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Effect of Breast Milk on Diaper Dermatitis in Infants

NCT06699303 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-03-11

No results posted yet for this study

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

Interventions

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

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.

Sponsors & Collaborators

  • Sakarya University

    lead OTHER

Principal Investigators

  • Döndü 1 Sevimli Güler, PhD · Sakarya Training and Research Hospital

  • Zekiye 4 Turan, PhD · Sakarya University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
1 Month
Max Age
6 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-05-01
Primary Completion
2024-01-18
Completion
2024-05-10

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06699303 on ClinicalTrials.gov