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Feasibility Study of Barrier Enhancement for Eczema Prevention (BEEP)

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ClinicalTrials.gov Identifier: NCT01142999
Recruitment Status : Unknown
Verified June 2010 by Oregon Health and Science University.
Recruitment status was:  Active, not recruiting
First Posted : June 14, 2010
Last Update Posted : August 5, 2011
Sponsor:
Information provided by:
Oregon Health and Science University

June 10, 2010
June 14, 2010
August 5, 2011
May 2010
August 2011   (Final data collection date for primary outcome measure)
Proportion of families willing to be randomized. [ Time Frame: 6 months ]
Determine proportion of families willing to be randomized in order to design larger study in the future.
Feasibility [ Time Frame: 6 months ]
Determine proportion of families willing to be randomized in order to design larger study in the future.
Complete list of historical versions of study NCT01142999 on ClinicalTrials.gov Archive Site
  • Proportion of families eligible for the trial, willing to participate [ Time Frame: 6 months ]
  • Proportion of families who found the interventions acceptable [ Time Frame: 6 months ]
  • Reported adherence with intervention [ Time Frame: 6 months ]
  • Proportion of families for whom the blinding of the assessor to the allocation ostatus was not compromised [ Time Frame: 6 months ]
  • Amount of contamination as a result of increased awareness in the control group [ Time Frame: 6 months ]
  • Percentage of missing data and early withdrawal rates [ Time Frame: 6 months ]
  • Incidence of emollient-related adverse events [ Time Frame: 6 months ]
  • Incidence of eczema at 6 and 12 months [ Time Frame: 12 months ]
  • Age at onset of eczema [ Time Frame: 6 months ]
  • Filaggrin mutation status [ Time Frame: 6 months ]
Not Provided
Not Provided
Not Provided
 
Feasibility Study of Barrier Enhancement for Eczema Prevention
Feasibility Study of Barrier Enhancement for Eczema Prevention (BEEP)
The purpose of this protocol is to determine the feasibility of doing larger follow-up studies examining whether emollients used from birth can prevent eczema in high-risk babies and to help investigators find out if emollients (moisturizing skin creams) used from birth can prevent eczema in high-risk babies. Hypothesis: Enhancing the skin barrier from birth using emollients will prevent or delay the onset of eczema, especially in predisposed infants.
Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Eczema
  • Drug: Sunflower oil
    One group will be instructed to use FDA-approved moisturizers and soap substitutes on their newborn infants.
    Other Name: Moisturizers
  • Drug: Control group
    This group will be asked NOT to use any skin moisturizers and use only soap substitutes on their infants.
  • Drug: Aquaphor ointment
    One group will be instructed to use FDA-approved moisturizers and soap substitutes on their newborn infants.
  • Drug: Cetaphil cream
    One group will be instructed to use FDA-approved moisturizers and soap substitutes on their newborn infants.
  • Active Comparator: Intervention (moisturizer group)
    One group will be instructed to use a choice of 3 FDA-approved moisturizers and soap substitutes on their newborn infants.
    Interventions:
    • Drug: Sunflower oil
    • Drug: Aquaphor ointment
    • Drug: Cetaphil cream
  • Active Comparator: Control group (no moisturizers)
    This group will be asked NOT to use any skin moisturizers and use only soap substitutes on their infants.
    Intervention: Drug: Control group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
46
50
September 2012
August 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Participant must have a parent or sibling with a history of at least one of the following: eczema, allergic rhinitis or asthma
  2. Infant in overall good health
  3. Mother between the ages of 16 and 45 years of age at delivery; infant from birth thru 6 months of age
  4. Capable of giving informed consent

Exclusion Criteria:

  1. Preterm birth defined as birth prior to 37 weeks gestation
  2. Major congenital anomaly
  3. Hydrops fetalis
  4. Significant dermatitis at birth not including seborrheic dermatitis ("cradle cap")
  5. Any immunodeficiency disorder or severe genetic skin disorder
  6. Any other serious condition that would make the use of emollients inadvisable
  7. Any other major medical problems that the investigator deems may increase the risk of adverse events with the intervention
Sexes Eligible for Study: All
up to 6 Months   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01142999
BEEP
No
Not Provided
Not Provided
Eric L. Simpson, M.D., M.C.R., Oregon Health & Science University
Oregon Health and Science University
Not Provided
Principal Investigator: Eric L. Simpson, M.D., M.C.R. Oregon Health and Science University
Oregon Health and Science University
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP