EARLYEMOLLIENT - Feasibility of Early Emollient Use in Children With Atopic Eczema

Study Overview
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Brief Summary
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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. T

Detailed Description
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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 Feasibility: Parental willingness to enter a child in a controlled primary prevention trial Compliance with intervention Safety: incidence of skin-related adverse events and serious adverse events during the study Effectiveness: Cumulative incidence of AE within 2 years after randomization. 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.

Official Title
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A Pilot Study to Determine the Feasibility of Early Emollient Use in Children With High Risk for Atopic Eczema - EARLYemollient

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Other: LIPIKAR BAUME AP+ emollient


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant (i.e. the newborn baby) must have a parent or sibling with a history of AE, allergic rhinitis or asthma. Infant in overall good health. Term-born babies Mother at least 18 years of age at delivery and capable of giving informed consent. Exclusion Criteria: Preterm birth (defined as birth prior to 37 weeks gestation). Previous child randomised to this trial. Major congenital anomaly. Significant inflammatory skin disease at birth (except seborrheic dermatitis). Any immunodeficiency disorder or severe genetic skin disorder. Any condition that would make the use of emollients inadvisable or not possible.

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 21 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Emollient (LIPIKAR BAUME AP+)<br>Daily application of Lipikar Baume AP+ emollient AND Structured parent education | Other: LIPIKAR BAUME AP+ emollient<br>* Structured education on prevention guidelines<br>|
| No Intervention: Control<br>Only structured parent education | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Willingness to participate | Willingness of parents to get their child randomized and to adhere to the regimen | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of AE | Cumulative incidence of AE | 2 years | 
| Transepidermal water loss | Development of transepidermal water loss over time | 2 years | 
| Microbiome diversity | Development of microbiome diversity over time | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atopic eczema, prevention