NCT02954926

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Nov 2015

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

November 2, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 4, 2016

Completed
Last Updated

November 4, 2016

Status Verified

November 1, 2016

Enrollment Period

11 months

First QC Date

November 2, 2016

Last Update Submit

November 2, 2016

Conditions

Neonatal Sepsis

Outcome Measures

Primary Outcomes (1)

  • Mortality

    Death from sepsis or its related complications

    7 days

Secondary Outcomes (4)

  • Total number of days of hospitalization

    7 days

  • Intraventricular Hemorrhage

    7 days

  • Necrotizing enterocolitis

    7 days

  • Bronchopulmonary dysplasia

    7 days

Study Arms (2)

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

IVIGDRUG

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

IVIG

Eligibility Criteria

Age1 Day - 7 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shahid Mohammadi hospital

Bandar Abbas, Hormozgan, 79176, Iran

Location

MeSH Terms

Conditions

Neonatal Sepsis

Interventions

Immunoglobulins, Intravenous

Condition Hierarchy (Ancestors)

SepsisInfectionsInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Immunoglobulin GImmunoglobulin IsotypesAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident of internal medicine

Study Record Dates

First Submitted

November 2, 2016

First Posted

November 4, 2016

Study Start

November 1, 2015

Primary Completion

October 1, 2016

Study Completion

November 1, 2016

Last Updated

November 4, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations

IR(1)