Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03403530
Recruitment Status : Completed
First Posted : January 18, 2018
Last Update Posted : April 26, 2019
Sponsor:
Information provided by (Responsible Party):
Sonal V Jindal, Sir Takhtasinhji General Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Neonatal SEPSIS Very Low Birth Weight Baby Drug: IgM rich Immunoglobin Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : January 30, 2018
Actual Primary Completion Date : June 30, 2018
Actual Study Completion Date : September 30, 2018

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Pentaglobin®




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 30 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03403530


Locations
Layout table for location information
India
NICU, Sir T Hospital, Bhavnagar
Bhavnagar, Gujarat, India, 364002
Sponsors and Collaborators
Sir Takhtasinhji General Hospital

Publications of Results:
Layout table for additonal information
Responsible Party: Sonal V Jindal, Principal Investigator, Resident, Sir Takhtasinhji General Hospital
ClinicalTrials.gov Identifier: NCT03403530     History of Changes
Other Study ID Numbers: svjindal
First Posted: January 18, 2018    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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

Keywords provided by Sonal V Jindal, Sir Takhtasinhji General Hospital:
IgM
Immunoglobulin
Neonatal sepsis
very low birth weight preterm

Additional relevant MeSH terms:
Layout table for MeSH terms
Body Weight
Sepsis
Toxemia
Birth Weight
Neonatal Sepsis
Signs and Symptoms
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Infant, Newborn, Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Immunoglobulins
Antibodies
Anti-Infective Agents
Antitubercular Agents
Immunologic Factors
Physiological Effects of Drugs