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Clinical Trials/NCT04458441
NCT04458441UnknownNot Applicable

Does Warm Skin Disinfection Reduce the Pain Score or Increase the Application Success in Peripheral Central Catheter Application in Premature Babies?

Zekai Tahir Burak Women's Health Research and Education Hospital1 site in 1 country30 target enrollmentStarted: May 5, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
30
Locations
1
Primary Endpoint
change feeling of pain and restlessness in premature

Study Overview

Brief 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. 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

Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group
Primary Purpose
Supportive Care
Masking
Double (Care Provider, Investigator)

Eligibility Criteria

Ages
— to 1 Month (Child)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • protection of body temperature(before 5 min, during procedure)

Investigators

Sponsor
Zekai Tahir Burak Women's Health Research and Education Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Funda Yavanoglu Atay

principal investigator

Zekai Tahir Burak Women's Health Research and Education Hospital

Study Sites (1)

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