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Comparison of two guidelines for identifying risk of early onset sepsis in neonates.

Comparison of Kaiser Permanente sepsis risk calculator with the Centre for disease control guidelines for the use of antibiotics in suspected early onset sepsis in neonates more than 34 weeks of gestation.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/01/030293
Enrollment
202
Registered
2021-01-06
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

None listed

Sponsors

Vardhman Mahavir Medical College and Safdarjung Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All live inborn neonates with gestation more than 34 weeks with risk factors for early-onset neonatal sepsis

Exclusion criteria

Exclusion criteria: Major congenital malformtions Moderate to severe perinatal asphyxia (APGAR <6 at 5 minutes)

Design outcomes

Primary

MeasureTime frame
Number of neonates with antibiotics administration in suspected early onset sepsis in two groups using KP sepsis risk calculator and CDC guidelinesTimepoint: 72 hours—

Secondary

MeasureTime frame
agreement rate (kappa) between gram positive and gram negative culture positive sepsis in the two groupsTimepoint: 72 hours;agreement rate (kappa) for antibiotic administration between the two groupsTimepoint: 72 hours;No of neonates with clinical sepsis or culture positive sepsis within 72 hours in two groupsTimepoint: 72 hours—

Countries

India

Contacts

Public ContactPreethi R

Vardhman Mahavir Medical College and Safdarjung Hospital

drpkdebata@gmail.com7291000664

Outcome results

None listed

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