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Can Warm Skin Disinfection Reduce the Pain Peripheral Central Catheter Application in Premature Babies?

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04458441
Acronym
w-pi
Enrollment
30
Registered
2020-07-07
Start date
2020-05-05
Completion date
2022-12-30
Last updated
2022-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Acute, Premature

Keywords

premature, pain score, Picc line

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.

Interventions

OTHERwarm group/cold group

sequential randomization

Sponsors

Umraniye Education and Research Hospital
CollaboratorOTHER_GOV
Zekai Tahir Burak Women's Health Research and Education Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
No minimum to 1 Months
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 \-

Design outcomes

Primary

MeasureTime frameDescription
change feeling of pain and restlessness in prematureevery 10 seconds before the 5 minutes and during the procedureEvaluation of pain score in the patient during the procedure with n-pass evaluation

Secondary

MeasureTime frameDescription
protection of body temperaturebefore 5 min, during procedurebody temperature monitoring before and during the incubator with skin temperature probe

Countries

Turkey (Türkiye)

Contacts

Primary Contactfunda atay
funday.atay@gmail.com+905054409167

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026