The Effect of Implementation of Bundle for Preventing Blood Culture Contamination in Neonatal Intensive Care Unit

NCT06637696 | Completed

• 1 other identifier: BU-OK-01
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, investigators aimed to evaluate the impact of blood culture bundles on the incidence of contamination in the neonatal intensive care unit (NICU).

Conditions

Newborn; Infection

Keywords

blood culture bundle; blood culture contamination; cost-effectiveness; neonatal intensive care unit; neonates

Outcome Measures

Primary Outcomes (1)

• Blood Culture Contamination Rate

  The primary purpose of this study is to compare the contamination rate of blood culture taken with the bundle method and the contamination rate of blood culture taken with the standard method.

  1 year

Study Arms (2)

Blood Culture Bundle Group

ACTIVE COMPARATOR

In this group, blood culture collection was performed using a checklist other than the standard criteria.The checklist for the blood culture contamination precaution package (Table 1) was prepared using guidelines from the Turkish Society of Clinical Microbiology.

Other: Blood Culture Bundle

Control Blood Culture Group

PLACEBO COMPARATOR

In this group the standard practice in both periods was aseptic, non-contact technique for blood culture collection. For this purpose, hands were cleaned with antibacterial liquid soap (Klorhexin scrub antibacterial liquid soap 4-% Ekin Medical), the patient's skin was cleaned with povidone iodine 10% solution (Betadix 10% solution- Natural Medical Pharma) using sterile gloves, waited at least 30 seconds and then povidone iodine was removed from the skin with 70% alcohol.

Other: Blood Culture Bundle

Interventions

Blood Culture Bundle OTHER

In this pre and post intervention study investigators aimed to evaluate the impact of a blood culture bundles on the incidence of blood culture contamination rates in NICU.

Blood Culture Bundle Group; Control Blood Culture Group

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Newborns diagnosed with sepsis

You may not qualify if:

• Newborns receiving antibiotic treatment

Sponsors & Collaborators

• Dr. Behcet Uz Children's Hospital: lead

Study Sites (1)

Dr. Behcet Uz Children's Hospital

Izmir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Infections

Study Officials

• Oğuz Han Kalkanlı

  Dr. Behcet Uz Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Model Details: The study included a total of 320 (160 neonates in pre-bundle period, 160 neonates in post-bundle period) neonates.

Study Record Dates

• First Submitted: October 1, 2024
• First Posted: October 15, 2024
• Study Start: May 1, 2022
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2023
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)