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Intravenous Immunoglobulin in Prevention of Preterm Neonatal Sepsis

Primary Purpose

Neonatal Sepsis

Status
Completed
Phase
Phase 3
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
IVIG
Sponsored by
Hormozgan University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Neonatal Sepsis

Eligibility Criteria

1 Day - 7 Days (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shahid Mohammadi hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

IVIG

Control

Arm Description

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

No intervention

Outcomes

Primary Outcome Measures

Mortality
Death from sepsis or its related complications

Secondary Outcome Measures

Total number of days of hospitalization
Duration of hospitalization
Intraventricular Hemorrhage
occurrence of Intraventricular Hemorrhage
Necrotizing enterocolitis
occurrence of Necrotizing enterocolitis
Bronchopulmonary dysplasia
occurrence of Bronchopulmonary dysplasia

Full Information

First Posted
November 2, 2016
Last Updated
November 2, 2016
Sponsor
Hormozgan University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02954926
Brief Title
Intravenous Immunoglobulin in Prevention of Preterm Neonatal Sepsis
Official Title
Effect of Intravenous Immunoglobulin in Prevention of Preterm Neonatal Sepsis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hormozgan University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Sepsis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IVIG
Arm Type
Experimental
Arm Description
IVIG at a dose of 500mg/kg within 12 h and 3 days of birth
Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Drug
Intervention Name(s)
IVIG
Intervention Description
IVIG at a dose of 500mg/kg within 12 h and 3 days of birth
Primary Outcome Measure Information:
Title
Mortality
Description
Death from sepsis or its related complications
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Total number of days of hospitalization
Description
Duration of hospitalization
Time Frame
7 days
Title
Intraventricular Hemorrhage
Description
occurrence of Intraventricular Hemorrhage
Time Frame
7 days
Title
Necrotizing enterocolitis
Description
occurrence of Necrotizing enterocolitis
Time Frame
7 days
Title
Bronchopulmonary dysplasia
Description
occurrence of Bronchopulmonary dysplasia
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
7 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Shahid Mohammadi hospital
City
Bandar Abbas
State/Province
Hormozgan
ZIP/Postal Code
79176
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Intravenous Immunoglobulin in Prevention of Preterm Neonatal Sepsis

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