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

Sponsor
Itamar Nitzan
Study ID
NCT06543433
Phase
PHASE2/PHASE3
Status
Not Yet Recruiting

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Conditions

  • Preterm
  • Preterm Birth

Eligibility Criteria

Sex
ALL
Age
0 Days - 14 Days
Healthy Volunteers
Not accepted

Interventions

  • Skincubator 2 — DEVICE
    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.

Study Details

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.

Key Dates

First listed
Aug 9, 2024
Start date
Aug 31, 2024
Status verified
Aug 2024
Primary completion
Sep 1, 2026
Completion
Sep 1, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Skincubator
    This is the only arm. All babies in trial will receive the intervention.

Primary Outcome Measure

hours of SSC per day [ Time Frame: In the first week from study commencement (study commencement will be defined as birth or receiving consent, whichever occurs later). ]

Central Contacts

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