ChildNCT07503457
The Effect of Using Coconut Oil and Moisturizing Lotion in Moisturizing the Skin of Premature Newborns
A study testing Oil Application and Moisturizing Lotion in people with Child, run by Bircan Kahraman Berberoglu at 1 site in Turkey (Türkiye).
Trial summary
Hypothesis H01: Using coconut oil and moisturizing lotion to moisturize the skin of preterm infants has no effect on skin condition assessment scores. Hypothesis H02: Using coconut oil and moisturizing lotion to moisturize the skin of preterm infants has no effect on pH values. Read more about this study
- Who is it for?
- Ages 32 to 37 weeks
- Conditions the study is for
- Child
- What is being tested?
- Oil Application and Moisturizing Lotion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Mar 2024to 16 Sep 2025
- 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 32 to 37 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Babies with a gestational age between 320/7 and 376/7 weeks,
- Babies with a birth weight of 1500 grams or more will be included.
- Exclusion Criteria: Infants who: • are receiving invasive or non-invasive mechanical ventilation support,
- are receiving oxygen support at a concentration greater than 23-25% in the incubator,
- have a major congenital anomaly on the skin surface,
- have a high infection or risk of infection due to surgery,
- have a congenital anomaly,
- have a skin disease/problem covering more than 5% of their body surface will not be included.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect Of Using Coconut Oil And Moisturizing Lotion In Moisturizing The Skin Of Premature Newborns On Skin Condition And Vital Signs
Hypothesis H01: Using coconut oil and moisturizing lotion to moisturize the skin of preterm infants has no effect on skin condition assessment scores.
Hypothesis H02: Using coconut oil and moisturizing lotion to moisturize the skin of preterm infants has no effect on pH values.
Read more
Hypothesis H03: Using coconut oil and moisturizing lotion to moisturize the skin of preterm infants has no effect on skin moisture levels.
Hypothesis H04: Using coconut oil and moisturizing lotion to moisturize the skin of preterm infants has no effect on body temperature values.
Hypothesis H05: Using coconut oil and moisturizing lotion to moisturize the skin of preterm infants has no effect on pulse values. Hypothesis H06: Using coconut oil and moisturizing lotion to moisturize the skin of preterm infants has no effect on saturation values.
Read the detailed description
This study is designed as a randomized controlled trial. The study will include three groups: two intervention groups and one control group. Infants meeting the inclusion criteria will be allocated to the groups using a simple randomization method. The study will be conducted between September 16, 2024, and March 16, 2025 (6 months) with 32-37-week premature infants admitted to the Intensive Care Unit of Democracy University Buca Seyfi Demirsoy Training and Research Hospital in Izmir.
There are three groups: Study Group 1 (moisturizing lotion [Muslera®]) (n=30), Study Group 2 (coconut oil) (n=30), and Control Group (n=30). In the intervention groups, moisturizing lotion or coconut oil will be applied to the infants' skin, whereas infants in the control group will receive routine skincare provided in the ward.
Portable devices will be used to measure skin pH (Ph-Meter 98218) and moisture (Elitech GSP-6 Dual-Cable Temperature and Humidity Measurement Data Logger). These devices measure skin moisture and pH through contact and have no harmful effects on the human body.
Kolmogorov-Smirnov or Shapiro-Wilk tests will be used to assess the normality of the data. Descriptive statistical analyses (number, percentage, mean, standard deviation, etc.), chi-square test, Student's t-test or Mann-Whitney U test for comparisons between two groups, and one-way analysis of variance (ANOVA) or Kruskal-Wallis H test for comparisons among three groups will be used. Pearson or Spearman correlation analyses will be conducted to evaluate the relationships between continuous variables (Büyüköztürk, 2017). A p-value of <0.05 will be considered statistically significant.
- Conditions
- Child
- Being tested
- Oil Application, Moisturizing Lotion
- Keywords
- moisturizing lotion, coconut oil, Preterm
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oil ApplicationBehavioural
- The researcher will wash their hands again according to the hospital's procedure.
- During the application, the baby will first be placed on its back, then on its side and stomach, and the body will be lubricated with coconut oil.
- Coconut oil will be applied to the entire body surface except the hands, head, face, and genital area with light touches using the palm of the hand. The application will take approximately 8-10 minutes. The amount of oil to be used in each application will be approximately 3-4 ml/kg.
Moisturizing LotionBehavioural
The researcher will wash their hands again according to the hospital's procedure.
During the application, the baby will first be placed on its back, then on its side and stomach, and the body will be lubricated with moisturizing lotion.
Moisturizing Lotion will be applied to the entire body surface except the hands, head, face, and genital area with light touches using the palm of the hand. The application will take approximately 8-10 minutes. The amount of oil to be used in each application will be approximately 3-4 ml/kg.
| Study group | Role | What they receive |
|---|---|---|
| Moisturizing Lotion | Experimental | * Intervention Group 1 (Moisturizing Lotion)
* The application and data collection will be carried out by Nurse Zehra SÖZKESEN, who works in the neonatal intensive care unit where the research will be conducted. The research will last 5 days for each baby. Measurements will be taken before and after the application (15 minutes after application).
* Before the application, the parent will be consulted and an "Informed Consent Form" will be completed.
* Applications will be performed in a way that does not disrupt the ward routine and will be carried out after daily care during routine care hours, between 09:00-10:00 in the morning.
* The lotion to be used for babies included in the moisturizing lotion group will be kept at the patient's bedside with a barcode label attached to each patient, and a separate sterile container of lotion will be used for each patient.
* Before the application, the researcher will wash their hands according to the hospital's procedur Receives: Behavioral: Moisturizing Lotion |
| Coconut Oil Group | Experimental | Intervention Group 2 (Coconut Oil Group)
* The application and data collection will be carried out by Nurse Zehra SÖZKESEN, who works in the neonatal intensive care unit where the research will be conducted. The research will last 5 days for each baby. Measurements will be taken before and after the application (15 minutes after the application).
* Before the application, the parent will be consulted and an "Informed Consent Form" will be completed.
* Applications will be performed in a way that does not disrupt the ward routine and will be carried out after daily care between 09:00-10:00 in the morning, which are routine care hours.
* The oil to be used for babies included in the coconut oil group will be kept at the patient's bedside with a barcode label attached to each patient and will be used in a separate sterile container for each patient.
* Before the application, the researcher will wash their hands according to the hospital's procedure. Receives: Behavioral: Oil Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infant Information and Monitoring Form (Appendix 1):
The Infant Information Form is an 8-question form prepared by researchers using literature. The form includes information on the baby's demographic characteristics, gender, gestational age at birth and corrected gestational age, mode of delivery, birth weight, head circumference, medical diagnosis, and feeding type. Additionally, a table is included at the bottom of the form for recording the baby's body temperature, heart rate, oxygen saturation, skin moisture, and skin pH before and for 5 days after the procedure.
Measured: five days
Neonatal Skin Status Assessment (Appendix 2):
This scale, developed by Lund and Osborne (2004), is used to assess the skin status of healthy or sick preterm, term, and postterm newborns. The newborn's skin status is scored based on the presence of redness, dryness, and impaired skin integrity/peeling. It is developed as a three-point Likert scale, with each item/finding given a score from 1 to 3. The lowest possible score is 3, and the highest is 9. A total score higher than 3 indicates a risk of impaired skin integrity in the newborn, while a higher score indicates poor skin status. The reliability of the scale has been reported by researchers to be between 0.66 and 0.89.
Measured: five days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2026
- Study start16 Mar 2024
- Primary completion16 Mar 2025
- Study completion16 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ChildStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bircan Kahraman Berberoglu
- Sponsor type
- University, hospital or other
- Collaborators
- Aydin Adnan Menderes University
- Responsible party
- Sponsor-investigator, Bircan Kahraman Berberoglu, Aydin Adnan Menderes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07503457
- Sponsor's protocol ID
- Aydın Adnan Menderes Uni
- Status last verified
- Apr 2026
- First submitted
- 26 Mar 2026
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Guner Basara S, Kahraman Berberoglu B, Calisir H, Sozkesen Z, Emirhan M, Sahin S. The effects of coconut oil and moisturising lotion on skin condition and vital signs in preterm neonates: A randomised controlled trial. J Pediatr Nurs. 2026 Oct 6:S0882-5963(26)00499-9. doi: 10.1016/j.pedn.2026.09.050. Online ahead of print.
PubMed 42838805
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Using Coconut Oil And Moisturizing Lotion In Moisturizing The Skin Of Premature Newborns On Skin Condition And Vital Signs
- ClinicalTrials.gov ID
- NCT07503457
- Acronym / sponsor ID
- Aydın Adnan Menderes Uni
- Conditions
- Child
- Keywords
- moisturizing lotion, coconut oil, Preterm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Bircan Kahraman BerberogluUniversity, hospital or other
- Collaborators
- Aydin Adnan Menderes University
- Study start
- 16 Mar 2024 (actual)
- Primary completion
- 16 Mar 2025 (actual)
- Study completion
- 16 Sep 2025 (actual)
- First posted
- 31 Mar 2026 (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.
Hypothesis H01: Using coconut oil and moisturizing lotion to moisturize the skin of preterm infants has no effect on skin condition assessment scores.
Hypothesis H02: Using coconut oil and moisturizing lotion to moisturize the skin of preterm infants has no effect on pH values.
Hypothesis H03: Using coconut oil and moisturizing lotion to moisturize the skin of preterm infants has no effect on skin moisture levels.
Hypothesis H04: Using coconut oil and moisturizing lotion to moisturize the skin of preterm infants has no effect on body temperature values.
Hypothesis H05: Using coconut oil and moisturizing lotion to moisturize the skin of preterm infants has no effect on pulse values. Hypothesis H06: Using coconut oil and moisturizing lotion to moisturize the skin of preterm infants has no effect on saturation values.
Detailed description
This study is designed as a randomized controlled trial. The study will include three groups: two intervention groups and one control group. Infants meeting the inclusion criteria will be allocated to the groups using a simple randomization method. The study will be conducted between September 16, 2024, and March 16, 2025 (6 months) with 32-37-week premature infants admitted to the Intensive Care Unit of Democracy University Buca Seyfi Demirsoy Training and Research Hospital in Izmir.
There are three groups: Study Group 1 (moisturizing lotion [Muslera®]) (n=30), Study Group 2 (coconut oil) (n=30), and Control Group (n=30). In the intervention groups, moisturizing lotion or coconut oil will be applied to the infants' skin, whereas infants in the control group will receive routine skincare provided in the ward.
Portable devices will be used to measure skin pH (Ph-Meter 98218) and moisture (Elitech GSP-6 Dual-Cable Temperature and Humidity Measurement Data Logger). These devices measure skin moisture and pH through contact and have no harmful effects on the human body.
Kolmogorov-Smirnov or Shapiro-Wilk tests will be used to assess the normality of the data. Descriptive statistical analyses (number, percentage, mean, standard deviation, etc.), chi-square test, Student's t-test or Mann-Whitney U test for comparisons between two groups, and one-way analysis of variance (ANOVA) or Kruskal-Wallis H test for comparisons among three groups will be used. Pearson or Spearman correlation analyses will be conducted to evaluate the relationships between continuous variables (Büyüköztürk, 2017). A p-value of <0.05 will be considered statistically significant.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moisturizing Lotion | Experimental | Behavioral: Moisturizing Lotion* Intervention Group 1 (Moisturizing Lotion) * The application and data collection will be carried out by Nurse Zehra SÖZKESEN, who works in the neonatal intensive care unit where the research will be conducted. The research will last 5 days for each baby. Measurements will be taken before and after the application (15 minutes after application). * Before the application, the parent will be consulted and an "Informed Consent Form" will be completed. * Applications will be performed in a way that does not disrupt the ward routine and will be carried out after daily care during routine care hours, between 09:00-10:00 in the morning. * The lotion to be used for babies included in the moisturizing lotion group will be kept at the patient's bedside with a barcode label attached to each patient, and a separate sterile container of lotion will be used for each patient. * Before the application, the researcher will wash their hands according to the hospital's procedur |
| Coconut Oil Group | Experimental | Behavioral: Oil ApplicationIntervention Group 2 (Coconut Oil Group) * The application and data collection will be carried out by Nurse Zehra SÖZKESEN, who works in the neonatal intensive care unit where the research will be conducted. The research will last 5 days for each baby. Measurements will be taken before and after the application (15 minutes after the application). * Before the application, the parent will be consulted and an "Informed Consent Form" will be completed. * Applications will be performed in a way that does not disrupt the ward routine and will be carried out after daily care between 09:00-10:00 in the morning, which are routine care hours. * The oil to be used for babies included in the coconut oil group will be kept at the patient's bedside with a barcode label attached to each patient and will be used in a separate sterile container for each patient. * Before the application, the researcher will wash their hands according to the hospital's procedure. |
Who may qualify
- Ages
- 32 to 37 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Babies with a gestational age between 320/7 and 376/7 weeks,
- Babies with a birth weight of 1500 grams or more will be included.
- Exclusion Criteria: Infants who: • are receiving invasive or non-invasive mechanical ventilation support,
- are receiving oxygen support at a concentration greater than 23-25% in the incubator,
- have a major congenital anomaly on the skin surface,
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Oil Application* The researcher will wash their hands again according to the hospital's procedure. * During the application, the baby will first be placed on its back, then on its side and stomach, and the body will be lubricated with coconut oil. * Coconut oil will be applied to the entire body surface except the hands, head, face, and genital area with light touches using the palm of the hand. The application will take approximately 8-10 minutes. The amount of oil to be used in each application will be approximately 3-4 ml/kg. | Behavioural | Coconut Oil Group |
| Moisturizing LotionThe researcher will wash their hands again according to the hospital's procedure. During the application, the baby will first be placed on its back, then on its side and stomach, and the body will be lubricated with moisturizing lotion. Moisturizing Lotion will be applied to the entire body surface except the hands, head, face, and genital area with light touches using the palm of the hand. The application will take approximately 8-10 minutes. The amount of oil to be used in each application will be approximately 3-4 ml/kg. | Behavioural | Moisturizing Lotion |
Primary outcome
Infant Information and Monitoring Form (Appendix 1):
Time frame: five days
The Infant Information Form is an 8-question form prepared by researchers using literature. The form includes information on the baby's demographic characteristics, gender, gestational age at birth and corrected gestational age, mode of delivery, birth weight, head circumference, medical diagnosis, and feeding type. Additionally, a table is included at the bottom of the form for recording the baby's body temperature, heart rate, oxygen saturation, skin moisture, and skin pH before and for 5 days after the procedure.
Neonatal Skin Status Assessment (Appendix 2):
Time frame: five days
This scale, developed by Lund and Osborne (2004), is used to assess the skin status of healthy or sick preterm, term, and postterm newborns. The newborn's skin status is scored based on the presence of redness, dryness, and impaired skin integrity/peeling. It is developed as a three-point Likert scale, with each item/finding given a score from 1 to 3. The lowest possible score is 3, and the highest is 9. A total score higher than 3 indicates a risk of impaired skin integrity in the newborn, while a higher score indicates poor skin status. The reliability of the scale has been reported by researchers to be between 0.66 and 0.89.
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 27 Apr 2026.
- Derived from this study: PubMed 42838805Guner Basara S, Kahraman Berberoglu B, Calisir H, Sozkesen Z, Emirhan M, Sahin S. The effects of coconut oil and moisturising lotion on skin condition and vital signs in preterm neonates: A randomised controlled trial. J Pediatr Nurs. 2026 Oct 6:S0882-5963(26)00499-9. doi: 10.1016/j.pedn.2026.09.050. Online ahead of print.
- Related InfoLink provided by the sponsor.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oil Application and Moisturizing Lotion in people with Child, run by Bircan Kahraman Berberoglu 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 8 inclusion and 0 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 27 Apr 2026. 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?
Infant Information and Monitoring Form (Appendix 1): (time frame: five days). 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?
On the ClinicalTrials.gov record for NCT07503457, which also lists 1 linked publication.
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 27 Apr 2026.