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RecruitingNCT06286813Updated Feb 29, 2024

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

An interventional study of Plant (natural) oils in Skin Care, sponsored by Marmara University. Recruiting at 1 site in Turkey. Open to participants aged 1 Hour to 72 Hours, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-29.

Sponsored by Marmara University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by May 2024, 2 years 5 months ago, but the record still lists the study as recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
1 Hour to 72 Hours
Sex
All
01

Study 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

Read the detailed 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

02

Conditions studied

  • Skin Care

Keywords

  • Newborn, skin care, extra virgin olive oil, almond oil.
03

In context

Lead sponsor

Marmara University is the lead sponsor of 576 studies on the registry; 136 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Hour to 72 Hours
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • ; Neonates who were discharged before 5 days and required phototherapy were excluded from the study.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    Almond oil group

    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

  • Experimental
    Extra Virgin Olive Oil Group

    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

  • OtherPlant (natural) oils

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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 5 days

  2. 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

    Time frame: 5 days

07

Study locations

1 of 1 sites recruiting
  • Bakırköy Dr. Sadi Konuk Training and Research Hospital
    Istanbul, 34854, Turkey
    • AYŞE KARAKOÇ · Contact · akarakoc@marmara.edu.tr · +905335695138
    • Irem Zulal Topçuoglu Arslan · Sub investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — Title of study and method

Supporting information: Study protocol

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06286813
Lead sponsor
Marmara University
Responsible party
Sponsor
First posted
Feb 29, 2024
Start date
Mar 2, 2024 (estimated)
Primary completion
May 3, 2024 (estimated)
Completion
May 30, 2024 (estimated)
Last update
Feb 29, 2024

Study contacts

AYŞE KARAKOÇ
Contact
akarakoc@marmara.edu.tr
+905335695138
AYŞE KARAKOÇ
study director · Marmara University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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