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

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

• 01-19 Using of wet wipe during the diaper changes
• 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:

• Male and female term newborns from 37 completed weeks of gestation, age ≤ 48 hours
• 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.

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:

• Male and female term newborns from 37 completed weeks of gestation, age ≤ 48 hours
• 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