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To study the role of giving intravenous immunoglobulin injection for treatment of septicemia in newborn babies.

Role of intravenous immunoglobulin in the management of neonatal sepsis : A randomized controlled trial.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/08/027019
Enrollment
60
Registered
2020-08-07
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: R652- Severe sepsis

Interventions

Intervention1: Intravenous Immunoglobulin: Human Normal Immunoglobulin 5 % solution(5gm/100ml)b.Brand Name - GLOBUCEL Content:Total Protien 50 gm/dl immunoglobulin G 95% Maltose- 100gm/L

Sponsors

MLN Medical College Prayagraj Uttar Pradesh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Neonates with clinical signs of sepsis and positive sepsis screen. 2.Neonates with positive blood culture. 3.Neonates with septic meningitis diagnosed on basis of biochemical and microbiological examination or CSF culture.

Exclusion criteria

Exclusion criteria: 1.All neonates whose attendants did not give consent for IVIG administration. 2.All neonates whose attendants who did not give consent to involve in Study. 3.All neonates with major congenital malformation. 4.All neonates with known metabolic disease. 5.Neonates in shock or require positive pressure ventilation at the time of admission.

Design outcomes

Primary

MeasureTime frame
Number of days of admission in hospitalTimepoint: 7 days and 30 days

Secondary

MeasureTime frame
Mortality rate. Weight gain during hospital course Need for ventilation. Number of days of Oxygen requirement. Development of necrotizing enterocolitis. Side effects of IvIg. Timepoint: 1day and 30 days

Countries

India

Contacts

Public ContactDr Mohammad Qaim Rizvi

Motilal Nehru Medical College

mukeshvirsingh@gmail.com9456630304

Outcome results

None listed

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