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

NCT06543433 | Not Yet Recruiting Phase 2

• 1 other identifier: V1 15.5.2024
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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 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

Preterm; Preterm Birth

Outcome Measures

Primary Outcomes (2)

• hours of SSC per day

  primary neonatal outcome will be hours of SSC per day

  In the first week from study commencement (study commencement will be defined as birth or receiving consent, whichever occurs later).

• Parental Stress Scale (PSS) NICU

  Parental Stress Scale (PSS) NICU performed by the mother. Minimum and maximum values for PSS NICU are 0 and 72, higher scoring indicates higher parental stress.

  4 to 7 days after birth.

Secondary Outcomes (2)

• Time outside of temperature range 36.5-37.5

  In the first week from study commencement (study commencement will be defined as birth or receiving consent, whichever occurs later).

• time in environmental humidity of less than 60%

  In the first week from study commencement (study commencement will be defined as birth or receiving consent, whichever occurs later).

Study Arms (1)

Skincubator

EXPERIMENTAL

This is the only arm. All babies in trial will receive the intervention.

Device: Skincubator 2

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.

Skincubator

Eligibility Criteria

• Age: 0 Days - 14 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Preterm neonates with birth weight of \<1.5 kg
• Requiring respiratory support
• Cared for in an incubator with at least 60% humidity.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Itamar Nitzan: lead
• Monash University: collaborator
• Monash Health: collaborator
• Riverside University Health System Medical Center: collaborator

Study Sites (1)

Monash Children's hospital

Clayton, Victoria, 3168, Australia

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Itamar Nitzan, M.D

  Shaare Zedek Medical Center

  STUDY DIRECTOR

Central Study Contacts

Itamar Nitzan, M.D

CONTACT

+972507414998; itamarnitzan@gmail.com

Alon Metrikin Gold

CONTACT

alon@skincubator-neocare.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr

Model Details: The intervention will be given to all participants and the investigators will test how many hours of SSC per day the parents can achieve.

Study Record Dates

• First Submitted: August 3, 2024
• First Posted: August 9, 2024
• Study Start: August 31, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: August 9, 2024

Record last verified: 2024-08

Locations

AU (1)