Effect of Recombinant Human Granulocyte Colony- Stimulating Factor on CD11b in Septic Neonates

In Vivo Effect of Recombinant Human Granulocyte Colony- Stimulating Factor on Neutrophilic Expression of CD11b in Septic Neonates

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01479114

Enrollment

Registered

2011-11-24

Start date

2009-04-30

Completion date

2010-05-31

Last updated

2011-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal Sepsis

Brief summary

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

Detailed description

Neonates are susceptible to septicemia secondary to quantitative and qualitative neutrophilic defects. Granulocyte-colony stimulating factor (G-CSF) stimulates myeloid progenitor cell proliferation and induces selective neutrophil functions.

Interventions

DRUGrh-GCSF

10 ug/kg/day intravenously for 3 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

No minimum to 4 Weeks

Healthy volunteers

Yes

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame
all cause mortality	one month

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026