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

Primary Purpose

Neonatal Skin Conditions, Nursing Caries

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Moisturizing with SSO
Moisturizing with LV
The control group was not moisturized.
Sponsored by
Maltepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Neonatal Skin Conditions focused on measuring neonate, neonatal skin care, neonatal skin condition score, sunflower seed oil, liquid vaseline

Eligibility Criteria

32 Weeks - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Kanuni Sultan Süleyman Research and Training Hospital NICU

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Sunflower Seed Oil Group (SSO)

Liquid Vaseline Group (LV)

Control Group

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Skin condition score of newborns
The NSCS was developed for clinical nurses to use to evaluate infant skin condition. The scale evaluates skin dryness, erythema, and eruption. The best and worst possible scores are 3 and 9, respectively. The scale does not have a cutoff value. High scores indicate poor skin condition, and low scores indicate normal skin condition

Secondary Outcome Measures

Full Information

First Posted
October 4, 2021
Last Updated
October 15, 2021
Sponsor
Maltepe University
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1. Study Identification

Unique Protocol Identification Number
NCT05083234
Brief Title
Maintaining Skin Integrity in Neonates With Sunflower Seed Oil and Liquid Vaseline
Acronym
Neonates
Official Title
Maintaining Skin Integrity in Neonates With Sunflower Seed Oil and Liquid Vaseline: A Prospective Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
April 20, 2019 (Actual)
Study Completion Date
June 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maltepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Skin Conditions, Nursing Caries
Keywords
neonate, neonatal skin care, neonatal skin condition score, sunflower seed oil, liquid vaseline

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assigment,
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sunflower Seed Oil Group (SSO)
Arm Type
Experimental
Arm Description
The skin of newborns in the sunflower seed oil group was moisturized with SSO
Arm Title
Liquid Vaseline Group (LV)
Arm Type
Experimental
Arm Description
The skin of newborns in the liquid vaseline group was moisturized with LV.
Arm Title
Control Group
Arm Type
Experimental
Arm Description
The skin of newborns in the control group was not moisturized.
Intervention Type
Other
Intervention Name(s)
Moisturizing with SSO
Intervention Description
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
Intervention Name(s)
Moisturizing with LV
Intervention Description
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
Intervention Name(s)
The control group was not moisturized.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Skin condition score of newborns
Description
The NSCS was developed for clinical nurses to use to evaluate infant skin condition. The scale evaluates skin dryness, erythema, and eruption. The best and worst possible scores are 3 and 9, respectively. The scale does not have a cutoff value. High scores indicate poor skin condition, and low scores indicate normal skin condition
Time Frame
Change from skin condition score of newborns at 16 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
32 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Behice Ekici, PhD
Organizational Affiliation
Maltepe University School of Nursing
Official's Role
Study Director
Facility Information:
Facility Name
Kanuni Sultan Süleyman Research and Training Hospital NICU
City
Istanbul
State/Province
Küçükçekmece
ZIP/Postal Code
11349921
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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

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