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

July 3, 2020 updated by: Sonal V Jindal, Sir Takhtasinhji General Hospital

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Gujarat
      • Bhavnagar, Gujarat, India, 364002
        • NICU, Sir T Hospital, Bhavnagar

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 1 month (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: case group
'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
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
Other Names:
  • Pentaglobin®
Placebo Comparator: control group
antibiotics only
Drug: 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
Other Names:
  • Pentaglobin®

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sir Takhtasinhji General Hospital

Investigators

  • Principal Investigator: Jayendra R Gohil, MD, SirTakhtasinhjiGH, Prof Pediatrics, Govt MC, Bhavnagar

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 30, 2018

Primary Completion (Actual)

June 30, 2018

Study Completion (Actual)

September 30, 2018

Study Registration Dates

First Submitted

January 1, 2018

First Submitted That Met QC Criteria

January 11, 2018

First Posted (Actual)

January 18, 2018

Study Record Updates

Last Update Posted (Actual)

July 7, 2020

Last Update Submitted That Met QC Criteria

July 3, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • svjindal

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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