Skin CareNCT05266209
Comparison of Coconut and Sunflower Oil Application in Preserving Babies' Skin Integrity
A study testing Coconut oil skin care group in people with Skin Care, run by Sakarya University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 34 to 37 weeksHealthy volunteers can take part
- Conditions the study is for
- Skin Care
- What is being tested?
- Coconut oil skin care group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Mar 2022to 12 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 34 to 37 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sakarya Education and Training Hospital
Sakarya, Adapazarı, 54050
About this study
Official title: Comparison of Coconut and Sunflower Oil Application in Preserving Skin Integrity of Infants in Neonatal Intensive Care Unit
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.
Read the 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.
- Conditions
- Skin Care
- Being tested
- Coconut oil skin care group
- Keywords
- Coconut oil, Sunflower oil, neonatal, Neonatal Intensive Care Unit, skin care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coconut oil skin care groupOther
Also called sunflower 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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental (coconut oil group) | Experimental | Before moistening, the skin of newborns is evaluated using the Newborn Skin Condition Evaluation Form form.
Moisturizers are applied to the thorax, back, arms and legs by massage, respectively, and the skin is absorbed. If it is to be applied for the first time, it is applied to a small area of the body under the control of a doctor. If there is no reaction, it is applied by massaging other areas. Since the babies to be included in the sample group are borderline and moderately premature (34-37W), 3-4 ml/kg (coconut oil)moisturizer will be applied.
Evaluation with NSCE form: Evaluations will be made using the NSCE form 48-72 hours after each application (Monday, Thursday, Sunday). Routine care will be applied to the skin of the newborns in the control group in the hospital. The control group will be evaluated using the NSCE form 3 days a week (Monday, Thursday, Sunday). Receives: Other: Coconut oil skin care group |
| Experimental (sunflower oil group) | Other | Before moistening, the skin of newborns is evaluated using the Newborn Skin Condition Evaluation Form form.
Moisturizers are applied to the thorax, back, arms and legs by massage, respectively, and the skin is absorbed. If it is to be applied for the first time, it is applied to a small area of the body under the control of a doctor. If there is no reaction, it is applied by massaging other areas. Since the babies to be included in the sample group are borderline and moderately premature (34-37W), 3-4 ml/kg (sunflower oil) moisturizer will be applied.
Evaluation with NSCE form: Evaluations will be made using the NSCE form 48-72 hours after each application (Monday, Thursday, Sunday). Receives: Other: Coconut oil skin care group |
| No Intervention (Control group) | No intervention | Before moistening, the skin of newborns is evaluated using the Newborn Skin Condition Evaluation Form form. Routine maintenance of the intensive care unit will be implemented. Evaluation with NSCE form: Evaluations will be made using the NSCE form 48-72 hours after each application (Monday, Thursday, Sunday). Routine care will be applied to the skin of the newborns in the control group in the hospital. The control group will be evaluated using the NSCE form 3 days a week (Monday, Thursday, Sunday) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
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.
Measured: The scale is sensitive enough to measure in very small units.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2022
- Study start25 Mar 2022
- Primary completion25 Feb 2023
- Study completion12 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin CareStudies of the same condition, open and under way.
- More trials run by Sakarya UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, öznur tiryaki, Sakarya University
- Investigators
- NURSAN ÇINAR, Prof, Principal investigator, Sakarya UniversityHAMİDE ZENGİN, Asis Prof, Principal investigator, Bilecik Seyh Edebali UniversitesiİBRAHİM CANER, Prof, Principal investigator, Sakarya UniversityERTUĞRUL GÜÇLÜ, Prof, Principal investigator, Sakarya UniversityÖZNUR TİRYAKİ, PhD, Principal investigator, Sakarya Education and Research HospitalMELTEM KARABAY, Asis Prof, Study chair, Sakarya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05266209
- Sponsor's protocol ID
- 0
- Status last verified
- May 2023
- First submitted
- 2 Feb 2022
- Last updated
- 16 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Coconut and Sunflower Oil Application in Preserving Skin Integrity of Infants in Neonatal Intensive Care Unit
- ClinicalTrials.gov ID
- NCT05266209
- Acronym / sponsor ID
- 0
- Conditions
- Skin Care
- Keywords
- Coconut oil, Sunflower oil, neonatal, Neonatal Intensive Care Unit, skin care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 25 Mar 2022 (actual)
- Primary completion
- 25 Feb 2023 (actual)
- Study completion
- 12 May 2023 (actual)
- First posted
- 4 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Experimental (coconut oil group) | Experimental | Other: Coconut oil skin care groupBefore moistening, the skin of newborns is evaluated using the Newborn Skin Condition Evaluation Form form. Moisturizers are applied to the thorax, back, arms and legs by massage, respectively, and the skin is absorbed. If it is to be applied for the first time, it is applied to a small area of the body under the control of a doctor. If there is no reaction, it is applied by massaging other areas. Since the babies to be included in the sample group are borderline and moderately premature (34-37W), 3-4 ml/kg (coconut oil)moisturizer will be applied. Evaluation with NSCE form: Evaluations will be made using the NSCE form 48-72 hours after each application (Monday, Thursday, Sunday). Routine care will be applied to the skin of the newborns in the control group in the hospital. The control group will be evaluated using the NSCE form 3 days a week (Monday, Thursday, Sunday). |
| Experimental (sunflower oil group) | Other | Other: Coconut oil skin care groupBefore moistening, the skin of newborns is evaluated using the Newborn Skin Condition Evaluation Form form. Moisturizers are applied to the thorax, back, arms and legs by massage, respectively, and the skin is absorbed. If it is to be applied for the first time, it is applied to a small area of the body under the control of a doctor. If there is no reaction, it is applied by massaging other areas. Since the babies to be included in the sample group are borderline and moderately premature (34-37W), 3-4 ml/kg (sunflower oil) moisturizer will be applied. Evaluation with NSCE form: Evaluations will be made using the NSCE form 48-72 hours after each application (Monday, Thursday, Sunday). |
| No Intervention (Control group) | No intervention | –Before moistening, the skin of newborns is evaluated using the Newborn Skin Condition Evaluation Form form. Routine maintenance of the intensive care unit will be implemented. Evaluation with NSCE form: Evaluations will be made using the NSCE form 48-72 hours after each application (Monday, Thursday, Sunday). Routine care will be applied to the skin of the newborns in the control group in the hospital. The control group will be evaluated using the NSCE form 3 days a week (Monday, Thursday, Sunday) |
Who may qualify
- Ages
- 34 to 37 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coconut oil skin care groupAlso: sunflower oil skin care groupNo 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. | Other | Experimental (coconut oil group), Experimental (sunflower oil group) |
Primary outcome
effect on skin integrity
Time frame: 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).
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.
the effect of the baby's weight gain/decrease on 7,14, 21, 28 days
Time frame: The scale is sensitive enough to measure in very small units.
The baby's weight will be measured on days 7, 14, 21, 28, naked and without diapers.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
NURSAN ÇINAR, Prof principal investigator
Sakarya University
HAMİDE ZENGİN, Asis Prof principal investigator
Bilecik Seyh Edebali Universitesi
İBRAHİM CANER, Prof principal investigator
Sakarya University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coconut oil skin care group in people with Skin Care, run by Sakarya University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
effect on skin integrity (time frame: 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).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2023.