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

NCT06543433 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-08-09

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Monash University

    collaborator OTHER

  • Monash Health

    collaborator OTHER

  • Riverside University Health System Medical Center

    collaborator OTHER

  • Itamar Nitzan

    lead OTHER

Principal Investigators

  • Itamar Nitzan, M.D · Shaare Zedek Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
0 Days
Max Age
14 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-31
Primary Completion
2026-09-01
Completion
2027-09-01

Countries

  • Australia

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06543433 on ClinicalTrials.gov