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

Sponsors

Lead Sponsor: Ain Shams University

Source Ain Shams University
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.

Overall Status Completed
Start Date April 2009
Completion Date May 2010
Primary Completion Date May 2010
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
all cause mortality one month
Enrollment 90
Condition
Intervention

Intervention Type: Drug

Intervention Name: rh-GCSF

Description: 10 ug/kg/day intravenously for 3 days

Arm Group Label: G-CSF group

Other Name: Granulocyte colony stimulating factor,neubogen,filgstrim

Eligibility

Criteria:

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

Gender: All

Minimum Age: N/A

Maximum Age: 4 Weeks

Healthy Volunteers: Accepts Healthy Volunteers

Verification Date

November 2011

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Ain Shams University

Investigator Full Name: Rania Ali El-Farrash

Investigator Title: Dr.

Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: control group

Type: No Intervention

Label: G-CSF group

Type: Experimental

Label: Non-GCSF group

Type: No Intervention

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Outcomes Assessor)

Source: ClinicalTrials.gov