Neonatal Skin ConditionsNeonatesNCT05083234
Maintaining Skin Integrity in Neonates With Sunflower Seed Oil and Liquid Vaseline
A study testing Moisturizing with SSO and Moisturizing with LV in people with Neonatal Skin Conditions and Nursing Caries, run by Maltepe University at 1 site in Turkey (Türkiye).
Trial summary
In this randomized controlled study, 90 preterm and term neonates in the NICU of a state hospital were equally divided into 3 groups. The skin integrity of the newborns in all three groups was assessed in terms of the Neonatal Skin Condition Score (NSCS), which was performed a total of 9 times at 48-hour intervals. Read more about this study
- Who is it for?
- Ages 32 weeks and older
- Conditions the study is for
- Neonatal Skin Conditions, Nursing Caries
- What is being tested?
- Moisturizing with SSO and Moisturizing with LV
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2019to 25 Jun 2019
- 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 weeks and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Parents giving verbal and written consent,
- Hospitalized in the NICU within the first 24 hours after birth,
- With a birth weight of more than 1500 g,
- No life-threatening health problems and skin diseases.
Who cannot join
- Gestational age less than 32 weeks,
- Parents who do not give verbal and written permission,
- Hospitalized in the NICU after the first 24 hours after birth,
- With a birth weight of less than 1500 g,
- Having life-threatening health problems and skin diseases.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kanuni Sultan Süleyman Research and Training Hospital NICU
Istanbul, Küçükçekmece, 11349921
About this study
Official title: Maintaining Skin Integrity in Neonates With Sunflower Seed Oil and Liquid Vaseline: A Prospective Randomized Controlled Study
In this randomized controlled study, 90 preterm and term neonates in the NICU of a state hospital were equally divided into 3 groups. The skin integrity of the newborns in all three groups was assessed in terms of the Neonatal Skin Condition Score (NSCS), which was performed a total of 9 times at 48-hour intervals. The skin of the newborns in the first group was moisturized with SSO and with LV in the second group, once a day, a total of 17 times. Moisturizer was not applied to the skin of the third group of newborns (the control group).
Read the detailed description
Because the barrier function of the skin of the newborn is still immature, disruption of skin integrity is a commonly observed problem. The purpose of the study was to test the applicability and effectiveness of sunflower seed oil (SSO) and Liquid Vaseline (LV) in maintaining skin integrity in term and preterm neonates in the Neonatal Intensive Care Unit (NICU). The sample size of the study has been determined by the power analysis (G*Power 3.1.9.2), The sample size was found to be a total of 66 neonates including minimum of 22 neonates for each group. It was estimated that case losses may occur and therefore, it was decided to conduct the study with a total of 90 neonates including 30 neonates in three groups. Assignment of neonates to research groups was done according to the order of hospitalization in the NICU. The first hospitalized neonates SSO, the second hospitalized LV, and the third hospitalized were included in the control group. The groups were repeated until they were complete. Weighing the neonate, taking vital signs, evaluating the skin condition, wiping the whole body, and stabilizing the general condition of the neonate before moisturizing the skin were taken into account. Neonates Information Form(NIF) and Neonatal Skin Condition Score (NSCS) were used for data collection. Parents of neonates were informed about the study. First day of hospitalization; Demographic data and medical history of the neonate in the study or control group were obtained from the patient file records. The neonate was weighed, vital signs were taken, and the data were recorded in the NIF.
The body of all neonates in the research or control group was wiped on the 1st day of hospitalization. In the following days, it was repeated 2 times a week (Monday and Friday) in the same way.The skin condition of the neonate in the research or control group was evaluated with the NSCS scale. The first skin evaluation was performed on the 1st day of hospitalization (1st NSCS). Skin condition was re-evaluated at 48 hour intervals in the following days. Skin condition of the neonate in the control or research group was evaluated a total of 9 times with 48-hour intervals. After the initial skin condition assessment, the neonate's skin is moistened with SSO or LV, depending on the group. It was rehydrated once a day (24 hours apart) in the following days.
- Conditions
- Neonatal Skin Conditions, Nursing Caries
- Being tested
- Moisturizing with SSO, Moisturizing with LV, The control group was not moisturized.
- Keywords
- neonate, neonatal skin care, neonatal skin condition score, sunflower seed oil, liquid vaseline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moisturizing with SSOOther
Vital signs of newborns in the sunflower seed oil group were measured. The skin of newborns in the sunflower seed oil group was wiped without rubbing. The skin of newborns in the sunflower seed oil group was evaluated with the NSCS scale.
Moisturizing with LVOther
Vital signs of newborns in the liquid vaseline group were measured. The skin of newborns in the liquid vaseline group was wiped without rubbing. The skin of newborns in the liquid vaseline group was evaluated with the NSCS scale.
The control group was not moisturized.Other
Vital signs of newborns in the control group were measured. The skin of newborns in the control group was wiped without rubbing. The skin of newborns in the control group was evaluated with the NSCS scale.
| Study group | Role | What they receive |
|---|---|---|
| Sunflower Seed Oil Group (SSO) | Experimental | The skin of newborns in the sunflower seed oil group was moisturized with SSO Receives: Other: Moisturizing with SSO |
| Liquid Vaseline Group (LV) | Experimental | The skin of newborns in the liquid vaseline group was moisturized with LV. Receives: Other: Moisturizing with LV |
| Control Group | Experimental | The skin of newborns in the control group was not moisturized. Receives: Other: The control group was not moisturized. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin condition score of newborns
The NSCS was developed for clinical nurses to use to evaluate infant skin condition. The scale evaluates skin dryness, erythema, and eruption. The best and worst possible scores are 3 and 9, respectively. The scale does not have a cutoff value. High scores indicate poor skin condition, and low scores indicate normal skin condition
Measured: Change from skin condition score of newborns at 16 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2021
- Study start1 Apr 2019
- Primary completion20 Apr 2019
- Study completion25 Jun 2019
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 Neonatal Skin ConditionsStudies 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
- Parallel Assigment,
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maltepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Behice Ekici, Maltepe University
- Investigators
- Behice Ekici, PhD, Study director, Maltepe University School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05083234
- Sponsor's protocol ID
- 2017-10-01
- Acronym
- Neonates
- Status last verified
- Oct 2021
- First submitted
- 4 Oct 2021
- Last updated
- 19 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Karakoc IB, Ekici B. Maintaining Skin Integrity in Neonates with Sunflower Seed Oil and Liquid Vaseline: A Prospective Randomized Controlled Study. Adv Skin Wound Care. 2022 Dec 1;35(12):1-8. doi: 10.1097/01.ASW.0000891080.13305.75.
PubMed 36409190
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maintaining Skin Integrity in Neonates With Sunflower Seed Oil and Liquid Vaseline: A Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05083234
- Acronym / sponsor ID
- Neonates / 2017-10-01
- Conditions
- Neonatal Skin Conditions, Nursing Caries
- Keywords
- neonate, neonatal skin care, neonatal skin condition score, sunflower seed oil, liquid vaseline
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Maltepe UniversityUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 20 Apr 2019 (actual)
- Study completion
- 25 Jun 2019 (actual)
- First posted
- 19 Oct 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.
In this randomized controlled study, 90 preterm and term neonates in the NICU of a state hospital were equally divided into 3 groups. The skin integrity of the newborns in all three groups was assessed in terms of the Neonatal Skin Condition Score (NSCS), which was performed a total of 9 times at 48-hour intervals. The skin of the newborns in the first group was moisturized with SSO and with LV in the second group, once a day, a total of 17 times. Moisturizer was not applied to the skin of the third group of newborns (the control group).
Detailed description
Because the barrier function of the skin of the newborn is still immature, disruption of skin integrity is a commonly observed problem. The purpose of the study was to test the applicability and effectiveness of sunflower seed oil (SSO) and Liquid Vaseline (LV) in maintaining skin integrity in term and preterm neonates in the Neonatal Intensive Care Unit (NICU). The sample size of the study has been determined by the power analysis (G*Power 3.1.9.2), The sample size was found to be a total of 66 neonates including minimum of 22 neonates for each group. It was estimated that case losses may occur and therefore, it was decided to conduct the study with a total of 90 neonates including 30 neonates in three groups. Assignment of neonates to research groups was done according to the order of hospitalization in the NICU. The first hospitalized neonates SSO, the second hospitalized LV, and the third hospitalized were included in the control group. The groups were repeated until they were complete. Weighing the neonate, taking vital signs, evaluating the skin condition, wiping the whole body, and stabilizing the general condition of the neonate before moisturizing the skin were taken into account. Neonates Information Form(NIF) and Neonatal Skin Condition Score (NSCS) were used for data collection. Parents of neonates were informed about the study. First day of hospitalization; Demographic data and medical history of the neonate in the study or control group were obtained from the patient file records. The neonate was weighed, vital signs were taken, and the data were recorded in the NIF.
The body of all neonates in the research or control group was wiped on the 1st day of hospitalization. In the following days, it was repeated 2 times a week (Monday and Friday) in the same way.The skin condition of the neonate in the research or control group was evaluated with the NSCS scale. The first skin evaluation was performed on the 1st day of hospitalization (1st NSCS). Skin condition was re-evaluated at 48 hour intervals in the following days. Skin condition of the neonate in the control or research group was evaluated a total of 9 times with 48-hour intervals. After the initial skin condition assessment, the neonate's skin is moistened with SSO or LV, depending on the group. It was rehydrated once a day (24 hours apart) in the following days.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Parallel Assigment,
| Arm | Type | Receives |
|---|---|---|
| Sunflower Seed Oil Group (SSO) | Experimental | Other: Moisturizing with SSOThe skin of newborns in the sunflower seed oil group was moisturized with SSO |
| Liquid Vaseline Group (LV) | Experimental | Other: Moisturizing with LVThe skin of newborns in the liquid vaseline group was moisturized with LV. |
| Control Group | Experimental | Other: The control group was not moisturized.The skin of newborns in the control group was not moisturized. |
Who may qualify
- Ages
- 32 weeks and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Parents giving verbal and written consent,
- Hospitalized in the NICU within the first 24 hours after birth,
- With a birth weight of more than 1500 g,
- No life-threatening health problems and skin diseases.
Key exclusion criteria (5 listed)
- Gestational age less than 32 weeks,
- Parents who do not give verbal and written permission,
- Hospitalized in the NICU after the first 24 hours after birth,
- With a birth weight of less than 1500 g,
- Having life-threatening health problems and skin diseases.
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 |
|---|---|---|
| Moisturizing with SSOVital signs of newborns in the sunflower seed oil group were measured. The skin of newborns in the sunflower seed oil group was wiped without rubbing. The skin of newborns in the sunflower seed oil group was evaluated with the NSCS scale. | Other | Sunflower Seed Oil Group (SSO) |
| Moisturizing with LVVital signs of newborns in the liquid vaseline group were measured. The skin of newborns in the liquid vaseline group was wiped without rubbing. The skin of newborns in the liquid vaseline group was evaluated with the NSCS scale. | Other | Liquid Vaseline Group (LV) |
| The control group was not moisturized.Vital signs of newborns in the control group were measured. The skin of newborns in the control group was wiped without rubbing. The skin of newborns in the control group was evaluated with the NSCS scale. | Other | Control Group |
Primary outcome
Skin condition score of newborns
Time frame: Change from skin condition score of newborns at 16 days
The NSCS was developed for clinical nurses to use to evaluate infant skin condition. The scale evaluates skin dryness, erythema, and eruption. The best and worst possible scores are 3 and 9, respectively. The scale does not have a cutoff value. High scores indicate poor skin condition, and low scores indicate normal skin condition
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 19 Oct 2021.
- Derived from this study: PubMed 36409190Karakoc IB, Ekici B. Maintaining Skin Integrity in Neonates with Sunflower Seed Oil and Liquid Vaseline: A Prospective Randomized Controlled Study. Adv Skin Wound Care. 2022 Dec 1;35(12):1-8. doi: 10.1097/01.ASW.0000891080.13305.75.
- 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.
Behice Ekici, PhD study director
Maltepe University School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moisturizing with SSO and Moisturizing with LV in people with Neonatal Skin Conditions and Nursing Caries, run by Maltepe 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 19 Oct 2021. 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?
Skin condition score of newborns (time frame: Change from skin condition score of newborns at 16 days). 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 NCT05083234, 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 19 Oct 2021.