Clinical trial NCT05266209: Comparison of Coconut and Sunflower Oil Application in Preserving Babies' Skin Integrity
Official title: Comparison of Coconut and Sunflower Oil Application in Preserving Skin Integrity of Infants in Neonatal Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Care
Keywords: Coconut oil
Sunflower oil
neonatal
Neonatal Intensive Care Unit
skin care
Lead sponsor: Sakarya University
Sponsor class: OTHER
First posted: 2022-03-04
Enrollment: 66
Sex: ALL
Minimum age (years): 34
Maximum age (years): 37
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study was planned to examine the effects of coconut and sunflower oils applied to the skin of newborns on the daily fluid intake and output of the baby, the weight gain/decrease status and skin integrity.

Detailed description: Although there is no consensus on the use of products in daily skin care to maintain the skin integrity of newborns, many products are used. These products; mustard, sunflower, sesame, coconut, olive, soybean, palm oils, ointment (Auqophor), cream (Eucerin) and moisturizers. It is stated that these products prevent skin drying and fissures, maintain skin integrity, and reduce transepidermal fluid loss (Vaseline).

Sunflower oil accelerates the maturation of the skin barrier, there is less weight loss in newborns younger than 35 weeks of gestation who are massaged with sunflower oil compared to the control group, the incidence of nosocomial infections in newborns who receive skin care with sunflower oil is lower than the control group, sunflower oil protects the newborn from infections, olive oil, more effective than oils such as soybean oil and mustard oil; In another study, it was determined that skin care applied to preterm newborns with sunflower oil reduced mortality by 26%, the duration of hospitalization was shorter in newborns treated with sunflower oil than the control group, and regular use of moisturizers had no effect on the incidence of infection. Recently, it has been reported that topical application of coconut oil is safe and feasible in very preterm infants and has beneficial effects on skin condition and recovery of infants. In a systematic review of randomized studies evaluating the effects of topical coconut oil in preterm infants, it was emphasized that in general, transepidermal fluid loss and infection rate were reduced in infants in the coconut oil group, the growth and skin integrity of the infants were better, and no significant side effects were experienced. In a study comparing coconut and carrot oils, it was stated that the skin flora and barrier function were better in babies using coconut oil.

Comparison of the application of Coconut and Sunflower Oil in the preservation of skin integrity, the amount of fluid ingested/extracted daily, and weight gain/decrease in infants hospitalized in the Neonatal Intensive Care Unit.

Eligibility criteria: Inclusion Criteria:

* Voluntary verbal and written consent of the parents of the newborn,
* The gestational week of the newborn is 34 and above,
* The birth weight of the newborn is 2000 g and above,
* The hospitalization of the newborn is the first day of birth.

Exclusion Criteria:

* Unstable clinical condition and vital signs,
* Having a major congenital anomaly,
* High risk of infection due to surgery,
* More than 5% of the body surface is a skin disease,
* External application of medication to the skin in its treatment.

Primary outcomes:
measure: effect on skin integrity
timeFrame: Evaluation with Newborn Skin Condition Evaluation Form (NSCE) form: Evaluations will be made using the YCDD form 48-72 hours after each application (Monday, Thursday, Sunday).
measure: the effect of the baby's weight gain/decrease on 7,14, 21, 28 days
timeFrame: The scale is sensitive enough to measure in very small units.
Secondary outcomes:
Other outcomes:
Locations:
city: Sakarya
country: Turkey
facility: Sakarya Education and Training Hospital
state: Adapazarı
Study officials:
affiliation: Sakarya University
name: NURSAN ÇINAR, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Bilecik Seyh Edebali Universitesi
name: HAMİDE ZENGİN, Asis Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Sakarya University
name: İBRAHİM CANER, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Sakarya University
name: ERTUĞRUL GÜÇLÜ, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Sakarya Education and Research Hospital
name: ÖZNUR TİRYAKİ, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sakarya University
name: MELTEM KARABAY, Asis Prof
role: STUDY_CHAIR
References: