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CompletedNCT02954926Updated Nov 4, 2016

Intravenous Immunoglobulin in Prevention of Preterm Neonatal Sepsis

A Phase 3 interventional study of IVIG in Neonatal Sepsis, sponsored by Hormozgan University of Medical Sciences. Completed at 1 site in Iran, Islamic Republic of. Open to participants aged 1 Day to 7 Days. Per ClinicalTrials.gov, last updated 2016-11-04.

Sponsored by Hormozgan University of Medical Sciences · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
92
Allocation
Randomized
Ages
1 Day to 7 Days
Sex
All
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Study summary

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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Conditions studied

  • Neonatal Sepsis

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03

In context

Neonatal Sepsis

192 studies on the registry are indexed under Neonatal Sepsis; 41 are open to participants now.

This study's enrollment of 92 is below the median of 181 across 102 interventional studies indexed under Neonatal Sepsis.

Browse Neonatal Sepsis studies →

Lead sponsor

Hormozgan University of Medical Sciences is the lead sponsor of 23 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
1 Day to 7 Days
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
92 participants (actual)

Study arms

  • Experimental
    IVIG

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

    Drug: IVIG

  • No intervention
    Control

    No intervention

Interventions

  • DrugIVIG

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

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What researchers measure

Primary outcomes

  1. Mortality

    Death from sepsis or its related complications

    Time frame: 7 days

Secondary outcomes

  1. Total number of days of hospitalization

    Duration of hospitalization

    Time frame: 7 days

  2. Intraventricular Hemorrhage

    occurrence of Intraventricular Hemorrhage

    Time frame: 7 days

  3. Necrotizing enterocolitis

    occurrence of Necrotizing enterocolitis

    Time frame: 7 days

  4. Bronchopulmonary dysplasia

    occurrence of Bronchopulmonary dysplasia

    Time frame: 7 days

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Study locations

1 site
  • Shahid Mohammadi hospital
    Bandar Abbas, Hormozgan 79176, Iran, Islamic Republic of
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 4, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02954926
Lead sponsor
Hormozgan University of Medical Sciences
Responsible party
Hamidreza Mahboobi (Resident of internal medicine, Hormozgan University of Medical Sciences) — Principal investigator
First posted
Nov 4, 2016
Start date
Nov 2015
Primary completion
Oct 2016
Completion
Nov 2016
Last update
Nov 4, 2016

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Immunoglobulins, Intravenous

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