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

NCT03403530 | Completed Phase 4 DMC

• 1 other identifier: svjindal
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Neonatal SEPSIS; Very Low Birth Weight Baby

Keywords

IgM; Immunoglobulin; Neonatal sepsis; very low birth weight preterm

Outcome Measures

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.

  6 months

Secondary Outcomes (1)

• Duration of hospital stay

  6 months

Study Arms (2)

case group

ACTIVE COMPARATOR

'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

control group

PLACEBO COMPARATOR

antibiotics only

Drug: IgM rich Immunoglobin

Interventions

IgM rich Immunoglobin 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

Also known as: Pentaglobin®

case group; control group

Eligibility Criteria

• Age: 1 Day - 30 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Sir Takhtasinhji General Hospital: lead

Study Sites (1)

NICU, Sir T Hospital, Bhavnagar

Bhavnagar, Gujarat, 364002, India

Location

Related Publications (2)

• 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.

  PMID: 25674546 RESULT

• 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.

  PMID: 3195529 RESULT

MeSH Terms

Conditions

Neonatal Sepsis

Interventions

pentaglobulin

Condition Hierarchy (Ancestors)

Sepsis; Infections; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jayendra R Gohil, MD

  SirTakhtasinhjiGH, Prof Pediatrics, Govt MC, Bhavnagar

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Resident

Study Record Dates

• First Submitted: January 1, 2018
• First Posted: January 18, 2018
• Study Start: January 30, 2018
• Primary Completion: June 30, 2018
• Study Completion: September 30, 2018
• Last Updated: July 7, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)