Can Warm Skin Disinfection Reduce the Pain Peripheral Central Catheter Application in Premature Babies? (w-pi)

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.

Study Overview

• Status: Recruiting
• Conditions: Pain, Acute; Premature
• Intervention / Treatment: Other: warm group/cold group

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Recruiting
    • University of Health Sciences Istanbul Umraniye Teaching Hospital
    • Contact: funda atay

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 month (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: warm skin desenfection group; 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; sequential randomization
No Intervention: cold skin desenfection 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change feeling of pain and restlessness in premature	Evaluation of pain score in the patient during the procedure with n-pass evaluation	every 10 seconds before the 5 minutes and during the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
protection of body temperature	body temperature monitoring before and during the incubator with skin temperature probe	before 5 min, during procedure

Collaborators and Investigators

• Sponsor: Zekai Tahir Burak Women's Health Research and Education Hospital
• Collaborators: Umraniye Education and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2020
• Primary Completion (Anticipated): September 5, 2022
• Study Completion (Anticipated): December 30, 2022

Study Registration Dates

• First Submitted: July 1, 2020
• First Submitted That Met QC Criteria: July 1, 2020
• First Posted (Actual): July 7, 2020

Study Record Updates

• Last Update Posted (Actual): March 8, 2022
• Last Update Submitted That Met QC Criteria: March 6, 2022
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: premature, pain score, Picc line
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth; Acute Pain
• Other Study ID Numbers: 1001 (Registro Nacional Estudios Clinicos (RNEC))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No