Status:
NOT_YET_RECRUITING
Skincubator, a Novel Incubator for Skin to Skin Contact Feasibility Study
Lead Sponsor:
Itamar Nitzan
Collaborating Sponsors:
Monash University
Monash Health
Conditions:
Preterm
Preterm Birth
Eligibility:
All Genders
Up to 14 years
Phase:
PHASE2
PHASE3
Brief Summary
The goal of this clinical trial is to test the feasibility of using the Skincubator, a wearable incubator for skin to skin contact of preterm babies and their parents. It will also learn about the saf...
Detailed Description
Study design: This is a non-randomized feasibility trial with no control group in which the investigators will offer parents the option to perform Skincubator care - being cared for in SSC inside the ...
Eligibility Criteria
Inclusion
- Preterm neonates with birth weight of \<1.5 kg
- Requiring respiratory support
- Cared for in an incubator with at least 60% humidity.
Exclusion
- 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.
Key Trial Info
Start Date :
August 31 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06543433
Start Date
August 31 2024
End Date
September 1 2027
Last Update
August 9 2024
Active Locations (1)
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1
Monash Children's hospital
Clayton, Victoria, Australia, 3168