A Longitudinal Investigation of Skin Barrier Development From Birth and the Validation of Early Predictors of Atopic Eczema Risk: the Skin Testing for Atopic Eczema Risk (STAR) Study (STAR)

April 14, 2023 updated by: Sheffield Teaching Hospitals NHS Foundation Trust

Eczema is a chronic disease of the skin that is becoming more common worldwide for reasons unknown. Currently the best indicator that a baby will suffer from eczema is if either or both parents have the condition, although this is not always the case. The goal of this study is to find out if, from birth, the skin of babies who later go on to suffer from eczema develops differently to those who do not. By doing this the research team hope to detect early signs of the disease within the first year of life. Our researchers will ask 150 families from the local Sheffield community to take part in a 1-year study.

To monitor baby skin development, the investigators will carry out 3 simple procedures at the skin surface that pose no risk to the baby. These procedures will be performed on the arm and thigh, at birth, 4 weeks, and 12 months of age. In addition the investigators will ask parents to answer questionnaires and fill out diaries at specific time points throughout the year, to collect information on how they care for their baby's skin. By recording which babies go on to, and do not, develop eczema the investigators hope to: (1) better understand baby skin development from birth, (2) identify if these simple procedures can predict the development of eczema during the first 12 months of life, and (3) investigate environmental effects that may cause disease onset. In a medical era where the prevention of eczema is the long-term goal, it is hoped that this study will provide a new way to identify babies that may go on to develop eczema. This will allow healthcare professionals to offer specific skin care advice from birth, and empower parents to take measured action to help prevent the emergence of eczema in their baby.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The primary aim of this study is to investigate the relationship between skin barrier structure/function and skin health in a longitudinal birth cohort. The study (including the purpose and design) has been externally reviewed by a group of peers and was awarded funding by the Leo Foundation.

There is no therapeutic intervention and we will offer no healthcare advice. All participants will be instructed to seek medical care as needed from their normal service provider. As such there are no significant ethical implications.

This study involves a series of harmless procedures to test the properties of the skin in babies and the collection of information on how parents care for their baby's skin over the first 12 months of life. All types of procedures to test the skin are non-invasive and have been used safely in previous clinical studies in babies. Whilst FTIR spectroscopy was used in a previous study conducted by our team in babies (the OBSeRvE study), the investigators will now use a different FTIR instrument. Compared to the benchtop device used for OBSeRvE, the new instrument is better adapted to remote use because of its portability, is safer to use because the measurement head is made of rugged inert materials (diamond and stainless steel) compared to a fragile loop, and the detector is electrically cooled by batteries instead of liquid nitrogen. This device has been tested in humans for safety.

The approach to recruitment of study participants has been informed by the experience of several other clinical studies in babies, including the Barrier Enhancement Eczema Prevention Trial, for which Sheffield has just recently finished recruiting 250 babies. Study recruitment and the skin procedures performed shortly after birth will be led by an experienced Sheffield Teaching Hospitals Research Midwife who is familiar in this clinical environment, and is comfortable with the ethical implications of working with babies and new mothers in the early stages following birth. The Research Midwife will perform the study duties, while remaining sensitive to the needs of the women and babies on the postnatal ward (for example allowing women to breastfeed in peace if requested), and ensuring throughout that maternity service provision will not be adversely affected. The Research Midwife is fully trained in good clinical practice and informed consent. Babies will only be included in the study if the mother's consent is freely provided. Every effort will be made to minimise the burden placed on parents: this means that the researchers will go to the participants to undertake the tests, either at the hospital or at their homes.The researchers will also distribute vouchers to the participants as a "thank you" for their involvement in the study. The voucher amount will be proportionate for their involvement, and is at an appropriate level for the burden of taking part. Taking part is entirely voluntary and the researchers will observe the customs/wishes of the participants. An experienced Research Midwife will lead all hospital assessments, with subsequent follow-up visits being lead by skilled University of Sheffield employed Skin Research Technicians who hold a Sheffield Teaching Hospitals research passport and have undergone a full Disclosure and Barring Services check. All participants will be notified prior to discharge from the maternity ward that the study team conducting home visits consists of both male and female members. If the participant is not happy for a male researcher to conduct a home visit, the researchers will ensure a female member of the team is available as a replacement.

This study includes skin assessments at the participant's home. The research team will complete a lone worker risk assessment and will comply with The University of Sheffield and Sheffield Teaching Hospitals NHS Trust Lone Working guidance. The researchers will issue a study mobile phone for communication during lone working episodes. The researchers have established a set of inclusion and exclusion criteria to ensure that the study is conducted fairly. To ensure that the results are generalizable the researchers have kept the exclusion criteria to a minimum with a geographical restriction centred on the Jessops Wing Maternity Unit established simply for logistical reasons (follow-up sessions being conducted at the participant's homes). The participants will be advised that their data will be held securely, identified only by a unique study number, and that all personal information will be kept strictly confidential. Identifying personal details will be kept only on the study registration form and the Consent form. These documents provide the only link between personal information and the study participant number, and will be kept separately from study data, and stored securely in the STAR study office. Pseudonyms will be used for purposes of transcription and verbatim quotation within any publication. Audio recordings will be destroyed after transcription analysis.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • South Yorkshire
      • Sheffield, South Yorkshire, United Kingdom, S10 SJF
        • Sheffield Teaching Hospitals NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

8 months to 1 year (Child)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Healthy, full-term babies (≥37 weeks gestation) ≤72 hours old

Description

Inclusion Criteria:

Mothers 1) ≥18 years old 2) Carrying singleton pregnancies that are booked in to give birth at The Jessop maternity wing (Sheffield Teaching Hospitals NHS Foundation Trust) 3) Live within a 5 mile radius of The University of Sheffield

Babies:

4) Healthy, full-term babies (≥37 weeks gestation) ≤72 hours old

Exclusion Criteria:

Mothers:

  1. <18 years old
  2. Known to be carrying a baby with a chromosomal abnormality or other syndromic diagnosis
  3. Unable to satisfactory give informed consent for participation
  4. Multiple pregnancies

  5. Live greater than 5 miles from The University of Sheffield

    Babies:

  6. Admission to neonatal unit
  7. Major congenital malformations or limb defects
  8. Illness, social issues or logistical reason that at the discretion of the direct care team, will prevent comfortable trial participation by the family
  9. The baby is to be adopted
  10. Currently participating in an interventional clinical trial that interferes with the STAR study objectives
  11. >72 hours old -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Single arm.
All participants in the same arm.
Diagnostic test: Skin Testing for Atopic eczema

FTIR Spectroscopy. This will involve placing the assessment tool briefly in contact with the baby's skin on the arm and thigh.

Transepidermal Water Loss. This will involve placing a probe on the baby's skin for approximately 60 seconds on the arm and thigh. The probe measures the rate of water loss from the baby's skin, which indicates how well it acts as a barrier.

Collection of skin samples. This will involve collecting surface skin samples using small sticky-tape discs to collect only the very top skin cells that are already dead and about to be shed naturally by the body.

Microbial swab. The researchers will rub the baby's skin gently with a wet sterile swab to collect a sample of the microbes on the baby's skin surface.

Buccal swab / saliva sample. The researchers will collect a sample of the baby's saliva using a buccal swab. This sample will be used to analyse the baby's genes (DNA) to assess their inherited risk of eczema.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
1) Changes in the molecular structure of the skin from birth (≤72 hours old) to 4 weeks (+2 weeks) and 12 months (±1 month) of age assessed by in-vivo ATR-FTIR spectroscopy
Time Frame: at 4 weeks (+2 weeks), and at 12 months of age (± 1
As above
at 4 weeks (+2 weeks), and at 12 months of age (± 1
Changes in skin barrier function from birth (≤72 hours old) to 4 weeks (+2 weeks) and 12 months (±1 month) of age assessed by TEWL (g/m2/h).
Time Frame: from birth (≤72 hours old) to 4 weeks (+2 weeks) and 12 months (±1 month) of age assessed by TEWL (g/m2/h).
As above
from birth (≤72 hours old) to 4 weeks (+2 weeks) and 12 months (±1 month) of age assessed by TEWL (g/m2/h).
Changes in desquamatory protease activity (nU μg-1) from birth (≤72 hours old) to 4 weeks (+2 weeks) and 12 months (±1 month) of age determined by ex-vivo laboratory assay.
Time Frame: (≤72 hours old) and at 4 weeks of age (+2 weeks) to predict onset of eczema by 12 months
As above
(≤72 hours old) and at 4 weeks of age (+2 weeks) to predict onset of eczema by 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of eczema (UK working party diagnosis) and 'skin rashes' (self-reported) in study participants by 12 months of age.
Time Frame: 12 months
As above
12 months
Diagnostic potential of in-vivo ATR-FTIR spectroscopy, TEWL and desquamatory protease activity measured at birth (≤72 hours old) to predict onset of eczema by 12 months of age using mixed model regression analysis.
Time Frame: 12 months
As above
12 months
Diagnostic potential of in-vivo ATR-FTIR spectroscopy, TEWL and desquamatory protease activity measured at 4 weeks (+2 weeks) to predict onset of eczema by 12 months of age using mixed model regression analysis.
Time Frame: measured at 4 weeks (+2 weeks) to predict onset of eczema by 12 months of age using mixed model regression analysis.
As above
measured at 4 weeks (+2 weeks) to predict onset of eczema by 12 months of age using mixed model regression analysis.
Incidence of filaggrin loss-of-function mutations within the study population determined by DNA genotyping, and its relationship with skin barrier development / eczema risk by 12 months of age
Time Frame: 12 months
As above
12 months
Capture of information through participant diaries and questionnaires to determine the interaction between the home environment and how parents care for their baby's skin in relation to skin barrier development / eczema risk by 12 months of age.
Time Frame: 12 months
As above
12 months
Capture of parental satisfaction through participant questionnaires on (i) the potential for early diagnosis of skin conditions, (ii) skin care treatments, and (iii) the skin assessments used by this study
Time Frame: 12 months
As above
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sheffield Teaching Hospitals NHS Foundation Trust

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Sheffield

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Simon G Danby, PhD, BSc, University of Sheffield

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 2, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 12, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 3, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 8, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 18, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STH19479

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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