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CompletedNCT03403530IgMNSUpdated Jul 7, 2020

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

A Phase 4 interventional study of IgM rich Immunoglobin in Neonatal SEPSIS and Very Low Birth Weight Baby, sponsored by Sir Takhtasinhji General Hospital. Completed at 1 site in India. Open to participants aged 1 Day to 30 Days. Per ClinicalTrials.gov, last updated 2020-07-07.

Sponsored by Sir Takhtasinhji General Hospital · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
1 Day to 30 Days
Sex
All
01

Study 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.

02

Conditions studied

  • Neonatal SEPSIS
  • Very Low Birth Weight Baby

Keywords

  • IgM
  • Immunoglobulin
  • Neonatal sepsis
  • very low birth weight preterm
03

Who can participate

Ages eligible
1 Day to 30 Days
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
60 participants (actual)

Study arms

  • 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

  • Placebo comparator
    control group

    antibiotics only

    Drug: IgM rich Immunoglobin

Interventions

  • DrugIgM 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

    Also known as: Pentaglobin®

05

What researchers measure

Primary outcomes

  1. Discharge rates

    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 outcomes

  1. 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.

    Time frame: 6 months

06

Study locations

1 site
  • NICU, Sir T Hospital, Bhavnagar
    Bhavnagar, Gujarat 364002, India
07

References and documents

Publications

  • 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. PubMed 25674546 ↗
  • 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. PubMed 3195529 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03403530
Lead sponsor
Sir Takhtasinhji General Hospital
Responsible party
Sonal V Jindal (Principal Investigator, Resident, Sir Takhtasinhji General Hospital) — Principal investigator
First posted
Jan 18, 2018
Start date
Jan 30, 2018
Primary completion
Jun 30, 2018
Completion
Sep 30, 2018
Last update
Jul 7, 2020

Study contacts

Jayendra R Gohil, MD
principal investigator · SirTakhtasinhjiGH, Prof Pediatrics, Govt MC, Bhavnagar

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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