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Intravenous Immunoglobulin in Prevention of Preterm Neonatal Sepsis

NCT ID: NCT02954926

Last Updated: 2016-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2016-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Neonatal Sepsis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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IVIG

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

Group Type EXPERIMENTAL

IVIG

Intervention Type DRUG

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

Control

No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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IVIG

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

1 Day

Maximum Eligible Age

7 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hormozgan University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Hamidreza Mahboobi

Resident of internal medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Shahid Mohammadi hospital

Bandar Abbas, Hormozgan, Iran

Site Status

Countries

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Iran

Other Identifiers

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HUMS.REC.1394.162

Identifier Type: -

Identifier Source: org_study_id