Premature BirthDEAHNCT04972747
The Effect of Skin Care Applied With Two Different Oils on Skin Integrity and Growth Parameters in Premature Babies
A study testing skin care with sunflower oil in people with Premature Birth and Skin Care, run by Derince Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
As a result of technological advances in the field of newborns, the survival rates of very young babies have increased. With this situation, there was a need to develop new evidence-based application areas in premature babies. Read more about this study
- Who is it for?
- Ages 2 to 30 days
- Conditions the study is for
- Premature Birth, Skin Care
- What is being tested?
- skin care with sunflower oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Oct 2020to 30 Jul 2022
- 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 2 to 30 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Parents' agreement to participate in the research
- Preterm babies at 32-36 gestational week
- 1000 gr and above preterm babies
- Non-surgical infants are included.
Who cannot join
- Skin damage may occur over 5% of the body surface
- Preterm babies monitored on mechanical ventilation
- Preterm babies receiving phototherapy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Derince eğitim ve Araştırma Hastanesi
Kocaeli, İ̇zmi̇t, 41000
About this study
Official title: SBÜ Koceli Derince Eğitim ve Araştırma Hastanesi
As a result of technological advances in the field of newborns, the survival rates of very young babies have increased. With this situation, there was a need to develop new evidence-based application areas in premature babies. Nurses provide evidence-based care in many areas to term and preterm babies in the neonatal intensive care unit. One of these areas is the skin, which is known as 13% of the newborn's body weight and constitutes the largest part of the organism. Before skin care is given, knowing the skin characteristics of the newborn and performing skin care in accordance with these features will provide more benefits for the baby. The skin of newborns is different from adults in terms of both function and function. In addition, skin characteristics of term and preterm babies also differ according to the week of delivery.
Skin basically enables the newborn to explore the world by thermoregulation, as a barrier against microorganisms and chemical harmful substances, maintaining fluid-electrolyte balance, vitamin D production, fat storage and sensory-touch. The immature skin of the newborn cannot fully fulfill these functions. In another study conducted between sunflower oil and the control group, it was stated that rash and peeling were less common in the sunflower oil experiment group compared to the control group.
As a result, evidence-based knowledge of nurses about neonatal skin care should be increased in neonatal intensive care units, and appropriate nursing care should be given especially to premature newborns who are at risk due to hospitalization. Even if there is no routine procedure in our service, baby oil is massaged during care hours, but there is no study on this. The aim of this study is to contribute to the neonatal skin care literature and to provide appropriate evidence-based care in the service routine.
Read the detailed description
The research will be carried out with preterm babies hospitalized in the 3rd Level Neonatal Intensive Care Unit of SBÜ Kocaeli Derince Training and Research Hospital, Alikahya Campus and meeting the criteria of the study. Preterm babies with a birth weight of 1000 g and above, who do not receive ventilator support, and who do not have skin damage more than 5% of the body surface between 32-36 weeks of gestation will be included in the study. Two groups will be created by randomization method.
These groups are; Sunflower oil group: Babies to whom skin care will be applied with sunflower oil.
Coconut oil group: Babies who will be treated with coconut oil
After the premature babies who meet the study criteria are divided into groups and their consent is obtained, they will be followed up by the person conducting the study, and all applications will be carried out by the same person. Information about the newborn will be filled in by the person who will perform the application by using the "Form for Identifying the Introductory and Clinical Characteristics of the Newborn".
The application will be carried out twice a day during the maintenance hours of the service. In skin care applications, body baths are applied not more than three times a week, as it may cause hypothermia in preterm babies in the ward routine. In daily skin care, body cleaning with cotton, changing the fixation points such as orogastric probe, and changing the monitor probe locations are among the routine practices. In order to hydrate and moisturize the skin in preterm and term babies, baby oil in the service is used. Skin care applied in the service routine will be applied to the preterm babies included in the study, and only sunflower oil and coconut oil will be used as moisturizers.
APPLICATION Group 1: Preterm babies treated with sunflower oil
- 31 preterm babies determined by randomization method will be included in the group to be applied skin care with sunflower oil.
- Before the application, the researcher will meet with the family and fill in the "Informed Consent Form".
- Social hand washing will be applied before the application.
- Before the application, the skin of the newborn will be evaluated by using the "Neonatal Skin Condition Assessment Scale".
- In order to measure the moisture of the skin before the application, the moisture level of the skin will be recorded by measuring from three different points, namely the abdomen, legs and arms, with a DMM branded skin moisture meter.
- The baby will be placed under a radiant warmer by the practitioner to keep his body temperature.
- For the follow-up of growth parameters, the weight of the newborn will be weighed at the same time while the baby is naked, using the digital baby scale in the service. In addition, the baby's head circumference, height and belly circumference will be measured with a tape measure and recorded.
- Before each application, preterm babies will be given skin care in the service routine and sunflower oil will be applied twice a day for 14 days.
- Absorption of sunflower oil for preterm babies will be provided by using a baby massage application.
- Before the massage, 3-4 ml of sunflower oil will be applied to the whole body surface except the genital area and scalp.
- Massage to the baby will be started first on the legs and feet, then continued with massage of the abdomen and chest area, arms and hands, face and back, respectively, and will be applied for 15 minutes at least 30 minutes after feeding.
- 12 hours after each application, the skin of the newborn will be evaluated using the "Neonatal Skin Condition Assessment Scale", and the measurement will be made with a DMM brand skin moisture meter and recorded in the follow-up form.
- Weight monitoring will be recorded daily to monitor growth parameters and daily weight gain / decrease will be monitored. Head circumference and height lengths will be measured and recorded before the application and on the 7th and 14th day of the application.
Group 2: Preterm babies treated with coconut oil
- 31 preterm coconut oils determined by randomization method will be included in the group to be applied skin care.
- Before the application, the researcher will meet with the family and fill in the "Informed Consent Form".
- Social hand washing will be applied before the application.
- Before the application, the skin of the newborn will be evaluated by using the "Neonatal Skin Condition Assessment Scale".
- In order to measure the moisture of the skin before the application, the moisture level of the skin will be recorded by measuring from three different points, namely the abdomen, legs and arms, with a DMM branded skin moisture meter.
- The baby will be placed under a radiant warmer by the practitioner to keep his body temperature.
- For the follow-up of growth parameters, the weight of the newborn will be weighed at the same time while the baby is naked, using the digital baby scale in the service. In addition, the baby's head circumference, height and belly circumference will be measured with a tape measure and recorded.
- Before each application, preterm babies will be given skin care in the service routine and coconut oil will be applied twice a day for 14 days.
- Absorption of coconut oil for preterm babies will be provided by using a baby massage application.
- Before the massage, 3-4 ml of coconut oil will be applied to the whole body surface except the genital area and scalp.
- Massage to the baby will be started first on the legs and feet, then continued with massage of the abdomen and chest area, arms and hands, face and back, respectively, and will be applied for 15 minutes at least 30 minutes after feeding.
- 12 hours after each application, the skin of the newborn will be evaluated using the "Neonatal Skin Condition Assessment Scale", and the measurement will be made with a DMM brand skin moisture meter and recorded in the follow-up form.
- Weight monitoring will be recorded daily to monitor growth parameters and daily weight gain / decrease will be monitored. Head circumference and height lengths will be measured and recorded before the application and on the 7th and 14th day of the application.
Sunflower oil
Sunflower oil is a light yellow colored and light-tasting vegetable oil obtained from the seeds of the sunflower plant. It contains 90% unsaturated fatty acids (combined oleic and linoleic) and about 10% saturated fatty acids (palmitic and stearic). In the literature, the importance of using mineral oils in maintaining the integrity of the skin of newborns has been stated and there are many studies using sunflower oil on this subject.
Coconut Oil
Coconut oil is a highly saturated fat traditionally made from the oil's raw coconut or dried coconut kernels. Coconut oil is rich in medium-chain fatty acids, a saturated form of fat. It contains Lauric acid 49%, Mystic acid 18%, Caprylic acid 8%, Palmitic acid 8% and Capric acid 7%.
Recruitment Criteria;
- Parents' consent to participate in the research
- Preterm babies at 32-36 gestational week
- preterm babies with a weight of 1000 gr and above
- Non-surgical infants are included
Exclusion Criteria;
- Preterm babies monitored on mechanical ventilation
- Skin damage over 5% of the body surface
- Preterm babies receiving phototherapy
- Conditions
- Premature Birth, Skin Care
- Being tested
- skin care with sunflower oil
- Keywords
- skin care, preterm, coconut oil, sunflowers oil, growth parameter
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
skin care with sunflower oilOther
Also called skin care with coconut oil
The application will be carried out twice a day during the maintenance hours of the service. In skin care applications, body baths are applied not more than three times a week, as it may cause hypothermia in preterm babies in the ward routine. In daily skin care, body cleaning with cotton, changing the fixation points such as orogastric probe, and changing the monitor probe locations are among the routine practices. In order to hydrate and moisturize the skin in preterm and term babies, baby oil in the service is used. Skin care applied in the service routine will be applied to the preterm babies included in the study, and only sunflower oil and coconut oil will be used as moisturizers.
| Study group | Role | What they receive |
|---|---|---|
| Suggest skin care with sunflower oil for preterm babies | Experimental | * Before each application, preterm babies will be given skin care in the service routine and sunflower oil will be applied twice a day for 14 days.
* Absorption of sunflower oil for preterm babies will be provided by using a baby massage application.
* Before the massage, 3-4 ml of sunflower oil will be applied to the whole body surface except the genital area and scalp..
* 12 hours after each application, the skin of the newborn will be evaluated using the "Neonatal Skin Condition Assessment Scale" (Appendix-2), and the measurement will be made with a DMM brand skin moisture meter and recorded in the follow-up form. Receives: Other: skin care with sunflower oil |
| Suggest skin care with cocunut oil for preterm babies | Experimental | * Before each application, preterm babies will be given skin care in the service routine and coconut oil will be applied twice a day for 14 days.
* Absorption of coconut oil for preterm babies will be provided by using a baby massage application.
* Before the massage, 3-4 ml of coconut oil will be applied to the whole body surface except the genital area and scalp.
* 12 hours after each application, the skin of the newborn will be evaluated using the "Neonatal Skin Condition Assessment Scale" (Appendix-2), and the measurement will be made with a DMM brand skin moisture meter and recorded in the follow-up form. Receives: Other: skin care with sunflower oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of skin care applied with two different oils on skin integrity and growth parameters in premature babies
Neonatal Skin Condition Score-NSCS. The scale consists of three parameters. These; dryness, redness and deterioration of skin integrity/peeling. Each parameter is scored from one to three. The lowest score that can be obtained from the scale is 3, the highest score is 9, and a total score of 16 indicates that the skin condition of the newborn is poor.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study start16 Oct 2020
- Primary completion20 May 2021
- Study completion30 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature BirthStudies 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
- Model description
- randomized controlled clinical trial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Derince Training and Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Okan University
- Responsible party
- Principal investigator, Yaprak Tokdemir, Derince Training and Research Hospital
- Investigators
- Gülzade Uysal, assoc. prof, Principal investigator, Okan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04972747
- Sponsor's protocol ID
- 2020/124-2
- Acronym
- DEAH
- Status last verified
- Mar 2022
- First submitted
- 20 May 2021
- Last updated
- 22 Mar 2022
- 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 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SBÜ Koceli Derince Eğitim ve Araştırma Hastanesi
- ClinicalTrials.gov ID
- NCT04972747
- Acronym / sponsor ID
- DEAH / 2020/124-2
- Conditions
- Premature Birth, Skin Care
- Keywords
- skin care, preterm, coconut oil, sunflowers oil, growth parameter
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Derince Training and Research HospitalUniversity, hospital or other
- Collaborators
- Okan University
- Study start
- 16 Oct 2020 (actual)
- Primary completion
- 20 May 2021 (actual)
- Study completion
- 30 Jul 2022 (estimated)
- First posted
- 22 Jul 2021 (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.
As a result of technological advances in the field of newborns, the survival rates of very young babies have increased. With this situation, there was a need to develop new evidence-based application areas in premature babies. Nurses provide evidence-based care in many areas to term and preterm babies in the neonatal intensive care unit. One of these areas is the skin, which is known as 13% of the newborn's body weight and constitutes the largest part of the organism. Before skin care is given, knowing the skin characteristics of the newborn and performing skin care in accordance with these features will provide more benefits for the baby. The skin of newborns is different from adults in terms of both function and function. In addition, skin characteristics of term and preterm babies also differ according to the week of delivery.
Skin basically enables the newborn to explore the world by thermoregulation, as a barrier against microorganisms and chemical harmful substances, maintaining fluid-electrolyte balance, vitamin D production, fat storage and sensory-touch. The immature skin of the newborn cannot fully fulfill these functions. In another study conducted between sunflower oil and the control group, it was stated that rash and peeling were less common in the sunflower oil experiment group compared to the control group.
As a result, evidence-based knowledge of nurses about neonatal skin care should be increased in neonatal intensive care units, and appropriate nursing care should be given especially to premature newborns who are at risk due to hospitalization. Even if there is no routine procedure in our service, baby oil is massaged during care hours, but there is no study on this. The aim of this study is to contribute to the neonatal skin care literature and to provide appropriate evidence-based care in the service routine.
Detailed description
The research will be carried out with preterm babies hospitalized in the 3rd Level Neonatal Intensive Care Unit of SBÜ Kocaeli Derince Training and Research Hospital, Alikahya Campus and meeting the criteria of the study. Preterm babies with a birth weight of 1000 g and above, who do not receive ventilator support, and who do not have skin damage more than 5% of the body surface between 32-36 weeks of gestation will be included in the study. Two groups will be created by randomization method.
These groups are; Sunflower oil group: Babies to whom skin care will be applied with sunflower oil.
Coconut oil group: Babies who will be treated with coconut oil
After the premature babies who meet the study criteria are divided into groups and their consent is obtained, they will be followed up by the person conducting the study, and all applications will be carried out by the same person. Information about the newborn will be filled in by the person who will perform the application by using the "Form for Identifying the Introductory and Clinical Characteristics of the Newborn".
The application will be carried out twice a day during the maintenance hours of the service. In skin care applications, body baths are applied not more than three times a week, as it may cause hypothermia in preterm babies in the ward routine. In daily skin care, body cleaning with cotton, changing the fixation points such as orogastric probe, and changing the monitor probe locations are among the routine practices. In order to hydrate and moisturize the skin in preterm and term babies, baby oil in the service is used. Skin care applied in the service routine will be applied to the preterm babies included in the study, and only sunflower oil and coconut oil will be used as moisturizers.
APPLICATION Group 1: Preterm babies treated with sunflower oil
- 31 preterm babies determined by randomization method will be included in the group to be applied skin care with sunflower oil.
- Before the application, the researcher will meet with the family and fill in the "Informed Consent Form".
- Social hand washing will be applied before the application.
- Before the application, the skin of the newborn will be evaluated by using the "Neonatal Skin Condition Assessment Scale".
- In order to measure the moisture of the skin before the application, the moisture level of the skin will be recorded by measuring from three different points, namely the abdomen, legs and arms, with a DMM branded skin moisture meter.
- The baby will be placed under a radiant warmer by the practitioner to keep his body temperature.
- For the follow-up of growth parameters, the weight of the newborn will be weighed at the same time while the baby is naked, using the digital baby scale in the service. In addition, the baby's head circumference, height and belly circumference will be measured with a tape measure and recorded.
- Before each application, preterm babies will be given skin care in the service routine and sunflower oil will be applied twice a day for 14 days.
- Absorption of sunflower oil for preterm babies will be provided by using a baby massage application.
- Before the massage, 3-4 ml of sunflower oil will be applied to the whole body surface except the genital area and scalp.
- Massage to the baby will be started first on the legs and feet, then continued with massage of the abdomen and chest area, arms and hands, face and back, respectively, and will be applied for 15 minutes at least 30 minutes after feeding.
- 12 hours after each application, the skin of the newborn will be evaluated using the "Neonatal Skin Condition Assessment Scale", and the measurement will be made with a DMM brand skin moisture meter and recorded in the follow-up form.
- Weight monitoring will be recorded daily to monitor growth parameters and daily weight gain / decrease will be monitored. Head circumference and height lengths will be measured and recorded before the application and on the 7th and 14th day of the application.
Group 2: Preterm babies treated with coconut oil
- 31 preterm coconut oils determined by randomization method will be included in the group to be applied skin care.
- Before the application, the researcher will meet with the family and fill in the "Informed Consent Form".
- Social hand washing will be applied before the application.
- Before the application, the skin of the newborn will be evaluated by using the "Neonatal Skin Condition Assessment Scale".
- In order to measure the moisture of the skin before the application, the moisture level of the skin will be recorded by measuring from three different points, namely the abdomen, legs and arms, with a DMM branded skin moisture meter.
- The baby will be placed under a radiant warmer by the practitioner to keep his body temperature.
- For the follow-up of growth parameters, the weight of the newborn will be weighed at the same time while the baby is naked, using the digital baby scale in the service. In addition, the baby's head circumference, height and belly circumference will be measured with a tape measure and recorded.
- Before each application, preterm babies will be given skin care in the service routine and coconut oil will be applied twice a day for 14 days.
- Absorption of coconut oil for preterm babies will be provided by using a baby massage application.
- Before the massage, 3-4 ml of coconut oil will be applied to the whole body surface except the genital area and scalp.
- Massage to the baby will be started first on the legs and feet, then continued with massage of the abdomen and chest area, arms and hands, face and back, respectively, and will be applied for 15 minutes at least 30 minutes after feeding.
- 12 hours after each application, the skin of the newborn will be evaluated using the "Neonatal Skin Condition Assessment Scale", and the measurement will be made with a DMM brand skin moisture meter and recorded in the follow-up form.
- Weight monitoring will be recorded daily to monitor growth parameters and daily weight gain / decrease will be monitored. Head circumference and height lengths will be measured and recorded before the application and on the 7th and 14th day of the application.
Sunflower oil
Sunflower oil is a light yellow colored and light-tasting vegetable oil obtained from the seeds of the sunflower plant. It contains 90% unsaturated fatty acids (combined oleic and linoleic) and about 10% saturated fatty acids (palmitic and stearic). In the literature, the importance of using mineral oils in maintaining the integrity of the skin of newborns has been stated and there are many studies using sunflower oil on this subject.
Coconut Oil
Coconut oil is a highly saturated fat traditionally made from the oil's raw coconut or dried coconut kernels. Coconut oil is rich in medium-chain fatty acids, a saturated form of fat. It contains Lauric acid 49%, Mystic acid 18%, Caprylic acid 8%, Palmitic acid 8% and Capric acid 7%.
Recruitment Criteria;
- Parents' consent to participate in the research
- Preterm babies at 32-36 gestational week
- preterm babies with a weight of 1000 gr and above
- Non-surgical infants are included
Exclusion Criteria;
- Preterm babies monitored on mechanical ventilation
- Skin damage over 5% of the body surface
- Preterm babies receiving phototherapy
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Suggest skin care with sunflower oil for preterm babies | Experimental | Other: skin care with sunflower oil* Before each application, preterm babies will be given skin care in the service routine and sunflower oil will be applied twice a day for 14 days. * Absorption of sunflower oil for preterm babies will be provided by using a baby massage application. * Before the massage, 3-4 ml of sunflower oil will be applied to the whole body surface except the genital area and scalp.. * 12 hours after each application, the skin of the newborn will be evaluated using the "Neonatal Skin Condition Assessment Scale" (Appendix-2), and the measurement will be made with a DMM brand skin moisture meter and recorded in the follow-up form. |
| Suggest skin care with cocunut oil for preterm babies | Experimental | Other: skin care with sunflower oil* Before each application, preterm babies will be given skin care in the service routine and coconut oil will be applied twice a day for 14 days. * Absorption of coconut oil for preterm babies will be provided by using a baby massage application. * Before the massage, 3-4 ml of coconut oil will be applied to the whole body surface except the genital area and scalp. * 12 hours after each application, the skin of the newborn will be evaluated using the "Neonatal Skin Condition Assessment Scale" (Appendix-2), and the measurement will be made with a DMM brand skin moisture meter and recorded in the follow-up form. |
Who may qualify
- Ages
- 2 to 30 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Parents' agreement to participate in the research
- Preterm babies at 32-36 gestational week
- 1000 gr and above preterm babies
- Non-surgical infants are included.
Key exclusion criteria (3 listed)
- Skin damage may occur over 5% of the body surface
- Preterm babies monitored on mechanical ventilation
- Preterm babies receiving phototherapy
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 |
|---|---|---|
| skin care with sunflower oilAlso: skin care with coconut oilThe application will be carried out twice a day during the maintenance hours of the service. In skin care applications, body baths are applied not more than three times a week, as it may cause hypothermia in preterm babies in the ward routine. In daily skin care, body cleaning with cotton, changing the fixation points such as orogastric probe, and changing the monitor probe locations are among the routine practices. In order to hydrate and moisturize the skin in preterm and term babies, baby oil in the service is used. Skin care applied in the service routine will be applied to the preterm babies included in the study, and only sunflower oil and coconut oil will be used as moisturizers. | Other | Suggest skin care with cocunut oil for preterm babies, Suggest skin care with sunflower oil for preterm babies |
Primary outcome
The effect of skin care applied with two different oils on skin integrity and growth parameters in premature babies
Time frame: one year
Neonatal Skin Condition Score-NSCS. The scale consists of three parameters. These; dryness, redness and deterioration of skin integrity/peeling. Each parameter is scored from one to three. The lowest score that can be obtained from the scale is 3, the highest score is 9, and a total score of 16 indicates that the skin condition of the newborn is poor.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2022.
- 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.
Gülzade Uysal, assoc. prof principal investigator
Okan 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 skin care with sunflower oil in people with Premature Birth and Skin Care, run by Derince Training and Research Hospital 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 3 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: status not confirmed, as of the sponsor's last update on 22 Mar 2022. 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?
Results are not available in the source record.
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?
The effect of skin care applied with two different oils on skin integrity and growth parameters in premature babies (time frame: one year). 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 22 Mar 2022.