Track topics on Twitter Track topics that are important to you
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.
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
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.
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.
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
- 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.
Observational Model: Case Control, Time Perspective: Prospective
Postnatal Skin Physiology
Charite University, Berlin, Germany
Published on BioPortfolio: 2014-08-27T03:13:22-0400
This study evaluates the safety and efficacy of a skin-to-skin facilitating garment used by mother-infant dyads. It has three phases including researcher observation, randomised controlled...
The study evaluates three best-practice care pathways for postnatal depression (PND) by comparing sole General Practitioner (GP) management to GP management in combination with CBT-based c...
The objective of the present study is to evaluate the effectiveness of postnatal depression screening by comparing the mental health outcome (at 6 months postpartum) of mothers under the E...
Postnatal depression is a common public health problem which has long-term sequelae on the family and the infant's psychosocial development. Interpersonal psychotherapy has demonstrated it...
This single center, randomized, 15-day clinical trial is being conducted to assess the changes to the skin microbiome of induced wounds on the back in approximately 35 healthy adult subjec...
Skin photoaging is primarily caused by the functional attrition of skin stem cells. The skin stem cell niche plays an important role in maintaining stem cell survival and behaviour. In our study, we h...
Accumulation of advanced glycation end-products (AGEs) in skin has been associated with skin aging. Inhibition of glycation of proteins of extracellular matrix may help skin texture and appearance. Th...
Radiation-induced skin fibrosis is a common side effect of clinical radiotherapy. Our previous next-generation sequencing (NGS) study demonstrated the reduced expression of the regulatory α subunit o...
Electrodermal activity (EDA) is a widely used measure in psychophysiological research, and its use in wearable devices has grown in recent times. It is recommended to have proper conditions for EDA me...
The skin provides protection against chemical, physical, and biological stressors, yet the skin morphology changes over the course of life. These changes might affect the skin barrier function and fac...
The measurement of subcutaneous fat located directly beneath the skin by grasping a fold of skin and subcutaneous fat between the thumb and forefinger and pulling it away from the underlying muscle tissue. The thickness of the double layer of skin and subcutaneous tissue is then read with a caliper. The five most frequently measured sites are the upper arm, below the scapula, above the hip bone, the abdomen, and the thigh. Its application is the determination of relative fatness, of changes in physical conditioning programs, and of the percentage of body fat in desirable body weight. (From McArdle, et al., Exercise Physiology, 2d ed, p496-8)
A medical-surgical specialty concerned with the physiology and disorders primarily of the female genital tract, as well as female endocrinology and reproductive physiology.
The care provided a woman following the birth of a child.
The functions of the skin in the human and animal body. It includes the pigmentation of the skin.
Primordial germ cells found in embryonic OOGONIA and postnatal OVARIES.
Anything that breaks the skin is a wound because when the skin is broken, there's a risk of germs getting into the body and causing an infection. Follow and track Wound Care News on BioPortfolio: Wound Car...
Acne Dermatology Eczema Psoriasis Wound Care Dermatology is the medical specialty concerned with the diagnosis and treatment of skin disorders (Oxford Medical Dictionary). As well as studying how the skin works, dermatology covers...
Cytokine Tumour Necrosis Factor (TNF)
TNF is a compound that is classified as a cytokine which plays a central role in the cellular mechanisms of apoptosis or cell death. However, there are a number of different kinds of TNF, just under twenty, but the family of molecules have very similar a...