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

Neonatal Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01479114
• Other study ID #: MREC 09030
• Status: Completed
• Phase: Phase 4
• First received: November 21, 2011
• Last updated: November 24, 2011
• Start date: April 2009
• Est. completion date: May 2010

Study information

• Verified date: November 2011
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Health, Drug Policy and Planning Center
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 4 Weeks

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neonatal Sepsis

Intervention

Drug:
• rh-GCSF
10 ug/kg/day intravenously for 3 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	all cause mortality		one month	No