Effect of recombinant granulocyte-colony-stimulating factor on early onset sepsis

A randomized double-masked placebo-controlled trial of recombinant granulocyte-colony-stimulating factor administration to AGA pre term newborn with clinically presumed diagnosis of early onset sepsis admitted to NICU ward of Ghaem hospital

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20190109042311N1

Enrollment

Registered

2019-01-29

Start date

2011-06-01

Completion date

Unknown

Last updated

2019-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early onset neonatal sepsis. Other sepsis

Interventions

Intervention 1: Intervention group: 10 µg/kg/day of rhG-CSF in dextrose 5% over 20-40 min for three consecutive days, intravenous infusions. All infants also received routine sepsis care including ant

Eligibility

Sex/Gender

All

Age

1 Days to 28 Days

Inclusion criteria

Inclusion criteria: Diagnosis of sepsis Gestational age (GA) below 35 weeks (Range 30-35 weeks) Birth weight less than 2000 g Presence of bacteria in the blood culture and infection signs in the first 3 days of life verified early-onset neonatal sepsis Clinical presentation of infection in the absence of positive blood culture verified clinical sepsis in preterm infants Sufficient renal and liver functions Infant age between 1 and 28 days

Exclusion criteria

Exclusion criteria: APGAR score less than five at five minutes Major congenital anomaly Severe birth asphyxia (hypoxic-ischemic encephalopathy) Maternal severe preeclampsia unresponsive to medical therapy Systemic hypotension or metabolic disorders Absolute neutrophil count (ANC) greater than 6,000/µL Severe lesions like intraventricular hemorrhage with grade III and IV

Design outcomes

Primary

Measure	Time frame
White blood cells count (WBC). Timepoint: At baseline before the study commencement and 3 days after of recombinant granulocyte-colony-stimulating factor administration. Method of measurement: Hemocytometer.	—

Secondary

Measure	Time frame
Absolute neutrophil count (ANC). Timepoint: At baseline before the study commencement and 3 days after of recombinant granulocyte-colony-stimulating factor administration. Method of measurement: The ANC was measured by examining the blood smears under light microscope.;Serum level of hs-CRP. Timepoint: At baseline before the study commencement and 3 days after of recombinant granulocyte-colony-stimulating factor administration. Method of measurement: The serum high-sensitivity CRP (hs-CRP) was evaluated by using a sensitive CRP assay (Monobind, INC. Lake Forest, USA).;Ratio of immature to total neutrophils. Timepoint: At baseline before the study commencement and 3 days after of recombinant granulocyte-colony-stimulating factor administration. Method of measurement: Ratio of immature to total neutrophils was measured by examining the blood smears under light microscope.;Mortality rate. Timepoint: At the ends of the study (day 3). Method of measurement: The neonatal hospital mortality rate refers to the number of deaths reported in hospitalized newborns over a given period expressed as a percentage.;Duration of hospital stay. Timepoint: At the ends of the study (day 3). Method of measurement: The difference between date/time of admission and date/time of discharge, described as hours.	—

Measure

Time frame

Absolute neutrophil count (ANC). Timepoint: At baseline before the study commencement and 3 days after of recombinant granulocyte-colony-stimulating factor administration. Method of measurement: The ANC was measured by examining the blood smears under light microscope.;Serum level of hs-CRP. Timepoint: At baseline before the study commencement and 3 days after of recombinant granulocyte-colony-stimulating factor administration. Method of measurement: The serum high-sensitivity CRP (hs-CRP) was evaluated by using a sensitive CRP assay (Monobind, INC. Lake Forest, USA).;Ratio of immature to total neutrophils. Timepoint: At baseline before the study commencement and 3 days after of recombinant granulocyte-colony-stimulating factor administration. Method of measurement: Ratio of immature to total neutrophils was measured by examining the blood smears under light microscope.;Mortality rate. Timepoint: At the ends of the study (day 3). Method of measurement: The neonatal hospital mortality rate refers to the number of deaths reported in hospitalized newborns over a given period expressed as a percentage.;Duration of hospital stay. Timepoint: At the ends of the study (day 3). Method of measurement: The difference between date/time of admission and date/time of discharge, described as hours.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Abbas Shapouri-Moghaddam

Mashhad University of Medical Sciences

shapourima@mums.ac.ir+98 51 3846 5990

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026