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Using Simple Blood Test Changes to Identify Early Infection in Full-Term Newborn Babies

To evaluate the utility of red cell distribution width to platelet ratio in early diagnosis of sepsis in term neonates- a case control study - nil

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2026/05/111218
Enrollment
108
Registered
2026-05-27
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

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: Nil: Nil

Sponsors

Datta Meghe Medical College Nagpur
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Cases: Term neonates with sepsis risk factors and clinical characteristics who are admitted to the NICU. Control: Term neonates admitted in NICU without clinically suspected sepsis

Exclusion criteria

Exclusion criteria: 1) Neonates with birth asphyxia 2) Chromosomal abnormalities 3) Low birth weight 4) Birth injuries 5) Meconium Aspiration Syndrome 6) Congenital Malformations 7) Inborn errors of metabolism 8) ABO/ Rh Isoimmunization 9) Parental refusal of consent

Design outcomes

Primary

MeasureTime frame
Diagnostic Accuracy of RDW/Platelet Ratio. Sensitivity: Proportion of true septic cases correctly identified. using RDW/Platelet ratio. Specificity: Proportion of non-septic neonates correctly excluded by the ratio. Timepoint: 4 WEEKS—

Secondary

MeasureTime frame
Diagnostic Accuracy of RDW/Platelet Ratio. Sensitivity: Proportion of true septic cases correctly identified using RDW/Platelet ratio. Specificity: Proportion of non-septic neonates correctly excluded by the ratio. Timepoint: 4 WEEKS—

Countries

India

Contacts

Public ContactDr Chandrakant Bokade

Datta Meghe Medical College, Nagpur

cmbokade77@gmail.com9373111532

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026