Clinical Analysis of the Influence of Using the Skin Care Products on the Diaper Area in Comparison With Using a Cotton Wool Cloth, Moistened With Clear Water on the Skin Physiology of the Newborns From the 1st Day to the 4th Week of Life

This study has been completed.
Sponsor:
Collaborator:
Johnson & Johnson GmbH
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01131403
First received: May 26, 2010
Last updated: June 21, 2011
Last verified: May 2007
  Purpose

Study design:

The purpose of the present study is to analyse of the influence of the application of the skin care products on the diaper area (Factor A) and the application of a cotton wool cloth, moistened with clear water on the diaper area (Faktor B) on the skin barrier function of the newborns during the first four weeks. Additionally, the microbiological colonisation of the skin will be observed. After four weeks all infants in both groups will obtain wet wipe and after 8 weeks a facultative measurement will be performed.

Primary and secondary end points:

In the present study, as a primary end point TEWL on the buttock was chosen, because the significant difference between the infants who were bathed and washed in the previous study was found.

Secondary end points are the TEWL on the other measuring points, pH-value and SCH. Additionally, secondary end points are the D-Squame method and the cytokine measurement with Sebutapes.

Hypotheses:

The intention of the study is to evaluate, whether the using of wet wipe on the diaper area has an influence on the TEWL of the newborns. The following hypotheses are present below:

H0 (Null hypothesis): The TEWL is indistinguishable between infants who get cleaned with wet wipe on the diaper area and infants who get cleaned with a cotton wool cloth, moistened with clear water on the diaper area, i.e.

TEWL clear water is equal TEWL wet wipe against H1 (Alternative hypothesis - bilateral): The TEWL is distinguishable between infants who get cleaned with wet wipe on the diaper area and infants who get cleaned with a cotton wool cloth, moistened with clear water on the diaper area, i.e.

TEWL clear water is not equal TEWL wet wipe


Condition
Postnatal Skin Physiology

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Standardized Skin Care Regimen in the Diaper Area: a Prospective, Randomized Clinical Study on Skin Barrier Function and Epidermal IL-1α

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • TEWL [ Time Frame: second day of life, 14 day of life and 28 day of life ] [ Designated as safety issue: Yes ]
    TEWL= transepidermal waterloss


Secondary Outcome Measures:
  • pH [ Time Frame: second day of life, 14 day of life and 28 day of life ] [ Designated as safety issue: Yes ]
    skin pH

  • SCH [ Time Frame: 2nd, 14th and 28th day of life ] [ Designated as safety issue: Yes ]
    SCH= stratum corneum hydration

  • D-Squame [ Time Frame: 2nd, 14th and 28th day of life ] [ Designated as safety issue: Yes ]
    D-Squame= special adhesive skin foils

  • Interleukin-1α [ Time Frame: 2nd, 14th and 28th day of life ] [ Designated as safety issue: Yes ]
    Interleukin 1 alpha= cytokine

  • microbiological colonisation [ Time Frame: 2nd, 14th and 28th day of life ] [ Designated as safety issue: Yes ]
    microbiological colonisation of umbilical an buttock region


Estimated Enrollment: 44
Study Start Date: May 2007
Estimated Study Completion Date: October 2007
Groups/Cohorts
BW= using baby wipes and CW= using cotton wool
wet wipe, cotton wool
Group 1 (BW),(n= 01-19):Using of wet wipe during the diaper changes Group 2 (CW),(n=20-40):Using a cotton wool cloth, moistened with clear water during the diaper changes.

Detailed Description:

Method and number of subjects:

Monocenter, prospective, randomized study with two parallel groups. To get reliable results, the number of male and female newborns to be included in this study is 40.

The group of 40 healthy full-term newborn babies will be divided into 2 groups:

Number of groups and subjects Application of skin care products

  1. 01-19 Using of wet wipe during the diaper changes
  2. 20-40 Using a cotton wool cloth, moistened with clear water during the diaper changes. The measurement take place at the Clinical Research Center for Hair and Skin Physiology, at the Department of Dermatology, Campus Charité Mitte and also at the Department of Neonatology Campus Charité Mitte, Charité-Universitätsmedizin Berlin.

Study plan:

Application:

All newborns will obtain a standard skin care, according to division into one of the followings groups: it will be used wet wipe during the diaper changes or a cotton wool cloth moistened with clear water. Additionally, the infants of both groups will be bathed twice a week according to following standard schema. The infant will be submerged in bathtub half filled with water, up to the shoulder.The water temperature should be ca. 370C, pH 7.9-8.2 and the bathing should not require longer than 5 minutes.

Inclusion criteria:

All healthy (i.e. meeting none of the non-inclusion criteria) term newborns are possible candidates for the study. The following criteria must be met for enrollment in the study:

  1. Male and female term newborns from 37 completed weeks of gestation, age ≤ 48 hours
  2. Written informed parental consent

Non-inclusion criteria:

  • Any critically ill term newborn, i.e. septic infants, infants born with serious congenital malformation/defects, asphyxia, hydronephrosis, severe intracranial hemorrhage
  • Newborns with known immunodeficiency
  • Newborns with pre-existing skin disease with eruptions covering more than 50% of body surface i.e. congenital ichthyosis, congenital candidiasis
  • Newborn has relevant skin maceration, which influence the measurements or is communicable i.e. urticaria or herpes
  • Any acutely or chronically ill newborn with temperatures below 35°C or above 40°C
  • Newborn is taking part in another study or is during a term of exclusion of a study.
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

group of 40 healthy full-term newborn babies

Criteria

Inclusion Criteria:

  • All healthy (i.e. meeting none of the non-inclusion criteria) term newborns are possible candidates for the study. The following criteria must be met for enrollment in the study:

    1. Male and female term newborns from 37 completed weeks of gestation, age ≤ 48 hours
    2. Written informed parental consent

Exclusion Criteria:

  • Any critically ill term newborn, i.e. septic infants, infants born with serious congenital malformation/defects, asphyxia, hydronephrosis, severe intracranial hemorrhage

    • Newborns with known immunodeficiency
    • Newborns with pre-existing skin disease with eruptions covering more than 50% of body surface i.e. congenital ichthyosis, congenital candidiasis
    • Newborn has relevant skin maceration, which influence the measurements or is communicable i.e. urticaria or herpes
    • Any acutely or chronically ill newborn with temperatures below 35°C or above 40°C
    • Newborn is taking part in another study or is during a term of exclusion of a study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01131403

Sponsors and Collaborators
Charite University, Berlin, Germany
Johnson & Johnson GmbH
Investigators
Principal Investigator: Ulrike Blume-Peytavi, MD, PhD Department of Dermatology, Charite-Universitätsmedizin, Berlin
  More Information

No publications provided

Responsible Party: Ulrike Blume-Peytavi, PhD, MD, Clinical Research Center for Hair and Skin Science, Department of Dermatology and Allergy, Charité-Universitätsmedizin Berlin
ClinicalTrials.gov Identifier: NCT01131403     History of Changes
Other Study ID Numbers: CRC/wet wipe
Study First Received: May 26, 2010
Last Updated: June 21, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by Charite University, Berlin, Germany:
IL-1α, skin care; baby wet wipes; full-term newborn; skin barrier function

ClinicalTrials.gov processed this record on October 22, 2014