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Effect of keeping blood culture system inside neonatal ICU in decreasing antibiotics usage in newborn

Point of care vs central lab BACTEC in decreasing antibiotic use in NICU- A randomized control trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/12/038372
Enrollment
242
Registered
2021-12-02
Start date
Unknown
Completion date
Unknown
Last updated
2022-02-21

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

Conditions

Health Condition 1: P369- Bacterial sepsis of newborn, unspecified

Interventions

Intervention1: blood culture system inside NICU: blood cultures are incubated in BACTEC unit for 5 days within NICU premises and sent to central lab for plating only if it flags red Control Interventi

Sponsors

All India institute of medical sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All inborn neonates of the institute admitted in NICU warranting antibiotics for the first time

Exclusion criteria

Exclusion criteria: syndromic infants or infants with malformations, inability to collect blood culture before starting antibiotics, infants with suspected bone and joint infections, infants with surgical conditions warranting surgery

Design outcomes

Primary

MeasureTime frame
to compare the number of antibiotic dosage in neonates warranting antibiotics for suspected sepsis between two groupsTimepoint: discharge—

Secondary

MeasureTime frame
to compare number of antibiotics dosages in whole cohort including culture positive sepsis among the two groupsTimepoint: at discharge;to compare the blood culture positivity rate in both groupsTimepoint: at discharge;to compare the days of therapy in both groupsTimepoint: at discharge;to compare the duration of hospital stay in hours in both groupsTimepoint: at discharge;to compare the incidence of necrotising enterocolitis in both groupsTimepoint: at discharge;to compare the incidence of subsequent development of total sepsis, culture positive sepsis and fungal sepsisTimepoint: at discharge;to compare the mortality in both the groupsTimepoint: at discharge;To compare the number of neonates in which antibiotics were stopped at 48 hoursTimepoint: at discharge;to compare the time taken for detection of positive cultures in both groupsTimepoint: at discharge;to compare the time taken from blood collection to change of antibiotics as per sensitivity pattern in both groupsTimepoint: at discharge—

Countries

India

Contacts

Public ContactSushil Kumar Choudhary

All India institute of medical sciences, Jodhpur

choudharysk@aiimsjodhpur.edu.in9013355932

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026