Clinical trial NCT06699303: Effect of Breast Milk on Diaper Dermatitis in Infants
Official title: Study of the Effect of Breast Milk and Hamamelis Virginiana (Potency12MG/100G) on the Healing of Diaper Dermatitis in Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diaper Dermatitis
Keywords: diaper dermatitis
mother's milk
hamamelı̇s vı̇rgı̇nı̇nana
Lead sponsor: Sakarya University
Sponsor class: OTHER
First posted: 2024-11-21
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: It was planned as a randomized controlled and single blinded study.
Primary purpose: TREATMENT

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.

Detailed description: Diaper dermatitis, one of the most common health problems in infants, can be treated with various methods (Blume-Peytavi Kanti, 2018; Gozen et al., 2014; Seifi, Jalali, Heidari, 2017). One of these methods is breast milk. Breast milk has strong immunologic properties that protect infants from respiratory diseases, middle ear infections and gastrointestinal system diseases. It also has protective effects against diabetes mellitus, obesity, hyperlipidemia, hypertension, cardiovascular diseases, autoimmunity and asthma. Because of these positive properties, breast milk has lifelong positive effects. In recent years, studies on the effect of breast milk in the treatment of dermatitis have been increasing (Kasrae, Farahani, Yousefi, 2015, Blume-Peytavi Kanti, 2018; Gozen et al., 2014; Seifi, Jalali, Heidari, 2017, Bener et al., 2007). In a study conducted by Gozen et al. using breast milk and barrier cream, barrier cream was found to be more effective than breast milk, especially in the treatment of moderate and severe dermatitis (Gozen et al., 2014). Farahani et al. applied 1% hydrocortisol and breast milk for 7 days in a randomized controlled study on diaper dermatitis. In this study, improvement was found to be similar on the 3rd and 7th days of treatment and it was concluded that breast milk was safe and effective (Farahani, Ghobadzadeh, Yousefi, 2013) Seifi et al. found a statistically significant difference between the groups in favor of breast milk in terms of skin rash score on the first and third days of the application in their study using breast milk in diaper rash care (p=0.013, p=0.005, respectively). This difference was even more significant on the fifth day (p=0.004, p=0.001) (Seifi et al., 2017). Studies show that breast milk is a non-harmful, free and effective product for 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 . 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 with the "A priori. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

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

Primary outcomes:
measure: 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.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sakarya
country: Turkey
facility: Sakarya Training and Research Hospital
state: Adapzarı
city: Sakarya
country: Turkey
facility: Sakarya Üniversitesi
state: Adapzarı
Study officials:
affiliation: Sakarya Training and Research Hospital
name: Döndü 1 Sevimli Güler, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sakarya University
name: Zekiye 4 Turan, PhD
role: STUDY_DIRECTOR
References: