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NOT YET RECRUITING
NCT06543433
PHASE2/PHASE3

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

Sponsor: Itamar Nitzan

View on ClinicalTrials.gov

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 safety of skincubator. The main questions it aims to answer are: * Can the Skincubator keep a stable temperature for the smallest babies and the first days after birth? * How many hours will the parents (and other family members) will succeed to perform skin to skin every day? Participants will: Be offered the opportunity to perform Skincubator care for as long as they want to each day during the week after enrolment.

Official title: Skincubator (Model 2), a Novel Incubator for Skin to Skin Contact Feasibility Study, in Monash and Riverside

Key Details

Gender

All

Age Range

0 Days - 14 Days

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2024-08-31

Completion Date

2027-09-01

Last Updated

2024-08-09

Healthy Volunteers

No

Interventions

DEVICE

Skincubator 2

The Skincubator is a small incubator designed to attach to the caregiver's torso without any barrier between the parent's chest and the baby. It creates an environment with the advantages of a standard neonatal incubator, while enabling Skin to Skin contact for extended periods from birth. It has multiple access points, to allow for common nursing procedures. It is anchored safely to the parent's body and secures ventilator and IV tubing. It also includes side ports for the parents to insert their hands to touch their baby. The investigators will offer the parents in the intervention group the opportunity to perform Skincubator care for as long as they want to each day during the week after enrolment. The investigators will provide the parents with the aids to accomplish this goal: the Skincubator system with a convenient environment, the option for Skincubator surrogates and, where possible, the option for one of the parents to sleep with the baby safely secured in the Skincubator.

Locations (1)

Monash Children's hospital

Clayton, Victoria, Australia