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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01479114
Recruitment Status : Completed
First Posted : November 24, 2011
Last Update Posted : November 28, 2011
Information provided by (Responsible Party):
Rania Ali El-Farrash, 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.

Condition or disease Intervention/treatment Phase
Neonatal Sepsis Drug: rh-GCSF Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: In Vivo Effect of Recombinant Human Granulocyte Colony- Stimulating Factor on Neutrophilic Expression of CD11b in Septic Neonates
Study Start Date : April 2009
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
No Intervention: control group
Experimental: G-CSF group Drug: rh-GCSF
10 ug/kg/day intravenously for 3 days
Other Name: Granulocyte colony stimulating factor,neubogen,filgstrim
No Intervention: Non-GCSF group

Primary Outcome Measures :
  1. all cause mortality [ Time Frame: one month ]

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Ages Eligible for Study:   up to 4 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts 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

Responsible Party: Rania Ali El-Farrash, Dr., Ain Shams University Identifier: NCT01479114     History of Changes
Other Study ID Numbers: MREC 09030
First Posted: November 24, 2011    Key Record Dates
Last Update Posted: November 28, 2011
Last Verified: November 2011

Additional relevant MeSH terms:
Neonatal Sepsis
Infant, Newborn, Diseases
Systemic Inflammatory Response Syndrome
Pathologic Processes
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs