Intravenous Immunoglobulin in Prevention of Preterm Neona... | NCT02954926

Studies
Intravenous Immunoglobulin in Prevention of Preterm Neonatal Sepsis

NCT02954926

Sponsor

Hormozgan University of Medical Sciences

Status

Completed

Last Update Posted

Nov 4, 2016Estimated

Enrollment

92Actual

Phase

Phase 3

Conditions

Neonatal Sepsis

Interventions

IVIG

Countries

Iran

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2015

Primary Completion Date

Oct 2016Actual

Completion Date

Nov 2016Actual

First Submitted Date

Nov 2, 2016

First Submission Date that Met QC Criteria

Nov 2, 2016

First Posted Date

Nov 4, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 2, 2016

Last Update Posted Date

Nov 4, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hamidreza Mahboobi, Resident of internal medicine, Hormozgan University of Medical SciencesPrincipal Investigator

Lead Sponsor

Hormozgan University of Medical SciencesOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

92Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
IVIG	Experimental	IVIG at a dose of 500mg/kg within 12 h and 3 days of birth	Drug: IVIG
Control	No Intervention	No intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
IVIG	Drug	IVIG at a dose of 500mg/kg within 12 h and 3 days of birth	IVIG

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Total number of days of hospitalization	Duration of hospitalization	7 days
Intraventricular Hemorrhage	occurrence of Intraventricular Hemorrhage

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Day

Maximum Age

7 Days

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shahid Mohammadi hospital		Bandar Abbas	Hormozgan	79176	Iran

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000071074	Neonatal Sepsis

Ancestor Terms

ID	Term
D018805	Sepsis
D007239	Infections
D007232	Infant, Newborn, Diseases
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D016756	Immunoglobulins, Intravenous

Ancestor Terms

ID	Term
D007074	Immunoglobulin G
D007132	Immunoglobulin Isotypes
D000906	Antibodies
D007136	Immunoglobulins

Browse Leaves

Not provided

Browse Branches

Not provided