Short-term Topical Application to Prevent Atopic Dermatitis
Ireland321 participantsStarted 2019-04-16
Plain-language summary
This is a randomised, open-label, controlled study designed to investigate the effect of short-term neonatal skin barrier protection using a commercially available moisturiser on the prevention of atopic dermatitis and food allergy in high risk children.
Who can participate
Age range0 Days – 5 Days
SexALL
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Inclusion Criteria:
* Healthy full-term infants, gestational age \>36+6 weeks.
* Infant has at least one parent with self-reported atopic dermatitis, food allergy, allergic rhinitis or asthma.
* Not requiring admission to the Neonatal Unit.
Exclusion Criteria:
* No parental history of atopic disease.
* Admission to the Neonatal Unit for issues other than the establishment of normal feeding.
* Being administered oral or parenteral antibiotics.
* Receiving phototherapy for hyperbilirubinaemia.
* Sibling, including twin, already recruited.
* Other serious health issues (e.g. abdominal wall defects, congenital heart disease etc.) or a severe widespread skin condition (e.g. collodion).
* Any condition that would make the use of skin barrier protectant inadvisable or not possible (e.g. ankle talipes or developmental dysplasia of the hip, requiring a Pavlik's harness or casts).
* Participation in any other clinical trial of an investigational medicinal product.
What they're measuring
1
Cumulative incidence of atopic dermatitis at 12 months.
Timeframe: 12 months
2
Cumulative incidence of IgE-mediated food allergy at 2 years