Status:

COMPLETED

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

Lead Sponsor:

University Hospital Schleswig-Holstein

Collaborating Sponsors:

Technische Universität Dresden

Conditions:

Atopic Dermatitis

Eligibility:

All Genders

1-21 years

Phase:

NA

Brief 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, c...

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 ...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

February 1 2017

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 1 2021

Estimated Enrollment :

50 Patients enrolled

Trial Details

Trial ID

NCT03376243

Start Date

February 1 2017

End Date

June 1 2021

Last Update

September 28 2021

Active Locations (1)

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USchleswig-Holstein

Kiel, Scheswig-Holstein, Germany, 24105