FindTrial
Sign In

A study to know the efficacy of adjuvant IgM in reducing mortality of very low birth weight newborns with sepsis

A randomised study to assess the role of adjuvant IgM enriched Intravenous Immunoglobulin on mortality of Very Low Birth Weight new-borns with sepsis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/09/045566
Enrollment
160
Registered
2022-09-15
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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: IgM enriched Intravenous Immunoglobulin: 5 ml per Kg intravenous infusion for 3 days Control Intervention1: Not Applicable: Not applicable

Sponsors

Dr Rinku Saini
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. All Very Low Birth Weight newborns (1-1.499 kg) with sepsis 2. Prior written informed consent signed by the legal guardian

Exclusion criteria

Exclusion criteria: 1. Very Low Birth Weight new-borns with congenital anomalies & TORCH infections 2. Refusal for consent 3. Very low birth weight newborns 4. Severely ill septic VLBW newborns (with shock and/or requiring mechanical ventilation).

Design outcomes

Primary

MeasureTime frame
All cause mortalityTimepoint: 1 month—

Secondary

MeasureTime frame
-Incidence of Intracranial haemorrhageTimepoint: 1 month;duration of hospital stayTimepoint: 1 month;Incidence of Bronchopulmonary dysplasiaTimepoint: 1 month;Incidence of Necrotizing enterocolitisTimepoint: 1 month—

Countries

India

Contacts

Public ContactDr Rinku Saini

SMS Medical College, Jaipur

dr.rinkusaini@gmail.com9001986353

Outcome results

None listed

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