Ignite Creation Date:
2024-05-06 @ 10:02 AM
Last Modification Date:
2024-10-26 @ 12:23 PM
Study NCT ID:
NCT03143504
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-04-18
First Post:
2017-04-12
Brief Title:
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
Sponsor:
Sheffield Teaching Hospitals NHS Foundation Trust
Organization:
Sheffield Teaching Hospitals NHS Foundation Trust
Study Overview
Official Title:
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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STAR
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 babys 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
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 babys 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 structurefunction 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 babys 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 mothers 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 homesThe 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 customswishes 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 participants 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 participants 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
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 babys 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 mothers 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 homesThe 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 customswishes 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 participants 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 participants 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None