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

D

Dr. Behcet Uz Children's Hospital

Status

Completed

Conditions

Newborn; Infection

Treatments

Other: Blood Culture Bundle

Study type

Interventional

Funder types

Other

Identifiers

NCT06637696
BU-OK-01

Details and patient eligibility

About

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).

Full 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).

Enrollment

320 patients

Sex

All

Ages

1 to 28 days old

Volunteers

No Healthy Volunteers

Inclusion criteria

Newborns diagnosed with sepsis

Exclusion criteria

Newborns receiving antibiotic treatment

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

Single Blind

320 participants in 2 patient groups, including a placebo group

Blood Culture Bundle Group
Active Comparator group
Description:
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.
Treatment:
Other: Blood Culture Bundle
Control Blood Culture Group
Placebo Comparator group
Description:
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.
Treatment:
Other: Blood Culture Bundle

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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