Status:
COMPLETED
Efficacy of IgM Rich Immunoglobulin With Antibiotics for Bacterial Sepsis in Very Low Birth Weight Preterm Neonates
Lead Sponsor:
Sir Takhtasinhji General Hospital
Conditions:
Neonatal SEPSIS
Very Low Birth Weight Baby
Eligibility:
All Genders
1-30 years
Phase:
PHASE4
Brief Summary
Study comprises of giving IVIG to half of the septic VLBW preterm neonates along with ongoing antibiotics and placebo to the other half. The immunoglobulin will be given for 3 days and neonates will b...
Eligibility Criteria
Inclusion
- Preterm
- Very low birth weight baby: birth weight 1-1.5 kg
- Both inside and outside delivered babies
- Gender: males and females
- Probable severe sepsis (septic score)
Exclusion
- Extremely low birth weight babies: \< 1 kg
- Babies \>1.5 kg birth weight
- Babies born with congenital malformations
- Full term babies
- IUGR babies
- Child with no signs of sepsis
- HBsAg Positive
- HIV Positive
Key Trial Info
Start Date :
January 30 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2018
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03403530
Start Date
January 30 2018
End Date
September 30 2018
Last Update
July 7 2020
Active Locations (1)
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1
NICU, Sir T Hospital, Bhavnagar
Bhavnagar, Gujarat, India, 364002