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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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17 October 2016 |
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Main ID: |
ISRCTN12831121 |
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Date of registration:
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04/07/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Diagnose the red baby
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Scientific title:
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Fast track management of neonatal erythroderma |
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Date of first enrolment:
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01/09/2014 |
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Target sample size:
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30 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN12831121 |
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Study type:
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Observational |
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Study design:
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National prospective observational cohort study (Diagnostic)
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Phase:
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Countries of recruitment
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Netherlands
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Contacts
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Name:
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Suzanne
Pasmans |
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Address:
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Wytemaweg 80
3015 CA
Rotterdam
Netherlands |
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Telephone:
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Email:
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Affiliation:
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Name:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Collodion membrane at birth or
2. Erythroderma at birth or
3. Erythroderma developed in neonatal period (first four weeks postpartum)
Exclusion criteria: Erythroderma developed after the first month postpartum
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Newborn with a collodion membrane or congenital erythroderma or erythroderma developed in the first four weeks after birth.
Skin and Connective Tissue Diseases
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Intervention(s)
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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.
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Primary Outcome(s)
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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.).
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Secondary Outcome(s)
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Morbidity and mortality
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Source(s) of Monetary Support
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NutsOhra Fund (Fonds NutsOhra) (Netherlands), Coolsingel Foundation (Stichting Coolsingel( (Netherlands)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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