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

NCT ID: NCT01479114

Last Updated: 2011-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2010-05-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Neonatal Sepsis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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control group

Group Type NO_INTERVENTION

No interventions assigned to this group

G-CSF group

Group Type EXPERIMENTAL

rh-GCSF

Intervention Type DRUG

10 ug/kg/day intravenously for 3 days

Non-GCSF group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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rh-GCSF

10 ug/kg/day intravenously for 3 days

Intervention Type DRUG

Other Intervention Names

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Granulocyte colony stimulating factor,neubogen,filgstrim

Eligibility Criteria

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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
Maximum Eligible Age

4 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Rania Ali El-Farrash

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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MREC 09030

Identifier Type: -

Identifier Source: org_study_id