International neonatal immunotherapy study

Phase 3

Completed

• Conditions: Infants with sepsis. Infants being treated with antibiotics are eligible. Infants can be preterm or term.; Reproductive Health and Childbirth - Childbirth and postnatal care; Inflammatory and Immune System - Other inflammatory or immune system disorders

• Registration Number: ACTRN12606000273583
• Lead Sponsor: The University of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2001-07-12
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

Infants are eligible if: they are receiving antibiotics with clinical evidence of definite or highly probable sepsis, there is substantial uncertainty that IVIG is indicated, birth weight is less than 1500g OR already has positive blood or cerebro spinal fluid culture OR receiving artifical ventilation.

Exclusion Criteria

IVIG already given or thought to be needed or contra-indicated.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality or major disability[At 2 yrs (corrected for gestational age at birth)]

Secondary Outcome Measures

Name	Time	Method
1. Mortality[Before 2 years];Chronic lung disease or major cerebral abnormality[Before hospital discharge.];Significant positive culture[After trial entry.];Pneumonia[hospital discharge];Necrotising enterocolitis[hospital discharge];Duration of respiratory support. [hospital discharge];2. Major disability and Non major disability[At 2 years];3. Length of hospital stay and number of hospital admissions.[2 years (corrected for gestational age at birth)]