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Evaluating Antimicrobial Stewardship Compliance in a Neonatal ICU: A Retrospective Review

Assessing Compliance with Antimicrobial Stewardship in the NICU: A Single-Center Retrospective Study - nil

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/03/082460
Enrollment
1500
Registered
2025-03-17
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Health Condition 1: P368- Other bacterial sepsis of newborn

Interventions

Intervention1: NIL: NIL

Sponsors

Bharati hospital and research centre
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion criteria: Neonates admitted to the NICU who received at least one course of antibiotic therapy. Patients with documented indications for antibiotic use, including suspected or confirmed sepsis, pneumonia, NEC, or other infections. Neonates with available blood culture reports. Medical records with complete documentation of antibiotic prescriptions, including drug selection, dosing, duration, and de-escalation. Neonates who survived beyond 48 hours after antibiotic initiation and remained in the NICU to allow assessment of de-escalation practices.

Exclusion criteria

Exclusion criteria: Exclusion criteria: Patients with incomplete medical records or missing documentation of antibiotic prescriptions, culture results, or treatment modifications. Neonates who expired or were transferred before culture results became available. Cases where antibiotics were started but discontinued within 24 hours due to an alternative diagnosis or clinical improvement without confirmed infection.

Design outcomes

Primary

MeasureTime frame
AIM: To assess compliance with antimicrobial stewardship practices in the neonatal intensive care unit (NICU). Timepoint: 1 year (jan 2024-dec 2024)

Secondary

MeasureTime frame
OBJECTIVES: 1. To determine the percentage of neonates in the NICU with negative blood cultures whose antibiotic therapy was discontinued within 48 hours of culture availability, as per retrospective documented chart records. 2. To assess the percentage of neonates in the NICU with positive blood cultures for whom antibiotic therapy was de-escalated by narrowing the spectrum within 72 hours of culture availability, as per documentation in retrospective chart records. 3. To determine the percentage of neonates in the NICU with positive blood cultures who had their antibiotic therapy changed to a different agent based on sensitivity reports, as per available documented retrospective chart records. Timepoint: 1 year (jan 2024-dec 2024)

Countries

India

Contacts

Public ContactDr Nandini Malshe

bharati vidyapeeth deemed to be university pune

malshenandini@gmail.com9822850716

Outcome results

None listed

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