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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06637696

Enrollment

320

Registered

2024-10-15

Start date

2022-05-01

Completion date

2023-05-31

Last updated

2024-10-15

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

Conditions

Newborn; Infection

Keywords

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

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).

Detailed description

Infections are never as frequent and life-threatening as in the neonatal period. The lack of sepsis-specific findings in the neonatal period, the narrow repertoire of clinical findings in newborns, and the fact that non-infectious clinical conditions frequently encountered in this period have similar findings pose a serious problem for early diagnosis and treatment of neonatal sepsis. Another important problem is that early empirical antibiotic treatment without diagnostic confirmation has to be resorted to very frequently in order to avoid morbidity and more importantly mortality with early intervention. This leads to unnecessary and prolonged treatment of newborns with potentially dangerous broad-spectrum antibiotics as well as prolonged hospitalizations and significant costs. The rate of contaminated blood culture in the neonatal period is 2.6-18%. 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).

Interventions

OTHERBlood Culture Bundle

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.

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Subject)

Intervention model description

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

Eligibility

Sex/Gender

ALL

Age

1 Days to 28 Days

Healthy volunteers

Inclusion criteria

Newborns diagnosed with sepsis

Exclusion criteria

Newborns receiving antibiotic treatment

Design outcomes

Primary

Measure	Time frame	Description
Blood Culture Contamination Rate	1 year	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.

Countries

Turkey (Türkiye)

Outcome results

None listed

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