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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rania Ali El-Farrash, Ain Shams University
ClinicalTrials.gov Identifier:
NCT01479114
First received: November 21, 2011
Last updated: November 24, 2011
Last verified: November 2011
  Purpose

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


Condition Intervention Phase
Neonatal Sepsis
Drug: rh-GCSF
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Ain Shams University:

Primary Outcome Measures:
  • all cause mortality [ Time Frame: one month ] [ Designated as safety issue: No ]

Enrollment: 90
Study Start Date: April 2009
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   up to 4 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Rania Ali El-Farrash, Dr., Ain Shams University
ClinicalTrials.gov Identifier: NCT01479114     History of Changes
Other Study ID Numbers: MREC 09030
Study First Received: November 21, 2011
Last Updated: November 24, 2011
Health Authority: Egypt: Ministry of Health, Drug Policy and Planning Center

Additional relevant MeSH terms:
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014