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 | Completed DMC

• 1 other identifier: CRC/wet wipe
• Study Type: observational
• Target: 44
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Postnatal Skin Physiology

Keywords

IL-1α, skin care; baby wet wipes; full-term newborn; skin barrier function

Outcome Measures

Primary Outcomes (1)

• TEWL

  TEWL= transepidermal waterloss

  second day of life, 14 day of life and 28 day of life

Secondary Outcomes (5)

• pH

  second day of life, 14 day of life and 28 day of life

• SCH

  2nd, 14th and 28th day of life

• D-Squame

  2nd, 14th and 28th day of life

• Interleukin-1α

  2nd, 14th and 28th day of life

• microbiological colonisation

  2nd, 14th and 28th day of life

Study Arms (2)

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.

Eligibility Criteria

• Age: 0 Hours - 48 Hours
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

group of 40 healthy full-term newborn babies

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kathrin HILLMANN: lead
• Johnson & Johnson GmbH: collaborator

Study Officials

• Ulrike Blume-Peytavi, MD, PhD

  Department of Dermatology, Charite-Universitätsmedizin, Berlin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr. med.

Study Record Dates

• First Submitted: May 26, 2010
• First Posted: May 27, 2010
• Study Start: May 1, 2007
• Primary Completion: October 1, 2007
• Study Completion: October 1, 2007
• Last Updated: February 13, 2025

Record last verified: 2007-05