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Completed

NCT Number: NCT02954926

Intravenous Immunoglobulin in Prevention of Preterm Neonatal Sepsis

Majority of healthcare authorities believe that due to the methodological weakness and small number of patients in conducted therapeutic trials, the evidences are insufficient to support the efficacy of intravenous immunoglobulin (IVIG) in prevention of preterm neonatal sepsis. The objective of this research is to determine the effect of intravenous immunoglobulin in prevention of preterm neonatal sepsis.

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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

Age range

1 day–7 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Shahid Mohammadi hospital

Bandar Abbas, Hormozgan, 79176, Iran

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Born alive before 37 weeks of pregnancy (preterm neonates)
  • Under 2500 g at birth

Exclusion criteria

  • lethal anomaly
  • congenital heart disease
  • TORCH infection
  • severe asphyxia

Treatment and study plan

IVIG

Drug

IVIG at a dose of 500mg/kg within 12 h and 3 days of birth

Primary outcomes

  1. Mortality

    Time frame: 7 days

    Death from sepsis or its related complications

Secondary outcomes

  1. Total number of days of hospitalization

    Time frame: 7 days

    Duration of hospitalization

  2. Intraventricular Hemorrhage

    Time frame: 7 days

    occurrence of Intraventricular Hemorrhage

  3. Necrotizing enterocolitis

    Time frame: 7 days

    occurrence of Necrotizing enterocolitis

  4. Bronchopulmonary dysplasia

    Time frame: 7 days

    occurrence of Bronchopulmonary dysplasia

Sponsors and collaborators

Lead sponsor

Hormozgan University of Medical Sciences

Other

Registry information

Official study title

Effect of Intravenous Immunoglobulin in Prevention of Preterm Neonatal Sepsis

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Nov 4, 2016
Registry last updated
Nov 4, 2016

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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