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

Phase 4

Completed

• Conditions: Neonatal SEPSIS; Very Low Birth Weight Baby
• Interventions: Drug: IgM rich Immunoglobin

• Registration Number: NCT03403530
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-01
• Study First Submitted QC: 2018-01-11
• Study First Posted: 2018-01-18
• Study Start: 2018-01-30
• Primary Completion: 2018-06-30
• Study Completion: 2018-09-30
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-03
• Last Update Posted: 2020-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
case group	IgM rich Immunoglobin	'IgM rich immunoglobulin' intravenous infusion in the dose of 5 ml/ kg/ dose over 3 hours once a day for 3 days.
control group	IgM rich Immunoglobin	antibiotics only

Primary Outcome Measures

Name	Time	Method
Discharge rates	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

Name	Time	Method
Duration of hospital stay	6 months	patients who received IgM rich Immunoglobin along with antibiotics have better outcome as compared to the patients who receive only antibiotics.

Trial Locations

Locations (1)

NICU, Sir T Hospital, Bhavnagar; 🇮🇳 Bhavnagar, Gujarat, India