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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06543433




Registration number
NCT06543433
Ethics application status
Date submitted
3/08/2024
Date registered
9/08/2024

Titles & IDs
Public title
Skincubator, a Novel Incubator for Skin to Skin Contact Feasibility Study
Scientific title
Skincubator (Model 2), a Novel Incubator for Skin to Skin Contact Feasibility Study, in Monash and Riverside
Secondary ID [1] 0 0
V1 15.5.2024
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Preterm 0 0
Preterm Birth 0 0
Condition category
Condition code
Reproductive Health and Childbirth 0 0 0 0
Complications of newborn
Reproductive Health and Childbirth 0 0 0 0
Childbirth and postnatal care
Reproductive Health and Childbirth 0 0 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Skincubator 2

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


Treatment: Devices: 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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
hours of SSC per day
Timepoint [1] 0 0
In the first week from study commencement (study commencement will be defined as birth or receiving consent, whichever occurs later).
Primary outcome [2] 0 0
Parental Stress Scale (PSS) NICU
Timepoint [2] 0 0
4 to 7 days after birth.
Secondary outcome [1] 0 0
Time outside of temperature range 36.5-37.5
Timepoint [1] 0 0
In the first week from study commencement (study commencement will be defined as birth or receiving consent, whichever occurs later).
Secondary outcome [2] 0 0
time in environmental humidity of less than 60%
Timepoint [2] 0 0
In the first week from study commencement (study commencement will be defined as birth or receiving consent, whichever occurs later).

Eligibility
Key inclusion criteria
* Preterm neonates with birth weight of <1.5 kg
* Requiring respiratory support
* Cared for in an incubator with at least 60% humidity.
Minimum age
0 Days
Maximum age
14 Days
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
31/08/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2027
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Monash Children's hospital - Clayton
Recruitment postcode(s) [1] 0 0
3168 - Clayton

Funding & Sponsors
Primary sponsor type
Other
Name
Itamar Nitzan
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Monash University
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Monash Health
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Riverside University Health System Medical Center
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Itamar Nitzan, M.D
Address 0 0
Shaare Zedek Medical Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Itamar Nitzan, M.D
Address 0 0
Country 0 0
Phone 0 0
+972507414998
Fax 0 0
Email 0 0
itamarnitzan@gmail.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
The investigators will need to discuss with local IRBs


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06543433