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

Ain Shams University

Status and phase

Completed

Phase 4

Conditions

Neonatal Sepsis

Treatments

Drug: rh-GCSF

Study type

Interventional

Funder types

Other

Identifiers

NCT01479114

MREC 09030

Details and patient eligibility

About

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

Full 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.

Enrollment

90 patients

Sex

All

Ages

Under 4 weeks old

Volunteers

Accepts Healthy Volunteers

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