Plain English Summary
Background and study aims
Having a red baby is rare and worldwide we don’t know how many red babies are born each year. The redness can be compared to eczema. It’s red, scaly but covered all over the body (>90%).There are many possible underlying causes. One of these causes is disruptions in the human defense mechanism and can result in the death of the baby. Because this risk, it is important to get a fast diagnosis. A good treatment can start soon in most cases. We developed a protocol which can be followed by doctors. With this protocol we believe it will be easier to get a diagnosis.
Who can participate?
Every newborn baby with a red skin or young children with a red skin in which a diagnosis could not be found.
What does the study involve?
Each participant is treated by a clinician. They follow a national protocol, including a skin biopsy and a blood sample for a genetic test.
What are the possible benefits and risks of participating?
There are no risks while following the protocol. A skin biopsy is a little painful, but is very short and will not harm the baby. The protocol may result in a fast diagnosis and thus a fast treatment.
Where is the study run from?
The study runs in the Netherlands, with the Erasmus Medical Centre in Rotterdam as the coordinating Centre. Medical Centres as Maastischt University Medical Centre, Radboud University Medical Centre Nijmegen, University Medical Centre Groningen and the University Medical Centre Utrecht are cooperating in the study as well. Patients can however also be recruited out of other hospitals.
When is the study starting and how long is it expected to run for?
September 2014 to September 2016
Who is funding the study?
The study is funded by NutsOhra and Stichting Coolsingel (Rotterdam, the Netherlands).
Who is the main contact?
Prof. Dr. Suzanne G.M.A. Pasmans
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Fast track management of neonatal erythroderma
Acronym
Study hypothesis
Faster and accurate diagnoses in neonatal erythroderma using a national multidisciplinary protocol, including genetic evaluation with next generation sequencing.
Ethics approval
Erasmus Medical Centre, Rotterdam, The Netherlands, 08.005/2014, ref: MEC-2014-208
Study design
National prospective observational cohort study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Newborn with a collodion membrane or congenital erythroderma or erythroderma developed in the first four weeks after birth.
Intervention
A national multidisciplinary protocol with a diagnostic flowchart will be used. Basic diagnostics include basic laboratory investigations, a skin biopsy and 2x3 ml blood for genetic tests. The genetic test is based on a gene panel (51 genes) accoring to all possible diagnoses in erythrodermic newborns.
Intervention type
Mixed
Phase
Drug names
Primary outcome measures
Clinical characteristics, observed by the clinician, such as erythroderma, collodion membrane, bullae, alopecia etc. These will be measured during first clinical visit. Histological data (skin biopsy) and laboratory findings (normal blood count, total IgE, etc) will be collected. The data for these findings can be different per individual, because not every child/neonate will be seen by a clinician at the same time (e.g. day 1, week 1, etc.).
Secondary outcome measures
Morbidity and mortality
Overall trial start date
01/09/2014
Overall trial end date
31/08/2016
Reason abandoned
Eligibility
Participant inclusion criteria
1. Collodion membrane at birth or
2. Erythroderma at birth or
3. Erythroderma developed in neonatal period (first four weeks postpartum)
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
30
Participant exclusion criteria
Erythroderma developed after the first month postpartum
Recruitment start date
01/09/2014
Recruitment end date
31/08/2016
Locations
Countries of recruitment
Netherlands
Trial participating centre
Erasmus Medical Centre and Sophia Children's Hospital
Burg. 's-Jacobdsplein 51
Rotterdam
Netherlands
Funders
Funder type
Not defined
Funder name
NutsOhra Fund (Fonds NutsOhra) (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Coolsingel Foundation (Stichting Coolsingel( (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
To be confirmed at a later date
Intention to publish date
Participant level data
Stored in repository
Results - basic reporting
Publication summary