Effect of Intravenous Immunoglobulins in newly born babies with infections

Intravenous Immunoglobulin in Neonatal Sepsis

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/12/010810

Enrollment

100

Registered

2017-12-07

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: null- Patients in both the arm were suffering from early onset neonatal sepsis and received the standard supportive care as per institutional protocol at time of recruitment

Interventions

Intervention1: Intravenous immunoglobulins: Human normal immunoglobulin Control Intervention1: 0.9% NaCl: Normal saline

Eligibility

Inclusion criteria

Inclusion criteria: neonates with clinical suspicion of sepsis with at least two sepsis screen markers positive, with positive blood culture showing no clinical improvement (as per SNAPII score)9 after 48 hours of antibiotic therapy.

Exclusion criteria

Exclusion criteria: Life threatening congenital malformations. (Meningomyelocele, Encephalocele etc.) and transfusion of blood components before enrolment.

Design outcomes

Primary

Measure	Time frame
Efficacy of IVIG in neonatal sepsis in tertiary care hospital 2. Morbidities of babies with early onset neonatal sepsisTimepoint: Decrease in SNAP II score after 72 hour of administration of IVIG	—

Secondary

Measure	Time frame
Morbidities of babies suffering from early onset neonatal sepsisTimepoint: Duration of hospitalisation in hours of babies with early onset neonatal sepsis followed up till death or discharge from hospital	—

Countries

India

Contacts

Public ContactSanjukta Panda

Veer Surendra Sai Institute of Medical Sciences and Research (VIMSAR)

drnihar.mishra@gmail.com9337797072

Outcome results

None listed

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