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

Sir Takhtasinhji General Hospital60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Neonatal SEPSIS Very Low Birth Weight Baby

Interventions

IgM rich ImmunoglobinDRUG

the 'IgM rich immunoglobn' is the normal human immunoglobin containing Human plasma protein 50mg/ml of which immunoglobin is atleast 95% Immunoglobin M (IgM) 6mg Immunoglobin A (IgA) 6mg Immunoglobin G (IgG) 38mg

Eligibility

Sex: ALLMin age: 1 DayMax age: 30 Days

Medical Language ↔ Plain English

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

Locations (1)

NICU, Sir T Hospital, Bhavnagar

Bhavnagar, Gujarat, India

Outcomes

Primary Outcomes

Discharge rates

patients who received IgM rich Immunoglobin along with antibiotics have better outcome as compared to the patients who receive only antibiotics.

Time frame: 6 months

Secondary Outcomes

Duration of hospital stay

patients who received IgM rich Immunoglobin along with antibiotics have better outcome as compared to the patients who receive only antibiotics.

Time frame: 6 months

Data from ClinicalTrials.gov

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