International Neonatal Immunotherapy Study

Not Applicable

Completed

• Conditions: Infections and Infestations; Obstetrics and Gynaecology; Sepsis

• Registration Number: ISRCTN94984750
• Lead Sponsor: niversity of Oxford (UK)

Brief Summary

2008 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/19063731 2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21962214

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2000-10-25
• Study Completion: 2008-12-31
• Last Update Posted: 8 March 2021

Recruitment & Eligibility

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

Inclusion Criteria

Infants who:
1. Are receiving antibiotics with clinical evidence of definite or highly probable sepsis
2. There is substantial uncertainty that IVIG is indicated
3. Birth weight is less than 1500 g OR already has positive blood or Cerebral Spinal Fluid (CSF) culture OR receiving artificial ventilation

Exclusion Criteria

IVIG already given or thought to be needed or contraindicated.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality or major disability at 2 years of age (corrected for gestational age at birth).

Secondary Outcome Measures

Name	Time	Method
<br> 1. Short term: mortality, chronic lung disease or major cerebral abnormality before hospital discharge, significant positive culture after trial entry, pneumonia, necrotising enterocolitis, duration of respiratory support<br> 2. Long term: mortality before two years, major disability at 2 years, non-major disability at 2 years.<br> 3. Health service utilisation: length of hospital stay<br>