Effect of Breast Milk on Diaper Dermatitis in Infants

NCT06699303 | Completed DMC

• 1 other identifier: E-16214662-050.01.04-220310-04
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

Diaper dermatitis, one of infants' most common health problems, can be treated with various methods. One of these methods is breast milk. Studies show that breast milk is a non-harmful, accessible and effective product in the healing of dermatitis. This study was planned to be a randomized, controlled, and single-blinded study to evaluate the effect of breast milk and diaper rash cream containing Hamamelis virginiana (potency 12mg/100g) 5.35 g/100g on the healing process in 0-12-month-old infants with diaper dermatitis. The population of the study consisted of 0-12 months old infants with diaper dermatitis who applied to the Pediatrics Outpatient Clinic of X Hospital. Since not all infants with diaper dermatitis complaints were examined, the number of the population cannot be known. The sample size was calculated as 26 for each group and 52 in total . 30 infants were planned to be included in each group. The licensed IBM SPSS 22.0 (Statistical Package for the Social Sciences) package program will be used for statistical data analysis. Standard deviation, number and percentage will be used in data analysis. Man Whitney U test and Fisher exact test (repeated measures) will be used to evaluate whether there is a difference between independent groups. For the significance level of the data, 0.05 will be used.

Conditions

Diaper Dermatitis

Keywords

diaper dermatitis; mother's milk; hamamelı̇s vı̇rgı̇nı̇nana

Outcome Measures

Primary Outcomes (1)

• It will be evaluated whether there is a difference between breast milk and dermatitis cream in terms of healing diaper dermatitis in babies aged 0-12 months.

  Data will be collected using the baby identification form and the Infant Uncomplicated Diaper Dermatitis Severity Rating Scale (UCDAS).

  6 months

Study Arms (1)

Uncomplicated Diaper Dermatitis Severity Assessment Scale in Babies

EXPERIMENTAL

In the study, a data collection form consisting of 13 questions regarding the sociodemographic characteristics of 0-12 month old babies and the "Uncomplicated Diaper Dermatitis Severity Assessment Scale in Babies, developed by Buckley et al. in 2016 and whose Turkish validity and reliability studies were conducted by Keskin, will be used.

Other: Use of diaper rash cream containing Hamamelis virginiana (potency 12mg/100g) 5.35 g / 100 g for infants in the control group in diaper dermatitis care

Interventions

Use of diaper rash cream containing Hamamelis virginiana (potency 12mg/100g) 5.35 g / 100 g for infants in the control group in diaper dermatitis care OTHER

In diaper dermatitis care, it was planned to use their mothers' milk for the babies in the experimental group and diaper rash cream containing Hamamelis virginiana (potency 12mg/100g) 5.35 g/100g for the babies in the control group. The reason why diaper rash cream containing Hamamelis virginiana (potency 12mg/100g) 5.35 g/100 g is preferred is that it is the most frequently used cream in cases of uncomplicated diaper dermatitis. The mothers of the babies in the control group will be asked to wash and dry the baby's diaper with soap and water during each diaper change and then apply diaper rash cream containing Hamamelis virginiana (potency 12mg/100g) 5.35 g/100 g. Mothers will be asked to record any new signs and symptoms that develop during the treatment and to inform the investigators will be asked to provide information. Positive and negative effects of treatment will also be recorded.

Also known as: Administration of mother's milk for infants in the experimental group in the care of diaper dermatitis

Uncomplicated Diaper Dermatitis Severity Assessment Scale in Babies

Eligibility Criteria

• Age: 1 Month - 6 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Babies fed with breast milk,
• Healthy babies aged 0-6 months,
• Babies who do not have diarrhea or thrush at the time of application,
• Fungus, eczema, allergic disease, etc.Babies without a history of skin disease,
• Babies who do not use antimycotic drugs (Ampotericin etc.), antibiotics and steriods ---before and during the application,
• Babies who do not apply medication or other materials (barrier creams, powder and other medications) to the dermatitis area.

You may not qualify if:

• Babies who are not breastfed
• Those who did not agree to participate in the study

Sponsors & Collaborators

• Sakarya University: lead

Study Sites (2)

Sakarya Training and Research Hospital

Sakarya, Adapzarı, 54100, Turkey (Türkiye)

Location

Sakarya Üniversitesi

Sakarya, Adapzarı, 54100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diaper Rash

Condition Hierarchy (Ancestors)

Dermatitis, Irritant; Dermatitis, Contact; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous

Study Officials

• Döndü 1 Sevimli Güler, PhD

  Sakarya Training and Research Hospital

  PRINCIPAL INVESTIGATOR

• Zekiye 4 Turan, PhD

  Sakarya University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: It was planned as a randomized controlled and single blinded study.

Study Record Dates

• First Submitted: December 25, 2023
• First Posted: November 21, 2024
• Study Start: May 1, 2023
• Primary Completion: January 18, 2024
• Study Completion: May 10, 2024
• Last Updated: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)