Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000441415
Ethics application status
Approved
Date submitted
12/02/2025
Date registered
12/05/2025
Date last updated
12/05/2025
Date data sharing statement initially provided
12/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Silicone gel for skin protection in the most vulnerable newborns
Scientific title
Safety and feasibility of a film-forming silicone gel for skin protection in the most vulnerable newborns – A pilot randomised controlled trial
Secondary ID [1] 313554 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Premature birth 336044 0
Skin infection 336045 0
Condition category
Condition code
Infection 333381 333381 0 0
Other infectious diseases
Skin 332609 332609 0 0
Other skin conditions
Reproductive Health and Childbirth 332610 332610 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This trial will compare the current standard extremely preterm skin care in our NICU, to the investigational product, StrataCTX. StrataCTX is included in the Australian Register of Therapeutic Goods (#317640) as a skin semi-occlusive dressing for the treatment of dry skin and cutaneous rashes, and is suitable for children, including infants, and people with sensitive skin.
Assessment: Infants in the trial will be monitored daily for 14 days post birth. Skin condition will be assessed daily using standardized neonatal skin condition scores (NSCS) (performed each shift as part of routine care for every NICU patient), with additional photographic documentation.
Skin microbiome: Superficial skin swabs will be collected from the neck, chest and abdomen on days 1 (prior to start of intervention), 8-10 (following completion of 7 days intervention) and 14-16 (wash-out period).
Intervention: StrataCTX, a silicon polymer-based gel, produced by Swiss skin care specialist Stratpharma which dries into a thin, transparent, protective layer that bonds lightly to the skin and provides an optimised environment for healing and re-epithelisation.
The intervention will be applied by a trained research nurse dedicated to the project.
The StrataCTX is applied to the neck and frontal torso of the infant 2-4 times daily, starting within 24h from birth, for the first 7 days of life (time of highest risk of skin injuries to torso). A minimum amount of StrataCTX to create a thin film that dries within ~5 min (required volume ca. 1-1.5 ml) will be applied. Other body areas will receive routine treatment with topical coconut oil. For infants < 25 weeks GA, the gel is applied withn 24 hours of birth, 4 x daily. For infants >= 25 weeks GA, the gel is applied twice daily.
The application of gel is recorded every day (4 times, 3 times, 2 times, 1 time, not applied. The reason is noted if application is once or less).
Daily photographs are taken of skin condition and daily NSCS recorded for 14 days post admission.
Intervention code [1] 330145 0
Prevention
Intervention code [2] 330691 0
Treatment: Other
Comparator / control treatment
Infants randomised to the control group will receive topical coconut oil to the entire skin, including the neck and frontal torso, 2-4 times daily as per current guidelines (CAHS Guideline - Skin Care Guideline 28 May 2024, Neonatal Coconut oil 29 Jan 2024))
This comparator is the current standard for extremely preterm skin care in our Department. For infants < 25 weeks GA, topical coconut oil is applied within 24 hours of birth, 4 x daily. For infants >= 25 weeks GA, topical coconut oil is applied twice daily within 24 hours of birth.
The coconut oil is applied by the clinical nursing staff. The application of coconut oil to the study infants will be recorded daily as part of study data collection and recorded every day from birth (4 times, 3 times, 2 times, 1 time, not applied. The reason is noted if application is once or less).
Control group
Active

Outcomes
Primary outcome [1] 340125 0
Feasibility
Timepoint [1] 340125 0
Treatment is within 24 hours of birth (Day 1). Timepoints for data collection is daily for 16 days post birth.
Primary outcome [2] 340124 0
Safety
Timepoint [2] 340124 0
Treatment is within 24 hours of birth (Day 1). Timepoints for data collection is daily for 16 days post birth.
Primary outcome [3] 340126 0
Neonatal Skin Condition Score
Timepoint [3] 340126 0
Treatment is within 24 hours of birth (Day 1). Timepoints for collection of NSCS is daily for 16 days post birth.
Secondary outcome [1] 442853 0
Skin integrity, (surface topography)
Timepoint [1] 442853 0
Days 1, (prior to treatment) on day3 or 4 (during treatment) and day 8 or 9 or 10 (post treatment).
Secondary outcome [2] 442854 0
Non-invasive determination of skin hydration
Timepoint [2] 442854 0
Days 1, (prior to treatment) on day3 or 4 (during treatment) and day 8 or 9 or 10 (post treatment).
Secondary outcome [3] 442852 0
Comparative skin microbiome analysis
Timepoint [3] 442852 0
Skin swabs will be taken on day 1 (prior to first application of StrataCTX gel, or first application of coconut oil, on day 8 or 9 or 10 (post treatment) and on day 14,15, or 16 (wash out period).

Eligibility
Key inclusion criteria
a) Infants born at less than 26 weeks gestational age and within 24h from birth.
b) Parental written consent obtained.
Minimum age
No limit
Maximum age
26 Weeks
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a) Infants with congenital skin disorders or surgical conditions contraindicating topical treatment.
b) Infants whose parents do not provide consent.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment. Computer generated randomisation will be performed via the WA Health REDCap.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomisation will be performed via the WA Health REDCap.; Permuted block randomisation; Multiples will be allocated to the same treatment arm
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
As this is a pilot trial, most of the statistics will be descriptive. Analysis will be based on the intention-to-treat principle. Continuous data will be summarised using medians and inter-quartile ranges (IQR), and categorical data will be summarised using frequency distributions. Univariate group comparisons will be performed using the X2 and Fisher exact tests, as appropriate. Linear regression analysis on log-transformed repeated NSCS scores over a period of 7 days will be performed with individual neonates modelled as random effects. The interaction between group and time will be modelled to evaluate changes in NSCS scores over time. The pairwise comparisons between the groups and pairwise contrasts within each group at each time point will be tested at an overall significance level 0.05 with Bonferroni correction for multiple comparisons. Data analyses will be performed using SPSS version 29 (IBM, Armonk, New York, NY, USA). All hypothesis tests will be 2-sided, and p values <0.05 will be considered significant.
Sample size: This pilot trial will assess the primary outcomes of feasibility and safety and initial assessment of efficacy. Based on limited published data on the incidence of skin injuries in extremely preterm infants, recruitment of 40 infants (20 each in intervention and control arm) assures 80% power to detect a 1 standard deviation difference in the skin integrity score in the intervention versus control arm infants in this pilot RCT. All hypothesis tests will be 2-sided, and p values <0.05 will be considered significant.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
13/05/2025
Actual
Date of last participant enrolment
Anticipated
30/04/2026
Actual
Date of last data collection
Anticipated
14/05/2026
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 27404 0
King Edward Memorial Hospital - Subiaco
Recruitment postcode(s) [1] 43517 0
6008 - Subiaco

Funding & Sponsors
Funding source category [1] 318017 0
Commercial sector/Industry
Name [1] 318017 0
Stratpharma
Country [1] 318017 0
Switzerland
Primary sponsor type
Government body
Name
Child and Adolescent Health Service (WA)
Address
Country
Australia
Secondary sponsor category [1] 320360 0
None
Name [1] 320360 0
Address [1] 320360 0
Country [1] 320360 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316676 0
Child and Adolescent Health Service Human Research Ethics Committee
Ethics committee address [1] 316676 0
Ethics committee country [1] 316676 0
Australia
Date submitted for ethics approval [1] 316676 0
16/09/2024
Approval date [1] 316676 0
11/12/2024
Ethics approval number [1] 316676 0

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

Contacts
Principal investigator
Name 138626 0
Prof Tobias Strunk
Address 138626 0
Neonatal Directorate, King Edward Memorial Hospital, 374 Bagot Rd, Subiaco, WA 6008
Country 138626 0
Australia
Phone 138626 0
+61 8 64582099
Fax 138626 0
Email 138626 0
[email protected]
Contact person for public queries
Name 138627 0
Tobias Strunk
Address 138627 0
Neonatal Directorate, King Edward Memorial Hospital, 374 Bagot Rd, Subiaco, WA 6008
Country 138627 0
Australia
Phone 138627 0
+61 8 64582099
Fax 138627 0
Email 138627 0
[email protected]
Contact person for scientific queries
Name 138628 0
Tobias Strunk
Address 138628 0
Neonatal Directorate, King Edward Memorial Hospital, 374 Bagot Rd, Subiaco, WA 6008
Country 138628 0
Australia
Phone 138628 0
+61 8 64561260
Fax 138628 0
Email 138628 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.