An interventional study of warm group/cold group in Pain, Acute and Premature, sponsored by Zekai Tahir Burak Women's Health Research and Education Hospital. Status unknown at 1 site in Turkey. Open to participants aged Up to 1 Month. Per ClinicalTrials.gov, last updated 2022-03-08.
Sponsored by Zekai Tahir Burak Women's Health Research and Education Hospital · Not applicable, Interventional, and Supportive care
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.
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.
1,073 studies on the registry are indexed under Acute Pain; 166 are open to participants now.
This study's planned enrollment of 30 is below the median of 86 across 902 interventional studies indexed under Acute Pain.
Browse Acute Pain studies →Zekai Tahir Burak Women's Health Research and Education Hospital is the lead sponsor of 62 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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
-
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.
Other: warm group/cold group
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.
sequential randomization
change feeling of pain and restlessness in premature
Evaluation of pain score in the patient during the procedure with n-pass evaluation
Time frame: every 10 seconds before the 5 minutes and during the procedure
protection of body temperature
body temperature monitoring before and during the incubator with skin temperature probe
Time frame: before 5 min, during procedure
Plan to share: No
No publications or documents are linked to this record.
Started May 2020 (actual). Primary completion is estimated for Sep 2022, 28 months after the start.
Of 424 non-industry interventional studies with no phase under Acute Pain, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 23. This study's planned 28 months is above that.
Counting every sponsor, half of 430 studies reached it within 11 months; a quarter within 5 and three quarters within 23.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Zekai Tahir Burak Women's Health Research and Education Hospital