improve care for preterm babies through this innovative approach.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Preterm neonates with birth weight of \<1.5 kg
• • Requiring respiratory support
• • Cared for in an incubator with at least 60% humidity.
• Exclusion Criteria:
• • Critical congenital heart disease
• • Suspected genetic syndrome
• • Hemodynamic instability
• • Having a chest tube,
• • Significant congenital anomalies,
• • Need for surgery
• • If the attending neonatologist decides that the Skincubator is not safe for a specific baby.
• • Neonates whose mothers have a significant mental disorder that is not adequately controlled
• • Neonates of parents unable to perform extended SSC for any reason will be excluded as well.