Skin Condition of Term Newborns During Diaper Care for Meconium Removal
NCT ID: NCT07072130
Last Updated: 2025-07-18
Study Results
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Basic Information
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COMPLETED
NA
96 participants
INTERVENTIONAL
2025-04-01
2025-05-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Control group (wet cotton)
The newborns whose meconium-stained diapers were cleaned with wet cotton comprised the control group.
Control 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.
Experimental group (baby oil-impregnated cotton)
The newborns whose meconium-stained diapers were cleaned with baby oil-impregnated cotton comprised the experimental group
Experimental 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.
Interventions
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Control 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.
Experimental 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.
Eligibility Criteria
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Inclusion Criteria
* Healthy newborns
* Newborns who defecate their first meconium
Exclusion Criteria
* 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
1 Day
28 Days
ALL
Yes
Sponsors
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Acibadem University
OTHER
Responsible Party
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Zehra Kan Onturk
Assoc. Prof.
Principal Investigators
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Zehra Kan Öntürk, Assoc. Prof.
Role: PRINCIPAL_INVESTIGATOR
Acibadem University
Locations
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Acıbadem University
Istanbul, Ataşehir, Turkey (Türkiye)
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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ATADEK 2025-02/77
Identifier Type: -
Identifier Source: org_study_id
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