Efficacy of IgM Rich Immunoglobulin With Antibiotics for Bacterial Sepsis in Very Low Birth Weight Preterm Neonates

• Status: Completed
• Trial end date: 2018-09-30
• Target enrollment: 0
• Participant gender: All

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 be monitored for the results. The data will be analysed on the basis of blood culture results and outcome of the patients.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sir Takhtasinhji General Hospital
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular; Antibodies; Immunoglobulins

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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