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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

NCT01131403

CompletedN/A

Sponsor: Kathrin HILLMANN

Conditions: Postnatal Skin Physiology

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

Eligibility overview

Sex: ALL

Age: 0 Hours to 48 Hours

Healthy volunteers: Yes

Study type: OBSERVATIONAL

Eligibility 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