None listed
Conditions
Interventions
Intervention1: Zinc Sulphate 1mg/Kg: Till discharge from hospital
Control Intervention1: Placebo: Till discharge from hospital
Sponsors
Nil
Eligibility
Inclusion criteria
Inclusion criteria: Inborn and Outborn neonates >32 weeks (By Ballard scoring) with Probable Neonatal Sepsis* will be included in this study. *According to the guidelines formulated by the National Neonatology Forum of India based on the duly approved tenth revision of the International Classification of Diseases (ICD) by the WHO, in an infant having a clinical picture suggestive of sepsis, the presence of any one of the following criteria is enough to suspect the diagnosis of Bacterial Infection: 1) Existence of any of the predisposing factors like Premature Rupture of membranes (PROM), foul smelling liquor, Amnionitis or Funisitis, Gastric Polymorphs of more than 5/HPF. 2) Positive sepsis screen i.e. presence of atleast two of the following five parameters, namely, total leucocyte count < 5000/mm3, Low absolute neutrophil count (as per standard charts), Bands to Total neutrophil ratio (IT Ratio) of >0.2, C-Reactive Protein > 1mg/dl, Micro ESR > 15mm in first hour on any day of life/ age in days+3
Exclusion criteria
Exclusion criteria: The following categories of babies will be excluded from the trial: Preterm neonates < 32 weeks Neonates with Congenital Malformations Neonates with NEC
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Decrease in MortalityTimepoint: 10 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Duration of hospital stay (in hours) 2) Requirement of higher lines of antibiotic therapy (based on clinical assessment and culture reports) Timepoint: 10 days | — |
Countries
Nepal
Contacts
Public ContactKayur Mehta
B. P. Koirala Institute of Health Sciences
Outcome results
None listed