Pain, Acutew-piNCT04458441
Can Warm Skin Disinfection Reduce the Pain Peripheral Central Catheter Application in Premature Babies?
A study testing warm group/cold group in people with Pain, Acute and Premature, run by Zekai Tahir Burak Women's Health Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
Peripheral central catheter application, especially in extremely low birth weight premature babies, is an intensive care follow-up procedure. There are many clinical studies in areas such as catheter type, skin disinfection, catheter duration, catheter infection. Read more about this study
- Who is it for?
- Ages Up to 1 month
- Conditions the study is for
- Pain, Acute, Premature
- What is being tested?
- warm group/cold group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 May 2020to 30 Dec 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 Up to 1 month
- All sexes
- No healthy volunteers
- Child
Inclusion Criteria: below 32 gestational weeks and / or 1250 grams preterm babies neonates requiring total parenteral nutrition, antibiotic therapy for at least 7 days, -
Exclusion Criteria: major congenital anomalilies refusal to sign consent patient with previously attemped or placed central lines
-
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
University of Health Sciences Istanbul Umraniye Teaching Hospital
Istanbul
funda atay
About this study
Official title: Does Warm Skin Disinfection Reduce the Pain Score or Increase the Application Success in Peripheral Central Catheter Application in Premature Babies?
Peripheral central catheter application, especially in extremely low birth weight premature babies, is an intensive care follow-up procedure. There are many clinical studies in areas such as catheter type, skin disinfection, catheter duration, catheter infection. In our practice, it was observed that premature baby was less uncomfortable, the number of trials decreased, and the change in body temperature was less with the application of hot skin disinfection in our practice. With a prospective randomized study, the investigators wanted to document their observational data scientifically.
Read the detailed description
Babies under 32 gestation week and 1250 g who are treated at level 3 NICU and need peripheral central catheter will be included in the study. In the preparation of peripheral central catheter application, skin cleaning is performed with povidone iodine in our clinic. The investigators used during the povidione iodine preparation phase after heating the bain-marie method with sterile conditions. The investigators predicted that the premature baby would have less discomfort with warm povidion iodine. To demonstrate this, it was planned to take both video recordings during the application and N-PASS evaluation by an experienced person who does not know the povidone iodine temperature used .In preparation of the catheter except the person who did povidone iodine skin cleansing, nobody knows the heat. The catheters were administered by a single experienced person. The study was designed to be unaware of the povidin iodine application temperature of the person applying the catheter and the N-PASS assessment.
- Conditions
- Pain, Acute, Premature
- Being tested
- warm group/cold group
- Keywords
- premature, pain score, Picc line
- Medical subject headings
- Acute Pain, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
warm group/cold groupOther
sequential randomization
| Study group | Role | What they receive |
|---|---|---|
| warm skin desenfection group | Active comparator | Povidion iodine will be used as a skin cleanser. povidion iodine will be heated sterile to 38 degrees with a ben-mari method and its temperature will be controlled by degrees. When it reaches the appropriate degree, the skin cleaning of the baby will be done sterile. Receives: Other: warm group/cold group |
| cold skin desenfection group | No intervention | Povidion iodine will be used as a skin cleanser. povidion iodine will be used in the skin cleaning of the baby without any heating procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
change feeling of pain and restlessness in premature
Evaluation of pain score in the patient during the procedure with n-pass evaluation
Measured: every 10 seconds before the 5 minutes and during the procedure
Secondary outcomes (1)
protection of body temperature
body temperature monitoring before and during the incubator with skin temperature probe
Measured: before 5 min, during procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start5 May 2020
- Primary completion5 Sep 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, AcuteStudies 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
- Single group
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zekai Tahir Burak Women's Health Research and Education Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Umraniye Education and Research Hospital
- Responsible party
- Principal investigator, Funda Yavanoglu Atay, Zekai Tahir Burak Women's Health Research and Education Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04458441
- Sponsor's protocol ID
- 1001
- Acronym
- w-pi
- Status last verified
- Jul 2021
- First submitted
- 1 Jul 2020
- Last updated
- 8 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Warm Skin Disinfection Reduce the Pain Score or Increase the Application Success in Peripheral Central Catheter Application in Premature Babies?
- ClinicalTrials.gov ID
- NCT04458441
- Acronym / sponsor ID
- w-pi / 1001
- Conditions
- Pain, Acute, Premature
- Keywords
- premature, pain score, Picc line
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Zekai Tahir Burak Women's Health Research and Education HospitalUniversity, hospital or other
- Collaborators
- Umraniye Education and Research Hospital
- Study start
- 5 May 2020 (actual)
- Primary completion
- 5 Sep 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 7 Jul 2020 (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.
Peripheral central catheter application, especially in extremely low birth weight premature babies, is an intensive care follow-up procedure. There are many clinical studies in areas such as catheter type, skin disinfection, catheter duration, catheter infection. In our practice, it was observed that premature baby was less uncomfortable, the number of trials decreased, and the change in body temperature was less with the application of hot skin disinfection in our practice. With a prospective randomized study, the investigators wanted to document their observational data scientifically.
Detailed description
Babies under 32 gestation week and 1250 g who are treated at level 3 NICU and need peripheral central catheter will be included in the study. In the preparation of peripheral central catheter application, skin cleaning is performed with povidone iodine in our clinic. The investigators used during the povidione iodine preparation phase after heating the bain-marie method with sterile conditions. The investigators predicted that the premature baby would have less discomfort with warm povidion iodine. To demonstrate this, it was planned to take both video recordings during the application and N-PASS evaluation by an experienced person who does not know the povidone iodine temperature used .In preparation of the catheter except the person who did povidone iodine skin cleansing, nobody knows the heat. The catheters were administered by a single experienced person. The study was designed to be unaware of the povidin iodine application temperature of the person applying the catheter and the N-PASS assessment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| warm skin desenfection group | Active comparator | Other: warm group/cold groupPovidion iodine will be used as a skin cleanser. povidion iodine will be heated sterile to 38 degrees with a ben-mari method and its temperature will be controlled by degrees. When it reaches the appropriate degree, the skin cleaning of the baby will be done sterile. |
| cold skin desenfection group | No intervention | –Povidion iodine will be used as a skin cleanser. povidion iodine will be used in the skin cleaning of the baby without any heating procedure. |
Who may qualify
- Ages
- Up to 1 month
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
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 |
|---|---|---|
| warm group/cold groupsequential randomization | Other | warm skin desenfection group |
Primary outcome
change feeling of pain and restlessness in premature
Time frame: every 10 seconds before the 5 minutes and during the procedure
Evaluation of pain score in the patient during the procedure with n-pass evaluation
1 secondary outcome
protection of body temperature
Time frame: before 5 min, during procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing warm group/cold group in people with Pain, Acute and Premature, run by Zekai Tahir Burak Women's Health Research and Education 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?
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 8 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?
Contact funda atay (+905054409167, funday.atay@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change feeling of pain and restlessness in premature (time frame: every 10 seconds before the 5 minutes and during the procedure). 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 8 Mar 2022.