| Study characteristics |
| Methods |
Study design: pragmatic, parallel‐group, assessor‐blind, randomised, open‐label, prospective study
Study start date: 1 February 2017
Treatment arms: 2
Follow‐up: patients were followed up until they had eczema or 12 months or were lost to follow‐up |
| Participants |
Participants: N = 54
Inclusion criteria:
Participant (i.e. the newborn baby) must have a parent or sibling with a history of atopic eczema, 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 before 37 weeks' gestation) Child previously randomised to this trial Major congenital anomaly Significant inflammatory skin disease at birth (except seborrhoeic dermatitis) Any immunodeficiency disorder or severe genetic skin disorder Any condition that would make the use of emollients inadvisable or not possible
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| Interventions |
Intervention: in the experimental arm, daily application of Lipikar Baume AP+ emollient and structured parent education
Comparator: control group had no emollient intervention ‐ only structured parent education |
| Outcomes |
Primary outcomes:
Feasibility, safety, and tolerability, and preventive effectiveness Willingness to participate [Time Frame: 2 years] Willingness of parents to have their child randomised and to adhere to the regimen
Secondary outcomes:
Development of AE [Time Frame: 2 years] Cumulative incidence of AE Transepidermal water loss [Time Frame: 2 years] Development of transepidermal water loss over time Microbiome diversity [Time Frame: 2 years] Development of microbiome diversity over time
Adverse events: skin reactions with study product prompted for at follow‐up visits (month 1, month 3, month 6, and month 12) |
| Identification |
Country: Germany
Sponsorship source: University of Schleswig‐Holstein |
| Declarations of interest |
Not reported |
| Notes |
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