EARLYEMOLLIENT - Feasibility of Early Emollient Use in Children With Atopic Eczema
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional

Summary: 
      The aim of this pragmatic, parallel group, assessor-blind randomised open-label prospective
      study is to determine the reasons that motivate parents to enrol or not enrol their child in
      a randomized, controlled basic emollient trial for the prevention of atopic eczema (AE).
      Furthermore, this trial intends to test the hypothesis that daily skin barrier enhancement
      with Lipikar Baume AP+® in newborns at high risk is safe and efficient in preventing AE.

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Detailed description: 
      The aim of this trial is to determine the reasons that motivate parents to enrol or not enrol
      their child in a randomized, controlled basic emollient trial for the prevention of AE.
      Furthermore, this trial intends to test the hypothesis that daily skin barrier enhancement
      with Lipikar Baume AP+® in babies at high risk of allergic disease is safe and to estimate
      the preventive effectiveness of Lipikar Baume AP+® in the prevention of AE in a high risk
      population.

      Objectives:

      The primary objectives are to investigate the

        1. Feasibility:

             1. Parental willingness to enter a child in a controlled primary prevention trial

             2. Compliance with intervention

        2. Safety: incidence of skin-related adverse events and serious adverse events during the
           study

        3. Effectiveness:

             1. Cumulative incidence of AE within 2 years after randomization.

             2. Age of onset of AE

      Study design:

      Pragmatic, parallel group, assessor-blind randomised open-label prospective study of
      emollient use in 50 high-risk neonates starting between days 1 and 21. Child participation in
      the main part of the trial will be 2 years (from within 3 weeks of birth until approximately
      the child's second birthday). This will comprise a 1 year intervention phase then the primary
      outcome is assessed at 2 years.

      Participants:

      Participants will be newborn babies at high risk of developing AE defined as a parent or
      sibling who has (or had) doctor diagnosed asthma, AE or allergic rhinitis.

      Intervention:

      The intervention is daily application of emollient to the baby's entire body surface area
      including the face for the first year of life. Intervention and control group will receive
      structured parent education that comprises general advice on best practice skin care for
      their baby in line with the German AWMF S3 guidelines for allergy prevention and the Federal
      Centre for Health Education.

      Data collection:

      Infants will be examined at scheduled visits at Months 1, 6, 12, and 24. Telephone visits
      were performed at months 3 and 18 to assess for side effects, rashes, and compliance. Daily
      parental recordings will be assessed using electronic data capturing tools.

      Primary Outcomes:

      The primary outcomes will be feasibility, safety and tolerability, and preventive
      effectiveness.
    

Intervention name(s): LIPIKAR BAUME AP+ emollient
Intervention type(s): Other
Intervention description(s): Structured education on prevention guidelines
Intervention MeSH terms: Emollients
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Atopic eczema, prevention