NCT01479114

Brief Summary

The investigators aimed to evaluate the effect of G-CSF administration in septic neonates on neutrophil production and CD11b expression.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Apr 2009

Shorter than P25 for phase_4

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

April 1, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

November 21, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 24, 2011

Completed
Last Updated

November 28, 2011

Status Verified

November 1, 2011

Enrollment Period

1.1 years

First QC Date

November 21, 2011

Last Update Submit

November 24, 2011

Conditions

Neonatal Sepsis

Outcome Measures

Primary Outcomes (1)

  • all cause mortality

    one month

Study Arms (3)

control group

NO INTERVENTION

G-CSF group

EXPERIMENTAL
Drug: rh-GCSF

Non-GCSF group

NO INTERVENTION

Interventions

rh-GCSFDRUG

10 ug/kg/day intravenously for 3 days

Also known as: Granulocyte colony stimulating factor,neubogen,filgstrim
G-CSF group

Eligibility Criteria

AgeUp to 4 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • newborn infants with postnatal age \< 28 day,
  • minimum gestational age of 28 weeks and requiring intensive care with clinical signs consistent with the diagnosis of neonatal sepsis,
  • with or without neutropenia

You may not qualify if:

  • neonates with congenital malformation,
  • major chromosomal abnormalities,
  • prior use of cytokines or intravenous immunoglobulin, or decreased hemoglobin and/or hematocrit at or below the levels necessitate transfusion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Neonatal Sepsis

Interventions

Granulocyte Colony-Stimulating Factor

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Colony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

November 21, 2011

First Posted

November 24, 2011

Study Start

April 1, 2009

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

November 28, 2011

Record last verified: 2011-11