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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Preterm Birth; Preterm
• Intervention / Treatment: Device: Skincubator 2

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 Skincubator, which is placed on the mother and/or another caregiver. Skincubator care will be provided from birth if the caring team and the parents feel it is appropriate. The option for Skincubator care will be provided for as long as the parents, surrogates, and staff feel comfortable with a goal of possible achievement of the WHO target of 8 hours per day. Each infant will participate in the study for one week from enrollment (If parents desire, they will be able to continue using the Skincubator beyond 1 week as long as NICU staff feel that it is helpful for the baby).

Implementation phase: Prior to beginning the study, each center will provide care in the Skincubator for five noninvasively ventilated preterm babies. After gaining experience in treating a preterm baby in the Skincubator and performing manikin simulations of Skincubator care for invasively ventilated babies, the NICU team in each center will be able to decide whether to include intubated babies in the trial.

Population: up to 25 preterm neonates in each site, born at GA of 24.0-32.6 with birth weight of <1.5 kg.

First 3 babies will be of GA of 26-32.6 and on noninvasive respiratory support. Those babies will be considered a learning phase for the team, and may be analyzed separately. After completing the learning phase the study will proceed with 4 groups:

1. Up to 7 more babies of GA of 26-32.6 and on noninvasive respiratory support.
2. 5 Intubated babies with GA of 26-32.6. The investigators will start enrolling babies from this group only after the team treated at least 5 babies from group 1 (including the learning phase) and feels ready to move on to intubated babies.
3. 5 babies GA 24.0-25.6 on noninvasive respiratory support. The investigators will start enrolling babies from this group only after the team treated at least 5 babies from group 1 (including the learning phase) and feels ready to move on to this age group.
4. 5 intubated babies with GA of 24.0-25.6. The investigators will start enrolling babies from this group only after the team treated at least 3 babies from group 2 and 3 babies from group 3, and only if the team feels ready to move on to this group also.

First five babies will be treated in the Skincubator only from NICU admission. After gaining experience with the first 5 babies the team may decide to start Skincubator care in birth suite (ideally on the mother, potentially on the father if the mother prefers or is feeling unwell) or in cesarean section theater (on the father).

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Itamar Nitzan, M.D; Phone Number: +972507414998; Email: itamarnitzan@gmail.com
• Study Contact Backup: Name: Alon Metrikin Gold; Email: alon@skincubator-neocare.com

Study Locations

• Australia
  • Victoria
    • Clayton, Victoria, Australia, 3168
      • Monash Children's Hospital
      • Contact: Calum Roberts, M.D; Phone Number: +61 3 8572 3657; Email: calum.roberts@monash.edu
      • Principal Investigator: Calum Roberts, M.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time outside of temperature range 36.5-37.5	Time outside of temperature range 36.5-37.5 measured axillary	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%	time in environmental humidity of less than 60% measured by hygrometer and incubator hygrometer	In the first week from study commencement (study commencement will be defined as birth or receiving consent, whichever occurs later).

Collaborators and Investigators

• Sponsor: Itamar Nitzan
• Collaborators: Monash University; Monash Health; Riverside University Health System Medical Center
• Investigators: Study Director: Itamar Nitzan, M.D, Shaare Zedek Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): August 31, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: August 3, 2024
• First Submitted That Met QC Criteria: August 6, 2024
• First Posted (Actual): August 9, 2024

Study Record Updates

• Last Update Posted (Actual): August 9, 2024
• Last Update Submitted That Met QC Criteria: August 6, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Premature Birth
• Other Study ID Numbers: V1 15.5.2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The investigators will need to discuss with local IRBs

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No