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Maintaining Skin Integrity in Neonates With Sunflower Seed Oil and Liquid Vaseline

NCT ID: NCT05083234

Last Updated: 2021-10-19

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-01

Study Completion Date

2019-06-25

Brief Summary

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In this randomized controlled study, 90 preterm and term neonates in the NICU of a state hospital were equally divided into 3 groups. The skin integrity of the newborns in all three groups was assessed in terms of the Neonatal Skin Condition Score (NSCS), which was performed a total of 9 times at 48-hour intervals. The skin of the newborns in the first group was moisturized with SSO and with LV in the second group, once a day, a total of 17 times. Moisturizer was not applied to the skin of the third group of newborns (the control group).

Detailed Description

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Because the barrier function of the skin of the newborn is still immature, disruption of skin integrity is a commonly observed problem. The purpose of the study was to test the applicability and effectiveness of sunflower seed oil (SSO) and Liquid Vaseline (LV) in maintaining skin integrity in term and preterm neonates in the Neonatal Intensive Care Unit (NICU). The sample size of the study has been determined by the power analysis (G\*Power 3.1.9.2), The sample size was found to be a total of 66 neonates including minimum of 22 neonates for each group. It was estimated that case losses may occur and therefore, it was decided to conduct the study with a total of 90 neonates including 30 neonates in three groups. Assignment of neonates to research groups was done according to the order of hospitalization in the NICU. The first hospitalized neonates SSO, the second hospitalized LV, and the third hospitalized were included in the control group. The groups were repeated until they were complete. Weighing the neonate, taking vital signs, evaluating the skin condition, wiping the whole body, and stabilizing the general condition of the neonate before moisturizing the skin were taken into account. Neonates Information Form(NIF) and Neonatal Skin Condition Score (NSCS) were used for data collection. Parents of neonates were informed about the study. First day of hospitalization; Demographic data and medical history of the neonate in the study or control group were obtained from the patient file records. The neonate was weighed, vital signs were taken, and the data were recorded in the NIF.

The body of all neonates in the research or control group was wiped on the 1st day of hospitalization. In the following days, it was repeated 2 times a week (Monday and Friday) in the same way.The skin condition of the neonate in the research or control group was evaluated with the NSCS scale. The first skin evaluation was performed on the 1st day of hospitalization (1st NSCS). Skin condition was re-evaluated at 48 hour intervals in the following days. Skin condition of the neonate in the control or research group was evaluated a total of 9 times with 48-hour intervals. After the initial skin condition assessment, the neonate's skin is moistened with SSO or LV, depending on the group. It was rehydrated once a day (24 hours apart) in the following days.

Conditions

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Neonatal Skin Conditions Nursing Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel Assigment,
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Sunflower Seed Oil Group (SSO)

The skin of newborns in the sunflower seed oil group was moisturized with SSO

Group Type EXPERIMENTAL

Moisturizing with SSO

Intervention Type OTHER

Vital signs of newborns in the sunflower seed oil group were measured. The skin of newborns in the sunflower seed oil group was wiped without rubbing. The skin of newborns in the sunflower seed oil group was evaluated with the NSCS scale.

Liquid Vaseline Group (LV)

The skin of newborns in the liquid vaseline group was moisturized with LV.

Group Type EXPERIMENTAL

Moisturizing with LV

Intervention Type OTHER

Vital signs of newborns in the liquid vaseline group were measured. The skin of newborns in the liquid vaseline group was wiped without rubbing. The skin of newborns in the liquid vaseline group was evaluated with the NSCS scale.

Control Group

The skin of newborns in the control group was not moisturized.

Group Type EXPERIMENTAL

The control group was not moisturized.

Intervention Type OTHER

Vital signs of newborns in the control group were measured. The skin of newborns in the control group was wiped without rubbing. The skin of newborns in the control group was evaluated with the NSCS scale.

Interventions

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Moisturizing with SSO

Vital signs of newborns in the sunflower seed oil group were measured. The skin of newborns in the sunflower seed oil group was wiped without rubbing. The skin of newborns in the sunflower seed oil group was evaluated with the NSCS scale.

Intervention Type OTHER

Moisturizing with LV

Vital signs of newborns in the liquid vaseline group were measured. The skin of newborns in the liquid vaseline group was wiped without rubbing. The skin of newborns in the liquid vaseline group was evaluated with the NSCS scale.

Intervention Type OTHER

The control group was not moisturized.

Vital signs of newborns in the control group were measured. The skin of newborns in the control group was wiped without rubbing. The skin of newborns in the control group was evaluated with the NSCS scale.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Parents giving verbal and written consent,
* Hospitalized in the NICU within the first 24 hours after birth,
* With a birth weight of more than 1500 g,
* No life-threatening health problems and skin diseases.

Exclusion Criteria

* Gestational age less than 32 weeks,
* Parents who do not give verbal and written permission,
* Hospitalized in the NICU after the first 24 hours after birth,
* With a birth weight of less than 1500 g,
* Having life-threatening health problems and skin diseases.
Minimum Eligible Age

32 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Maltepe University

OTHER

Sponsor Role lead

Responsible Party

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Behice Ekici

Assistant Professor, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Behice Ekici, PhD

Role: STUDY_DIRECTOR

Maltepe University School of Nursing

Locations

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Kanuni Sultan Süleyman Research and Training Hospital NICU

Istanbul, Küçükçekmece, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Karakoc IB, Ekici B. Maintaining Skin Integrity in Neonates with Sunflower Seed Oil and Liquid Vaseline: A Prospective Randomized Controlled Study. Adv Skin Wound Care. 2022 Dec 1;35(12):1-8. doi: 10.1097/01.ASW.0000891080.13305.75.

Reference Type DERIVED
PMID: 36409190 (View on PubMed)

Other Identifiers

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2017-10-01

Identifier Type: -

Identifier Source: org_study_id