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Completed

NCT Number: NCT01479114

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

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

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Key information

Conditions

Neonatal SEPSIS Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant, Newborn, Diseases Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Age range

Up to 4 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

rh-GCSF

Drug

10 ug/kg/day intravenously for 3 days

Other names: Granulocyte colony stimulating factor,neubogen,filgstrim

Primary outcomes

  1. all cause mortality

    Time frame: one month

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Nov 24, 2011
Registry last updated
Nov 28, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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