Neonatal Skin ConditionsNCT06246864
Evaluation of the Effects on the Skin of Different Materials Used in Orogastric Tube Detection in Premature Babies
A study testing Hydrocolloid dressing and Hypoallergenic Flexible in people with Neonatal Skin Conditions, run by Ondokuz Mayıs University.
Trial summary
While medical adhesives provide fixation of devices and catheters in neonatal intensive care, they can cause disruption of skin integrity when removed. Therefore, when detecting medical devices, it is important to choose products that will not harm babies' skin and to use different occlusive dressings (polymer foams… Read more about this study
- Who is it for?
- Ages 32 to 36 weeks
- Conditions the study is for
- Neonatal Skin Conditions
- What is being tested?
- Hydrocolloid dressing and Hypoallergenic Flexible
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 5 Feb 2024to 31 Dec 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
- No healthy volunteers
- Child
Who may be able to join
- A newborn is a baby born between 32-36 weeks of gestation
- No medical adhesive tape should be applied to the newborn's lips beforehand.
- The newborn does not have any skin diseases
- OG will be inserted into the newborn for the first time
- Having a newborn receiving respiratory support with non-invasive mechanical ventilation, hood or free oxygen
Who cannot join
- The newborn is not a baby born between 32-36 weeks of gestation
- Applying medical adhesive tape on the newborn's lips beforehand
- The newborn has any skin disease
- OG has been inserted into the newborn before and detected.
- Supporting and detecting the newborn's breathing by intubating it
Trial locations and contacts
No sites are listed yet.
About this study
While medical adhesives provide fixation of devices and catheters in neonatal intensive care, they can cause disruption of skin integrity when removed. Therefore, when detecting medical devices, it is important to choose products that will not harm babies' skin and to use different occlusive dressings (polymer foams, hydrogel dressings, hydrocolloid dressings).
This study aims to compare the effectiveness of different types of patches (Hydrocolloid dressing and Hypoallergenic Flexible Patch) used in the detection of oragastric catheter (OG) in preterm babies hospitalized in the neonatal intensive care unit in preventing skin damage.
Read the detailed description
Many interventions are applied to premature babies in neonatal intensive care units due to the developing technologies in recent years. Babies in neonatal intensive care need many devices to maintain their vital functions and monitor the treatment process. The medical adhesive materials to be selected are important in determining the medical devices used in neonatal intensive care units, especially premature babies.
This study aims to compare the effectiveness of different types of patches (Hydrocolloid dressing and Hypoallergenic Flexible Patch) used in the detection of oragastric catheter (OG) in preterm babies hospitalized in the neonatal intensive care unit in preventing skin damage.
- Conditions
- Neonatal Skin Conditions
- Being tested
- Hydrocolloid dressing, Hypoallergenic Flexible
- Keywords
- premature, skin care, Hydrocolloid dressing, hypoallergenic patch
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrocolloid dressingOther
After the oral gastric tube is placed on the premature baby and fixed with a Hydrocolloid dressing, the fixed patch will be removed after 24 hours using a silicone-based spray remover.
Hypoallergenic FlexibleOther
After the oral gastric tube is placed on the premature baby and fixed with a hypoallergenic flexible patch, the fixed patch will be removed after 24 hours using a silicone-based spray remover.
| Study group | Role | What they receive |
|---|---|---|
| Hydrocolloid dressing group | Experimental | The premature baby's Oragastric tube will be fixed using a hydrocollaid dressing. Orogastric fixation will not be changed for 24 days. After 24 hours, the fixed patch will be removed using a silicone-based spray remover. Receives: Other: Hydrocolloid dressing |
| Hypoallergenic Flexible Patch group | Active comparator | Oragastric tube of premature baby Hypoallergenic Flexible Patch will be detected using . Orogastric fixation will not be changed for 24 days. After 24 hours, the fixed patch will be removed using a silicone-based spray remover. Receives: Other: Hypoallergenic Flexible |
What is being measured
The primary outcome is the main question the study is designed to answer.
Newborn Skin Condition Score
NSCS allows evaluation of the newborn's skin condition. It evaluates skin dryness, redness and integrity, which are the basic characteristics of the newborn's skin. The scale consists of three parameters.
Measured: The patch will be removed 24 hours after orogastric detection and a skin evaluation will be performed immediately.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start5 Feb 2024 (estimated)
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 control experimental trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esra TURAL BUYUK, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06246864
- Sponsor's protocol ID
- Flaster
- Status last verified
- Feb 2024
- First submitted
- 30 Jan 2024
- Last updated
- 9 Feb 2024
- 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 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects on the Skin of Different Materials Used in Orogastric Tube Detection in Premature Babies
- ClinicalTrials.gov ID
- NCT06246864
- Acronym / sponsor ID
- Flaster
- Conditions
- Neonatal Skin Conditions
- Keywords
- premature, skin care, Hydrocolloid dressing, hypoallergenic patch
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 5 Feb 2024 (estimated)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 7 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, they can cause disruption of skin integrity when removed. Therefore, when detecting medical devices, it is important to choose products that will not harm babies' skin and to use different occlusive dressings (polymer foams, hydrogel dressings, hydrocolloid dressings).
This study aims to compare the effectiveness of different types of patches (Hydrocolloid dressing and Hypoallergenic Flexible Patch) used in the detection of oragastric catheter (OG) in preterm babies hospitalized in the neonatal intensive care unit in preventing skin damage.
Detailed description
Many interventions are applied to premature babies in neonatal intensive care units due to the developing technologies in recent years. Babies in neonatal intensive care need many devices to maintain their vital functions and monitor the treatment process. The medical adhesive materials to be selected are important in determining the medical devices used in neonatal intensive care units, especially premature babies.
This study aims to compare the effectiveness of different types of patches (Hydrocolloid dressing and Hypoallergenic Flexible Patch) used in the detection of oragastric catheter (OG) in preterm babies hospitalized 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 control experimental trial
| Arm | Type | Receives |
|---|---|---|
| Hydrocolloid dressing group | Experimental | Other: Hydrocolloid dressingThe premature baby's Oragastric tube will be fixed using a hydrocollaid dressing. Orogastric fixation will not be changed for 24 days. After 24 hours, the fixed patch will be removed using a silicone-based spray remover. |
| Hypoallergenic Flexible Patch group | Active comparator | Other: Hypoallergenic FlexibleOragastric tube of premature baby Hypoallergenic Flexible Patch will be detected using . Orogastric fixation will not be changed for 24 days. After 24 hours, the fixed patch will be removed using a silicone-based spray remover. |
Who may qualify
- Ages
- 32 to 36 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- A newborn is a baby born between 32-36 weeks of gestation
- No medical adhesive tape should be applied to the newborn's lips beforehand.
- The newborn does not have any skin diseases
- OG will be inserted into the newborn for the first time
- Having a newborn receiving respiratory support with non-invasive mechanical ventilation, hood or free oxygen
Key exclusion criteria (5 listed)
- The newborn is not a baby born between 32-36 weeks of gestation
- Applying medical adhesive tape on the newborn's lips beforehand
- The newborn has any skin disease
- OG has been inserted into the newborn before and detected.
- Supporting and detecting the newborn's breathing by intubating it
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 |
|---|---|---|
| Hydrocolloid dressingAfter the oral gastric tube is placed on the premature baby and fixed with a Hydrocolloid dressing, the fixed patch will be removed after 24 hours using a silicone-based spray remover. | Other | Hydrocolloid dressing group |
| Hypoallergenic FlexibleAfter the oral gastric tube is placed on the premature baby and fixed with a hypoallergenic flexible patch, the fixed patch will be removed after 24 hours using a silicone-based spray remover. | Other | Hypoallergenic Flexible Patch group |
Primary outcome
Newborn Skin Condition Score
Time frame: The patch will be removed 24 hours after orogastric detection and a skin evaluation will be performed immediately.
NSCS allows evaluation of the newborn's skin condition. It evaluates skin dryness, redness and integrity, which are the basic characteristics of the newborn's skin. The scale consists of three parameters.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Hydrocolloid dressing and Hypoallergenic Flexible in people with Neonatal Skin Conditions, run by Ondokuz Mayıs University.
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 5 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: status not confirmed, as of the sponsor's last update on 9 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Esra Tural Büyük, pHD (5052795196, esratural55@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Newborn Skin Condition Score (time frame: The patch will be removed 24 hours after orogastric detection and a skin evaluation will be performed immediately.). 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 9 Feb 2024.