Diagnose the red baby
| ISRCTN | ISRCTN12831121 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12831121 |
| Secondary identifying numbers | N/A |
- Submission date
- 13/05/2015
- Registration date
- 04/07/2015
- Last edited
- 12/06/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Plain English summary of protocol
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
Contact information
Scientific
Wytemaweg 80
Rotterdam
3015 CA
Netherlands
Scientific
Burg. 's-Jacobsplein 51
Rotterdam
3013 CA
Netherlands
Study information
| Study design | National prospective observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Fast track management of neonatal erythroderma |
| Study objectives | Faster and accurate diagnoses in neonatal erythroderma using a national multidisciplinary protocol, including genetic evaluation with next generation sequencing. |
| Ethics approval(s) | Erasmus Medical Centre, Rotterdam, The Netherlands, 08.005/2014, ref: MEC-2014-208 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/09/2014 |
| Completion date | 31/08/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | Both |
| Target number of participants | 30 |
| Key inclusion criteria | 1. Collodion membrane at birth or 2. Erythroderma at birth or 3. Erythroderma developed in neonatal period (first four weeks postpartum) |
| Key exclusion criteria | Erythroderma developed after the first month postpartum |
| Date of first enrolment | 01/09/2014 |
| Date of final enrolment | 31/08/2016 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Rotterdam
Netherlands
Sponsor information
Hospital/treatment centre
Burg. 's-Jacobdsplein 51
Rotterdam
3013 CA
Netherlands
"ROR" |
https://ror.org/018906e22 |
|---|
Funders
Funder type
Not defined
No information available
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| Publication and dissemination plan | To be confirmed at a later date |
| IPD sharing plan |
