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

NCT ID: NCT03143504

Last Updated: 2023-04-18

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 180 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-03-02
• Study Completion Date: 2023-06-30

Brief Summary

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.

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.

Conditions

Atopic Eczema

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Single arm.

All participants in the same arm.

Skin Testing for Atopic eczema

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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 -

• Minimum Eligible Age: 37 Weeks
• Maximum Eligible Age: 13 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Sheffield

OTHER

Sponsor Role: collaborator

Sheffield Teaching Hospitals NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Simon G Danby, PhD, BSc

Role: STUDY_DIRECTOR

University of Sheffield

Locations

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, South Yorkshire, United Kingdom

Countries

United Kingdom

References

Chittock J, Kay L, Brown K, Cooke A, Lavender T, Cork MJ, Danby SG. Association between skin barrier development and early-onset atopic dermatitis: A longitudinal birth cohort study. J Allergy Clin Immunol. 2024 Mar;153(3):732-741.e8. doi: 10.1016/j.jaci.2023.10.017. Epub 2023 Nov 4.

Reference Type: DERIVED

PMID: 37926123 (View on PubMed)

Other Identifiers

STH19479

Identifier Type: -

Identifier Source: org_study_id