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Skin Condition of Term Newborns During Diaper Care for Meconium Removal

The Effect of Using Two Different Skin Cleansing Cotton Swabs on the Skin Condition of Term Newborns During Diaper Care for Meconium Removal

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07072130
Enrollment
96
Registered
2025-07-18
Start date
2025-04-01
Completion date
2025-05-30
Last updated
2025-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infant ALL, Skin

Keywords

skin care, diaper care, skin condition assessment, meconium, infant, newborn

Brief summary

The aim of this study was to determine the effect of two different skin cleansing cotton wipes on skin condition during meconium removal diaper care in term newborns. The following hypotheses were tested: (a) There is no difference between the effect of using wet cotton and baby oil-impregnated skin cleansing cotton on skin condition during meconium removal diaper care in term newborns. (b) There is a difference between the effect of using wet cotton and baby oil-impregnated skin cleansing cotton on skin condition during meconium removal diaper care in term newborns.

Detailed description

Newborns pass a substance called meconium in the first 24-48 hours through feces. Meconium is a sticky substance consisting of epithelial cells containing green, brown and dark colored mucus. Although meconium can be cleaned with soft tissue wipes that do not contain alcohol and odor or cotton soaked with water, it is difficult to clean because of its adhesive structure. Diaper care practices, wiping, rubbing procedures and materials used during care are important parameters that may threaten skin integrity and should be taken into consideration. In the literature, skin disorders in the diaper area are among the most common skin problems encountered by newborns in the first year. The skin of newborns is different from that of adults. The function of the epidermis is not yet complete and studies have reported that it continues to complete the maturation process in the first year of life. However, the gland area in infants has higher hydration and pH levels than other areas. The change in skin pH affects the ionization level of molecules and topical absorption. Friction and prolonged exposure of this area to feces further increase the skin pH and potentiate the action of skin irritating fecal enzymes. Therefore, it is important to keep the diaper area clean at all times and maintain adequate hydration. It is an important necessity to develop a special method for easier removal of meconium formed in the first days of life without damaging the skin integrity. In this study, skin condition score was evaluated by using wet cotton and baby oil-impregnated skin cleansing cotton during diaper care for meconium removal.

Interventions

OTHERControl group (wet cotton)

The diaper area of the newborns in the control group was cleaned using only cottons moistened with boiled and warmed water. In the preparation stage, the cottons were placed in disposable containers and boiled and warmed water was poured over them to moisten the entire surface of the cottons. Excess water was removed by gently squeezing the cottons. After cleaning, the application was completed by drying the gland area with dry cotton.

OTHERExperimental group (baby oil-impregnated cotton)

Diaper area cleaning of newborns in the experimental group was performed only with cottons impregnated with baby oil. In the preparation of these cottons, a sufficient amount of baby oil was added to the cottons placed in disposable containers and the entire surface of the cottons was allowed to absorb the oil. Excess oil was removed by gently squeezing the cottons. After the cleaning process was completed, the diaper area was dried with dry cotton wool and the process was terminated.

Sponsors

Acibadem University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Days to 28 Days
Healthy volunteers
Yes

Inclusion criteria

* Newborns 38 gestational weeks and older * Healthy newborns * Newborns who defecate their first meconium

Exclusion criteria

* Newborns with abnormal skin condition * Newborns with gastrointestinal tract disease * Newborns with parental history of skin disease * Newborns with developmental delay * Newborns with meconium defecation before the first skin assessment

Design outcomes

Primary

MeasureTime frameDescription
Change in score of skin condition1 hour after birth; immediately after the first meconium diaper care; 3 hours and 6 hours after the first meconium diaper care.The change in these time period will be measured.Skin condition was measured using a validated and reliable skin condition score. The scale consists of three items and each item includes an evaluation criterion. These are dryness, erythema and disruption/peeling of skin integrity, respectively. Each item of the three-point Likert scale is scored from 1 to 3. The lowest score that can be obtained from the scale is 3 and the highest score is 9; a high total score indicates that the skin condition of the newborn is poor.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026