Intravenous Immunoglobulin in Prevention of Preterm Neonatal Sepsis

November 2, 2016 updated by: Hamidreza Mahboobi, Hormozgan University of Medical Sciences

Effect of 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

92

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 1 week (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
No intervention
Experimental: IVIG
IVIG at a dose of 500mg/kg within 12 h and 3 days of birth
Drug: IVIG
IVIG at a dose of 500mg/kg within 12 h and 3 days of birth

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 7 days
Death from sepsis or its related complications
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total number of days of hospitalization
Time Frame: 7 days
Duration of hospitalization
7 days
Intraventricular Hemorrhage
Time Frame: 7 days
occurrence of Intraventricular Hemorrhage
7 days
Necrotizing enterocolitis
Time Frame: 7 days
occurrence of Necrotizing enterocolitis
7 days
Bronchopulmonary dysplasia
Time Frame: 7 days
occurrence of Bronchopulmonary dysplasia
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hormozgan University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

November 2, 2016

First Submitted That Met QC Criteria

November 2, 2016

First Posted (Estimate)

November 4, 2016

Study Record Updates

Last Update Posted (Estimate)

November 4, 2016

Last Update Submitted That Met QC Criteria

November 2, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUMS.REC.1394.162

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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