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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-30

Study Completion Date

2018-09-30

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.

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Detailed Description

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Conditions

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Neonatal SEPSIS Very Low Birth Weight Baby

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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case group

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

Group Type ACTIVE_COMPARATOR

IgM rich Immunoglobin

Intervention Type DRUG

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

control group

antibiotics only

Group Type PLACEBO_COMPARATOR

IgM rich Immunoglobin

Intervention Type DRUG

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

Interventions

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IgM rich Immunoglobin

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

Intervention Type DRUG

Other Intervention Names

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Pentaglobin®

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

Minimum Eligible Age

1 Day

Maximum Eligible Age

30 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No