Skin Condition of Term Newborns During Diaper Care for Meconium Removal

NCT07072130 | Completed

• 1 other identifier: ATADEK 2025-02/77
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Infant ALL; Skin

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in score of skin condition

  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.

  1 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.

Study Arms (2)

Control group (wet cotton)

OTHER

The newborns whose meconium-stained diapers were cleaned with wet cotton comprised the control group.

Other: Control group (wet cotton)

Experimental group (baby oil-impregnated cotton)

EXPERIMENTAL

The newborns whose meconium-stained diapers were cleaned with baby oil-impregnated cotton comprised the experimental group

Other: Experimental group (baby oil-impregnated cotton)

Interventions

Control group (wet cotton) OTHER

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.

Control group (wet cotton)

Experimental group (baby oil-impregnated cotton) OTHER

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.

Experimental group (baby oil-impregnated cotton)

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Acibadem University: lead

Study Sites (1)

Acıbadem University

Istanbul, Ataşehir, 34758, Turkey (Türkiye)

Location

Related Publications (5)

• Kusari A, Han AM, Virgen CA, Matiz C, Rasmussen M, Friedlander SF, Eichenfield DZ. Evidence-based skin care in preterm infants. Pediatr Dermatol. 2019 Jan;36(1):16-23. doi: 10.1111/pde.13725. Epub 2018 Dec 12.

  PMID: 30548578 BACKGROUND

• Lund CH, Osborne JW. Validity and reliability of the neonatal skin condition score. J Obstet Gynecol Neonatal Nurs. 2004 May-Jun;33(3):320-7. doi: 10.1177/0884217504265174.

  PMID: 15180195 BACKGROUND

• Lavender T, Furber C, Campbell M, Victor S, Roberts I, Bedwell C, Cork MJ. Effect on skin hydration of using baby wipes to clean the napkin area of newborn babies: assessor-blinded randomised controlled equivalence trial. BMC Pediatr. 2012 Jun 1;12:59. doi: 10.1186/1471-2431-12-59.

  PMID: 22656391 BACKGROUND

• Brandon DH, Hatch D, Barnes A, Vance AJ, Harney J, Voigtman B, Younge N. Impact of diaper change frequency on preterm infants' vital sign stability and skin health: A RCT. Early Hum Dev. 2022 Jan;164:105510. doi: 10.1016/j.earlhumdev.2021.105510. Epub 2021 Nov 20.

  PMID: 34896732 BACKGROUND

• Gustin J, Bohman L, Ogle J, Fadayel G, Mitchell MC, Narendran V, Visscher MO, Carr AN. Improving newborn skin health: Effects of diaper care regimens on skin pH and erythema. Pediatr Dermatol. 2021 Jul;38(4):768-774. doi: 10.1111/pde.14602. Epub 2021 May 31.

  PMID: 34060142 BACKGROUND

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Zehra Kan Öntürk, Assoc. Prof.

  Acibadem University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Study Record Dates

• First Submitted: July 9, 2025
• First Posted: July 18, 2025
• Study Start: April 1, 2025
• Primary Completion: May 30, 2025
• Study Completion: May 30, 2025
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)