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To see the role of oral zinc supplementation in reduction of mortality in neonatal sepsis

Role of oral zinc supplementation in reduction of mortality in neonatal sepsis

Status
Active, not recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/07/044228
Enrollment
260
Registered
2022-07-21
Start date
Unknown
Completion date
Unknown
Last updated
2022-08-02

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 Health Condition 2: P369- Bacterial sepsis of newborn, unspecified

Interventions

Intervention1: Zinc with antibiotics: Oral zinc will be given in the dose of 3mg/kg twice a day for 10 days.Blood samples will be taken for zinc estimation at baseline and after 10th day of interventi

Sponsors

Pediatric Department Research Fund
Lead Sponsor
Dr Anumodan Gupta
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1. Neonates more than or equal to 32 weeks gestation 2. Age 3. On significant enteral feeds (more than 50%) 4. Infants considered to be septic includes any of the following ; i) Infant having predisposing factors like prom, foul smelling liquor or more than 3 pv examination during 24 hours ii) Rds with radiological signs of pneumonia 5.Atleast 2 of the screening tests positive for sepsis (Procalcitonin, CRP, ANC, TLC, Micro ESR, immature/total neutrophil)

Exclusion criteria

Exclusion criteria: Neonates with: 1. Major congenital malformation 2. Necrotizing enterocolitis 3. Who have undergone surgery 4. With Apgar score

Design outcomes

Primary

MeasureTime frame
Case fatality â?? proportion of children who die of sepsis and at any time after enrolment while hospitalised.Timepoint: 10 days

Secondary

MeasureTime frame
i)Reduction in Use of 2nd/3rd line antibiotics ii)Reduction in hospital stay. Timepoint: 10 days

Countries

India

Contacts

Public ContactDr Ishita Mahajan

Government medical college Jammu

gs_saini63@yahoo.com9419193571

Outcome results

None listed

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