Comparison of Coconut and Sunflower Oil Application in Preserving Babies' Skin Integrity

Skin Care Clinical Trial

Official title:

Comparison of Coconut and Sunflower Oil Application in Preserving Skin Integrity of Infants in Neonatal Intensive Care Unit

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05266209
• Other study ID #: 0
• Status: Completed
• Phase: N/A
• Start date: March 25, 2022
• Est. completion date: May 12, 2023

Study information

• Verified date: May 2023
• Source: Sakarya University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: May 12, 2023
• Est. primary completion date: February 25, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 34 Weeks to 37 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Skin Care

Intervention

Other:
• Coconut oil skin care group
No special technique was used for sample selection, random sample selection will be made. In the evaluation made according to the large effect size, the number of samples determined for Power: 0.80, :0.20 and :0.05 was determined as 66, with a minimum of 22 for each group. Calculations were made in computer environment using Power analysis (G*Power 3.1.9.2) program. Random selection method will be used while creating research groups. Coconut oil, sunflower oil and control groups will be formed according to the order of admission to the unit. E.g; Coconut oil is planned for the first hospitalized newborn, sunflower oil for the second newborn, and third hospitalized newborn control group. This order will be repeated until a sufficient number of cases is reached when the newborns are included in the groups.

Locations

Country	Name	City	State
Turkey	Sakarya Education and Training Hospital	Sakarya	Adapazari

Sponsors (1)

Lead Sponsor	Collaborator
Sakarya University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	effect on skin integrity	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).; Skin condition scoring of the newborn; It is performed according to the presence of signs of redness, dryness and deterioration of skin integrity/peeling. It was developed in a three-point Likert format and each item/finding is given a score from 1 to 3. The lowest score that can be obtained as a result of the evaluation is 3, and the highest score is 9. A total score higher than 3 indicates that there is a risk of deterioration of the skin integrity of the newborn, while a high score indicates that the newborn's skin condition is poor.	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).
Primary	the effect of the baby's weight gain/decrease on 7,14, 21, 28 days	The baby's weight will be measured on days 7, 14, 21, 28, naked and without diapers.	The scale is sensitive enough to measure in very small units.