Neonatal Skin ConditionsNCT06280326
Effect of Different Materials Used in Orogastric Tube Removal on Skin Condition in Premature Babies
A study testing Sunflower oil and Slicone based spray in people with Neonatal Skin Conditions, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
While medical adhesives provide fixation of devices and catheters in neonatal intensive care, problems such as disruption of skin integrity are frequently encountered when removed. Read more about this study
- Who is it for?
- Ages 32 to 36 weeksHealthy volunteers can take part
- Conditions the study is for
- Neonatal Skin Conditions
- What is being tested?
- Sunflower oil and Slicone based spray
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Feb 2024to 5 Aug 2024
- 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 36 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Babies born between 32-36 gestational ages
- Babies admitted to Neonatal Intensive Care
- Babies who have not had medical adhesive tape applied to their lips before
- Babies who do not have any skin diseases
- Noninvasive Mechanical Ventilation or Free Ventilation in the Intensive Care Unit
- Babies who need oxygen
- Babies who do not have any obstacle to inserting an oragastric catheter
Who cannot join
- Babies followed intubated in care
- Babies with any skin disease
- Babies with a disease that is not suitable for oragastric catheter insertion
- Babies for whom medical adhesive should not be applied on the lips
Trial locations and contacts
1 site in 1 country.
About this study
While medical adhesives provide fixation of devices and catheters in neonatal intensive care, problems such as disruption of skin integrity are frequently encountered when removed. The study aims to compare the effectiveness of sunflower oil and silicone-based remover spray used during the removal of medical adhesives used in oragastric catheter fixation in preterm babies in the Neonatal Intensive Care Unit in preventing skin damage.
Read the detailed description
Use of materials such as an endotracheal tube, orogastric catheter, nasal cannula, and peripheral vein catheter, which are frequently used in neonatal intensive care.
Medical adhesives are needed for fixing. While medical adhesives provide fixation of devices and catheters in neonatal intensive care, problems such as disruption of skin integrity are frequently encountered when removed. Many materials are being tested and developed in clinics to reduce this risk.Skin barrier products minimize trauma in the removal of medical adhesives by creating a protective layer between the epidermis and the adhesive.
Silicone-based spray removers, one of the skin barrier products, are used in the entire patient population, including newborns.Silicone-based spray removers leave residue on the skin as they evaporate easily. doesn't let go. Since it does not contain alcohol, it does not cause pain. Sunflower oil is a traditional method for premature When used in baby massage applied to babies, it increases the weight gain and height growth of babies and reduces the morbidity rate.The study aims to compare the effectiveness of sunflower oil and silicone-based remover spray used during the removal of medical adhesives used in oragastric catheter fixation in preterm babies in the Neonatal Intensive Care Unit in preventing skin damage.
- Conditions
- Neonatal Skin Conditions
- Being tested
- Sunflower oil, Slicone based spray
- Keywords
- neonatal, skin care, sunflower, preterm, slicone based spray
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sunflower oilOther
In the experimental group, patch removal will be performed using sunflower oil.
Slicone based sprayOther
In the control group, clinical routine procedure will be used to remove the patch (silicone based spray.
| Study group | Role | What they receive |
|---|---|---|
| Sunflower Oil Group | Experimental | In the experimental group, patch removal will be performed using sunflower oil instead of silicone-based spray remover, which is the routine of the clinic. In children in the experimental group, the patch that has stuck to the baby's skin and needs to be changed is planned to be removed by applying sunflower oil on the patch. Receives: Other: Sunflower oil |
| Control group | Active comparator | In the clinic, the orogastric catheter is fixed above the lip (mustache area) with a hypoallergenic patch. In cases where the oral gastric catheter needs to be replaced or the adhesive patch needs to be renewed, hypoallergenic patches attached to the skin may cause tape abrasions and scratches on the newborn's skin when removed.Silicone-based spray removers are used to avoid causing injuries.
In the control group in the study, a silicone-based spray remover was used, which is the routine of the clinic, during the removal of hypoallergenic patches attached to the lip (moustache area) to fix the oragastric catheter. Receives: Other: Slicone based spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal Skin Condition Score
It is used to evaluate the skin condition of premature, healthy or sick newborns. The scale consists of three parts, each section has an evaluation section. These sections are respectively; dryness, erythema and disruption of skin integrity/peeling. Each section is scored between 1 and 3 on the scale developed as a three-point Likert scale.
is taking. The lowest score at the end of the scale is 3 and the highest score is 9. The higher the score, the worse the skin condition.
Measured: immediately after removing the patch of the orogastric tube and 1 hours later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start5 Feb 2024
- Primary completion5 Jun 2024 (estimated)
- Study completion5 Aug 2024 (estimated)
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.
- More trials run by Ondokuz Mayıs 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 experimental trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hatice Uzşen, Ondokuz Mayıs University
- Investigators
- Esra Tural Büyük, PhD, Study chair, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06280326
- Sponsor's protocol ID
- Orogastric Tube Removal
- Status last verified
- Feb 2024
- First submitted
- 30 Jan 2024
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sahin B, Buyuk ET, Uzsen H, Koyun M, Karal FI. Effect of different materials used in the removal of orogastric catheter adhesive on the skin in premature babies in Turkey. J Pediatr Nurs. 2024 Sep-Oct;78:e117-e123. doi: 10.1016/j.pedn.2024.06.026. Epub 2024 Jul 8.
PubMed 38971633
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Materials Used in Orogastric Tube Removal on Skin Condition in Premature Babies
- ClinicalTrials.gov ID
- NCT06280326
- Acronym / sponsor ID
- Orogastric Tube Removal
- Conditions
- Neonatal Skin Conditions
- Keywords
- neonatal, skin care, sunflower, preterm, slicone based spray
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 5 Feb 2024 (actual)
- Primary completion
- 5 Jun 2024 (estimated)
- Study completion
- 5 Aug 2024 (estimated)
- First posted
- 28 Feb 2024 (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.
While medical adhesives provide fixation of devices and catheters in neonatal intensive care, problems such as disruption of skin integrity are frequently encountered when removed. The study aims to compare the effectiveness of sunflower oil and silicone-based remover spray used during the removal of medical adhesives used in oragastric catheter fixation in preterm babies in the Neonatal Intensive Care Unit in preventing skin damage.
Detailed description
Use of materials such as an endotracheal tube, orogastric catheter, nasal cannula, and peripheral vein catheter, which are frequently used in neonatal intensive care.
Medical adhesives are needed for fixing. While medical adhesives provide fixation of devices and catheters in neonatal intensive care, problems such as disruption of skin integrity are frequently encountered when removed. Many materials are being tested and developed in clinics to reduce this risk.Skin barrier products minimize trauma in the removal of medical adhesives by creating a protective layer between the epidermis and the adhesive.
Silicone-based spray removers, one of the skin barrier products, are used in the entire patient population, including newborns.Silicone-based spray removers leave residue on the skin as they evaporate easily. doesn't let go. Since it does not contain alcohol, it does not cause pain. Sunflower oil is a traditional method for premature When used in baby massage applied to babies, it increases the weight gain and height growth of babies and reduces the morbidity rate.The study aims to compare the effectiveness of sunflower oil and silicone-based remover spray used during the removal of medical adhesives used in oragastric catheter fixation in preterm babies in the Neonatal Intensive Care Unit in preventing skin damage.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized controlled experimental trial
| Arm | Type | Receives |
|---|---|---|
| Sunflower Oil Group | Experimental | Other: Sunflower oilIn the experimental group, patch removal will be performed using sunflower oil instead of silicone-based spray remover, which is the routine of the clinic. In children in the experimental group, the patch that has stuck to the baby's skin and needs to be changed is planned to be removed by applying sunflower oil on the patch. |
| Control group | Active comparator | Other: Slicone based sprayIn the clinic, the orogastric catheter is fixed above the lip (mustache area) with a hypoallergenic patch. In cases where the oral gastric catheter needs to be replaced or the adhesive patch needs to be renewed, hypoallergenic patches attached to the skin may cause tape abrasions and scratches on the newborn's skin when removed.Silicone-based spray removers are used to avoid causing injuries. In the control group in the study, a silicone-based spray remover was used, which is the routine of the clinic, during the removal of hypoallergenic patches attached to the lip (moustache area) to fix the oragastric catheter. |
Who may qualify
- Ages
- 32 to 36 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Babies born between 32-36 gestational ages
- Babies admitted to Neonatal Intensive Care
- Babies who have not had medical adhesive tape applied to their lips before
- Babies who do not have any skin diseases
- Noninvasive Mechanical Ventilation or Free Ventilation in the Intensive Care Unit
Key exclusion criteria (4 listed)
- Babies followed intubated in care
- Babies with any skin disease
- Babies with a disease that is not suitable for oragastric catheter insertion
- Babies for whom medical adhesive should not be applied on the lips
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 |
|---|---|---|
| Sunflower oilIn the experimental group, patch removal will be performed using sunflower oil. | Other | Sunflower Oil Group |
| Slicone based sprayIn the control group, clinical routine procedure will be used to remove the patch (silicone based spray. | Other | Control group |
Primary outcome
Neonatal Skin Condition Score
Time frame: immediately after removing the patch of the orogastric tube and 1 hours later.
It is used to evaluate the skin condition of premature, healthy or sick newborns. The scale consists of three parts, each section has an evaluation section. These sections are respectively; dryness, erythema and disruption of skin integrity/peeling. Each section is scored between 1 and 3 on the scale developed as a three-point Likert scale. is taking. The lowest score at the end of the scale is 3 and the highest score is 9. The higher the score, the worse the skin condition.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Derived from this study: PubMed 38971633Sahin B, Buyuk ET, Uzsen H, Koyun M, Karal FI. Effect of different materials used in the removal of orogastric catheter adhesive on the skin in premature babies in Turkey. J Pediatr Nurs. 2024 Sep-Oct;78:e117-e123. doi: 10.1016/j.pedn.2024.06.026. Epub 2024 Jul 8.
- 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.
Esra Tural Büyük, PhD study chair
Ondokuz Mayıs 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 Sunflower oil and Slicone based spray in people with Neonatal Skin Conditions, run by Ondokuz Mayıs 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 7 inclusion and 4 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 28 Feb 2024. 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?
Neonatal Skin Condition Score (time frame: immediately after removing the patch of the orogastric tube and 1 hours later.). 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 NCT06280326, 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 28 Feb 2024.