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

Sir Takhtasinhji General Hospital

Status and phase: Completed; Phase 4

Conditions: Very Low Birth Weight Baby; Neonatal SEPSIS

Treatments: Drug: IgM rich Immunoglobin

Study type: Interventional

Funder types: Other

Identifiers

NCT03403530

svjindal

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 1 to 30 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups, including a placebo group

case group

Active Comparator group

Description:

'IgM rich immunoglobulin' intravenous infusion in the dose of 5 ml/ kg/ dose over 3 hours once a day for 3 days.

Treatment:

Drug: IgM rich Immunoglobin

control group

Placebo Comparator group

Description:

antibiotics only

Treatment:

Drug: IgM rich Immunoglobin