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Completed

NCT Number: NCT03403530

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

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.

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Key information

Conditions

Neonatal SEPSIS Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant, Newborn, Diseases Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome Very Low Birth Weight Baby

Age range

1 day–30 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

NICU, Sir T Hospital, Bhavnagar

Bhavnagar, Gujarat, 364002, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Pentaglobin®

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Sir Takhtasinhji General Hospital

Other Gov

Registry information

Official study 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

Acronym: IgMNS

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jan 18, 2018
Registry last updated
Jul 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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