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NCT06286813 Clinical Trial

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

Skin Care Clinical Trial

Official title:
The Effect of Almond and Extra Virgin Olive Oils on Maintaining Skin Integrity in Neonates Admitted to the Neonatal Intensive Care Unit

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06286813
Other study ID # Akarakoc
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 2, 2024
Est. completion date May 30, 2024

Study information
Verified date February 2024
Source Marmara University
Contact AYSE KARAKOÇ
Phone +905335695138
Email akarakoc@marmara.edu.tr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Description:

The study was conducted in the Neonatal intensive care unit (NICU) of a training and research hospital.The total number of infants admitted to the NICU was 28. Each nurse is responsible for the care of 3 or 4 newborn babies. Skin are routines in the NICU: A skin condition assessment score is routinely performed every day (09.00 am) in all infants and moisturizing products are used for their skin care. Therefore, there was no control group in the study. Extra virgin olive oil and almond oil are among the skin care products used in the clinic routines. Therefore, the effects of the currently used oils were compared in the study

Recruitment information / eligibility
Status Recruiting
Enrollment 120
Est. completion date May 30, 2024
Est. primary completion date May 3, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 1 Hour to 72 Hours
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - ; Neonates who were discharged before 5 days and required phototherapy were excluded from the study.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Plant (natural) oils
Using 10 ml of plant(natural) oil once a day for daily skin care of newborns

Locations
Country Name City State
Turkey Bakirköy Dr. Sadi Konuk Training and Research Hospital Istanbul

Sponsors (1)
Lead Sponsor Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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