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

NCT05083234 | Completed

• 1 other identifier: 2017-10-01
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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).

Conditions

Neonatal Skin Conditions; Nursing Caries

Keywords

neonate; neonatal skin care; neonatal skin condition score; sunflower seed oil; liquid vaseline

Outcome Measures

Primary Outcomes (1)

• 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

  Change from skin condition score of newborns at 16 days

Study Arms (3)

Sunflower Seed Oil Group (SSO)

EXPERIMENTAL

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

Other: Moisturizing with SSO

Liquid Vaseline Group (LV)

EXPERIMENTAL

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

Other: Moisturizing with LV

Control Group

EXPERIMENTAL

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

Other: The control group was not moisturized.

Interventions

Moisturizing with SSO 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.

Sunflower Seed Oil Group (SSO)

Moisturizing with LV 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.

Liquid Vaseline Group (LV)

The control group was not moisturized. 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.

Control Group

Eligibility Criteria

• Age: 32 Weeks+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maltepe University: lead

Study Sites (1)

Kanuni Sultan Süleyman Research and Training Hospital NICU

Istanbul, Küçükçekmece, 11349921, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 36409190 DERIVED

Study Officials

• Behice Ekici, PhD

  Maltepe University School of Nursing

  STUDY DIRECTOR

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: Assistant Professor, PhD

Model Details: Parallel Assigment,

Study Record Dates

• First Submitted: October 4, 2021
• First Posted: October 19, 2021
• Study Start: April 1, 2019
• Primary Completion: April 20, 2019
• Study Completion: June 25, 2019
• Last Updated: October 19, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)