Skin Condition of Term Newborns During Diaper Care for Meconium Removal

NCT ID: NCT07072130

Last Updated: 2025-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-01

Study Completion Date

2025-05-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Infant ALL Skin

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control group (wet cotton)

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

Group Type OTHER

Control group (wet cotton)

Intervention Type 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.

Experimental group (baby oil-impregnated cotton)

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

Group Type EXPERIMENTAL

Experimental group (baby oil-impregnated cotton)

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

1 Day

Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Acibadem University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Zehra Kan Onturk

Assoc. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Zehra Kan Öntürk, Assoc. Prof.

Role: PRINCIPAL_INVESTIGATOR

Acibadem University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Acıbadem University

Istanbul, Ataşehir, Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 30548578 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15180195 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22656391 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34896732 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34060142 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ATADEK 2025-02/77

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Cuff Pressure in Infants
NCT03088761 UNKNOWN