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

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective Study to Analyze the Efficacy of IgM Rich Immunoglobulin as an Adjunct to Antibiotics in the Treatment of Bacterial Sepsis in Very Low Birth Weight Preterm Neonates

Conditions
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Neonatal SEPSIS, Very Low Birth Weight Baby

Intervention / Treatment
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* Drug: IgM rich Immunoglobin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 30 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: case group<br>'IgM rich immunoglobulin' intravenous infusion in the dose of 5 ml/ kg/ dose over 3 hours once a day for 3 days. | Drug: IgM rich Immunoglobin<br>* 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<br>* Other names: Pentaglobin®;|
| Placebo Comparator: control group<br>antibiotics only | Drug: IgM rich Immunoglobin<br>* 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<br>* Other names: Pentaglobin®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Discharge rates | patients who received IgM rich Immunoglobin along with antibiotics have better outcome as compared to the patients who receive only antibiotics. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IgM, Immunoglobulin, Neonatal sepsis, very low birth weight preterm