G-CSF in treatment of premature neonates with neutropenia and clinical sepsis

Evaluation of G-CSF efficacy in treatment of premature neonates with neutropenia and clinical sepsis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT201303252639N11

Enrollment

Registered

2013-04-04

Start date

2012-09-22

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

neonatal sepsis. Other infectious diseases

Interventions

Intervention 1: subcutaneous GCSF in dosage of 10 µg / kg / day for 5 consecutive days. Intervention 2: normal saline subcutaneously.

Treatment - Drugs

subcutaneous GCSF in dosage of 10 µg / kg / day for 5 consecutive days

normal saline subcutaneously

Eligibility

Sex/Gender

All

Age

No minimum to 1 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: 1- Gestational age of 30-37 weeks 2- Age of less than 10 days 3- Total neutrophil count = 5000 in µL 4- The neonate has sepsis based on clinical criteria Exclusion criteria: 1- Severe asphyxia 2- Life threatening congenital malformations 3- Total leukocytes count = 20.000 in µL 4- Intraventricular hemorrhage grade 3 or 4 5- Thrombocytopenia ( platelets less than 150000 in µL) 6- Anemia ( Hemoglobin=10g/dL) 7- Metabolic acidosis (PH = 7.2)

Exclusion criteria

Exclusion criteria:

Design outcomes

Secondary

Measure	Time frame
Confirmed documented sepsis by cultures. Timepoint: at the end of fourteenth day of the study. Method of measurement: based on results of cultures.;Occurrence of abdominal distension. Timepoint: continuously. Method of measurement: clinical examination.;Fever occurrence and its duration. Timepoint: continuously. Method of measurement: clinical examination.;Thrombocytopenia. Timepoint: daily. Method of measurement: laboratory.	—

Measure

Time frame

Confirmed documented sepsis by cultures. Timepoint: at the end of fourteenth day of the study. Method of measurement: based on results of cultures.;Occurrence of abdominal distension. Timepoint: continuously. Method of measurement: clinical examination.;Fever occurrence and its duration. Timepoint: continuously. Method of measurement: clinical examination.;Thrombocytopenia. Timepoint: daily. Method of measurement: laboratory.

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Primary

Measure	Time frame
Oxygen dependency. Timepoint: continuously. Method of measurement: pulse oximetery.;Need to mechanical ventilation. Timepoint: continuously. Method of measurement: pulse oximetery.;Amount of tolerated feeding. Timepoint: daily. Method of measurement: clinical exam.;Mortality. Timepoint: continuously. Method of measurement: clinical exam.;Side effects of injection. Timepoint: continuously. Method of measurement: clinical exam.	—

Measure

Time frame

Oxygen dependency. Timepoint: continuously. Method of measurement: pulse oximetery.;Need to mechanical ventilation. Timepoint: continuously. Method of measurement: pulse oximetery.;Amount of tolerated feeding. Timepoint: daily. Method of measurement: clinical exam.;Mortality. Timepoint: continuously. Method of measurement: clinical exam.;Side effects of injection. Timepoint: continuously. Method of measurement: clinical exam.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr.Lila Borjian

Shahid Sadoughi University of Medical Sciences, Yazd, Iran

leila1890@yahoo.com+98 35 1822 4000

Outcome results

None listed

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