The Effect of Almond and Extra Virgin Olive Oils on Maintaining Skin Integrity in Neonates

NCT06286813 | Recruiting

• 1 other identifier: Akarakoc
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to evaluate the effects of extra virgin olive and almond oils on maintaining skin integrity in neonates admitted to the neonatal intensive care unit. Interventional research with two parallel groups and no control group

Conditions

Skin Care

Keywords

Newborn, skin care, extra virgin olive oil, almond oil.

Outcome Measures

Primary Outcomes (2)

• Neonatal skin condition score

  This is a three-point Likert-type scale to evaluate dryness, redness, peeling / deterioration in newborn baby skin. For each criterion in the evaluation of the scale score; 1 refers to the best and 3 to the worst skin condition. The highest and lowest scores on the scale are 9 and 3, respectively. A higher scale score indicates poorer skin condition

  5 days

• Skin moisture meter(DMM):

  The product shows the moisture level (0%-99.9%) in contact with the skin and does not harm the skin. It provides measurement results with high precision

  5 days

Study Arms (2)

Almond oil group

EXPERIMENTAL

On the first day of neonates' admission to the clinic, their skin condition will be evaluated using the NSCS, and the hydration of skin will be measured using a digital moisture meter with the recommended usage guide. During morning care at 09:00 a.m., almond oil (10 ml) will be applied to their entire body, except for the head. Three hours after the application, at 12:00 a.m., their skin condition will be assessed, and the hydration will be measured and recorded. This application will continue for 5 days.

Other: Plant (natural) oils

Extra Virgin Olive Oil Group

EXPERIMENTAL

On the first day of neonates' admission to the clinic, their skin condition will be evaluated using the NSCS, and the hydration of skin will be measured using a digital moisture meter with the recommended usage guide. During morning care at 09:00 a.m., extra virgin olive oil(10 ml) will be applied to their entire body, except for the head. Three hours after the application, at 12:00 a.m., their skin condition will be assessed, and the hydration will be measured and recorded. This application will continue for 5 days.

Other: Plant (natural) oils

Interventions

Plant (natural) oils OTHER

Using 10 ml of plant(natural) oil once a day for daily skin care of newborns

Almond oil group; Extra Virgin Olive Oil Group

Eligibility Criteria

• Age: 1 Hour - 72 Hours
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Neonates who were born at 37-42 weeks of gestation, were planned to be hospitalized in the NICU for at least 5 days, had a post-natal age of 0-72 hours, and were received written and verbal consent from parents were included in the study.

You may not qualify if:

• ; Neonates who were discharged before 5 days and required phototherapy were excluded from the study.

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Bakırköy Dr. Sadi Konuk Training and Research Hospital

Istanbul, 34854, Turkey (Türkiye)

RECRUITING

Related Publications (1)

• Topcuoglu Arslan IZ, Karakoc A. Effect of Almond and Extra Virgin Olive Oils on Maintaining Skin Integrity in Neonates Admitted to the Neonatal Intensive Care Unit. Adv Skin Wound Care. 2025 Aug 1;38(7):381-386. doi: 10.1097/ASW.0000000000000306. Epub 2025 Apr 4.

  PMID: 40184517 DERIVED

MeSH Terms

Interventions

Oils

Intervention Hierarchy (Ancestors)

Lipids

Study Officials

• AYŞE KARAKOÇ

  Marmara University

  STUDY DIRECTOR

Central Study Contacts

AYŞE KARAKOÇ

CONTACT

+905335695138; akarakoc@marmara.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Interventional research with two parallel groups (almond olive group and virgin olive oil group) and no control group.

Study Record Dates

• First Submitted: February 9, 2024
• First Posted: February 29, 2024
• Study Start: March 2, 2024
• Primary Completion: May 3, 2024
• Study Completion: May 30, 2024
• Last Updated: February 29, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: starting 3 months after publication
• Access Criteria: with e-mail (akarakoc@marmara.edu.tr)

Locations

TU (1)