Condition category
Skin and Connective Tissue Diseases
Date applied
13/05/2015
Date assigned
04/07/2015
Last edited
12/06/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

www.huidhuis.nl/afdeling/neonatale-erythrodermie

Contact information

Type

Scientific

Primary contact

Dr Suzanne Pasmans

ORCID ID

Contact details

Wytemaweg 80
Rotterdam
3015 CA
Netherlands

Type

Scientific

Additional contact

Dr Cuperus Edwin

ORCID ID

Contact details

Burg. 's-Jacobsplein 51
Rotterdam
3013 CA
Netherlands

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

Sponsor information

Organisation

Erasmus Medical Center

Sponsor details

Burg. 's-Jacobdsplein 51
Rotterdam
3013 CA
Netherlands

Sponsor type

Hospital/treatment centre

Website

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

Publication citations

Additional files

Editorial Notes