PretermPhase 2/3NCT06543433
Skincubator, a Novel Incubator for Skin to Skin Contact Feasibility Study
A Phase 2/3 study testing Skincubator 2 in people with Preterm and Preterm Birth, run by Itamar Nitzan at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 14 days
- Conditions the study is for
- Preterm, Preterm Birth
- What is being tested?
- Skincubator 2
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteAustralia
- Study dates
- 31 Aug 2024to 1 Sep 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 14 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm neonates with birth weight of <1.5 kg
- Requiring respiratory support
- Cared for in an incubator with at least 60% humidity.
Who cannot join
- Critical congenital heart disease
- Suspected genetic syndrome
- Hemodynamic instability
- Having a chest tube,
- Significant congenital anomalies,
- Need for surgery
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Alon Metrikin Gold contact
Australia1 site
Monash Children's hospital
Clayton, Victoria, 3168
Calum Roberts, M.D, +61 3 8572 3657, calum.roberts@monash.edu
Calum Roberts, M.D
About this study
Official title: 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.
Read the 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:
- Up to 7 more babies of GA of 26-32.6 and on noninvasive respiratory support.
- 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.
- 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.
- 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).
- Conditions
- Preterm, Preterm Birth
- Being tested
- Skincubator 2
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skincubator 2Device
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 group | Role | What they receive |
|---|---|---|
| Skincubator | Experimental | This is the only arm. All babies in trial will receive the intervention. Receives: Device: Skincubator 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
hours of SSC per day
primary neonatal outcome will be hours of SSC per day
Measured: 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.
Measured: 4 to 7 days after birth.
Secondary outcomes (2)
Time outside of temperature range 36.5-37.5
Time outside of temperature range 36.5-37.5 measured axillary
Measured: 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
Measured: In the first week from study commencement (study commencement will be defined as birth or receiving consent, whichever occurs later).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start31 Aug 2024 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PretermStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The intervention will be given to all participants and the investigators will test how many hours of SSC per day the parents can achieve.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Itamar Nitzan
- Sponsor type
- University, hospital or other
- Collaborators
- Monash University, Monash Health, Riverside University Health System Medical Center
- Responsible party
- Sponsor-investigator, Itamar Nitzan, Shaare Zedek Medical Center
- Investigators
- Itamar Nitzan, M.D, Study director, Shaare Zedek Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06543433
- Sponsor's protocol ID
- V1 15.5.2024
- Status last verified
- Aug 2024
- First submitted
- 3 Aug 2024
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The investigators will need to discuss with local IRBs
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skincubator (Model 2), a Novel Incubator for Skin to Skin Contact Feasibility Study, in Monash and Riverside
- ClinicalTrials.gov ID
- NCT06543433
- Acronym / sponsor ID
- V1 15.5.2024
- Conditions
- Preterm, Preterm Birth
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Itamar NitzanUniversity, hospital or other
- Collaborators
- Monash University, Monash Health, Riverside University Health System Medical Center
- Study start
- 31 Aug 2024 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- Up to 7 more babies of GA of 26-32.6 and on noninvasive respiratory support.
- 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.
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The intervention will be given to all participants and the investigators will test how many hours of SSC per day the parents can achieve.
| Arm | Type | Receives |
|---|---|---|
| Skincubator | Experimental | Device: Skincubator 2This is the only arm. All babies in trial will receive the intervention. |
Who may qualify
- Ages
- 0 to 14 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Preterm neonates with birth weight of <1.5 kg
- Requiring respiratory support
- Cared for in an incubator with at least 60% humidity.
Key exclusion criteria (9 listed)
- Critical congenital heart disease
- Suspected genetic syndrome
- Hemodynamic instability
- Having a chest tube,
- Significant congenital anomalies,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skincubator 2The 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. | Device | Skincubator |
Primary outcome
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).
primary neonatal outcome will be hours of SSC per day
Parental Stress Scale (PSS) NICU
Time frame: 4 to 7 days after birth.
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.
2 secondary outcomes
Time outside of temperature range 36.5-37.5
Time frame: 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 frame: In the first week from study commencement (study commencement will be defined as birth or receiving consent, whichever occurs later).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Individual participant dataSharing planned: Undecided. The investigators will need to discuss with local IRBs
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alon Metrikin Gold contact
Itamar Nitzan, M.D study director
Shaare Zedek Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Skincubator 2 in people with Preterm and Preterm Birth, run by Itamar Nitzan at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Itamar Nitzan, M.D (+972507414998, itamarnitzan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.