Efficacy of IgM Rich Immunoglobulin With Antibiotics for Bacterial Sepsis in Very Low Birth Weight Preterm Neonates (IgMNS)
Primary Purpose
Neonatal SEPSIS, Very Low Birth Weight Baby
Status
Completed
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
IgM rich Immunoglobin
Sponsored by
About this trial
This is an interventional treatment trial for Neonatal SEPSIS focused on measuring IgM, Immunoglobulin, Neonatal sepsis, very low birth weight preterm
Eligibility 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
Sites / Locations
- NICU, Sir T Hospital, Bhavnagar
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
case group
control group
Arm Description
'IgM rich immunoglobulin' intravenous infusion in the dose of 5 ml/ kg/ dose over 3 hours once a day for 3 days.
antibiotics only
Outcomes
Primary Outcome Measures
Discharge rates
patients who received IgM rich Immunoglobin along with antibiotics have better outcome as compared to the patients who receive only antibiotics.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT03403530
First Posted
January 1, 2018
Last Updated
July 3, 2020
Sponsor
Sir Takhtasinhji General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03403530
Brief Title
Efficacy of IgM Rich Immunoglobulin With Antibiotics for Bacterial Sepsis in Very Low Birth Weight Preterm Neonates
Acronym
IgMNS
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
January 30, 2018 (Actual)
Primary Completion Date
June 30, 2018 (Actual)
Study Completion Date
September 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sir Takhtasinhji General Hospital
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal SEPSIS, Very Low Birth Weight Baby
Keywords
IgM, Immunoglobulin, Neonatal sepsis, very low birth weight preterm
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
case group
Arm Type
Active Comparator
Arm Description
'IgM rich immunoglobulin' intravenous infusion in the dose of 5 ml/ kg/ dose over 3 hours once a day for 3 days.
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
antibiotics only
Intervention Type
Drug
Intervention Name(s)
IgM rich Immunoglobin
Other Intervention Name(s)
Pentaglobin®
Intervention Description
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
Primary Outcome Measure Information:
Title
Discharge rates
Description
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 Outcome Measure Information:
Title
Duration of hospital stay
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
30 Days
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jayendra R Gohil, MD
Organizational Affiliation
SirTakhtasinhjiGH, Prof Pediatrics, Govt MC, Bhavnagar
Official's Role
Principal Investigator
Facility Information:
Facility Name
NICU, Sir T Hospital, Bhavnagar
City
Bhavnagar
State/Province
Gujarat
ZIP/Postal Code
364002
Country
India
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25674546
Citation
Capasso L, Borrelli A, Cerullo J, Pisanti R, Figliuolo C, Izzo F, Paccone M, Ferrara T, Lama S, Raimondi F. Role of immunoglobulins in neonatal sepsis. Transl Med UniSa. 2014 Dec 19;11:28-33. eCollection 2015 Jan-Apr.
Results Reference
result
PubMed Identifier
3195529
Citation
Haque KN, Zaidi MH, Bahakim H. IgM-enriched intravenous immunoglobulin therapy in neonatal sepsis. Am J Dis Child. 1988 Dec;142(12):1293-6. doi: 10.1001/archpedi.1988.02150120047038.
Results Reference
result
Learn more about this trial
Efficacy of IgM Rich Immunoglobulin With Antibiotics for Bacterial Sepsis in Very Low Birth Weight Preterm Neonates
We'll reach out to this number within 24 hrs