An interventional study of Granulocyte-colony stimulating factor (G-CSF) and Standard Sepsis Management in Neonatal Sepsis and Neutropenia, sponsored by University of Health Sciences Lahore. Not yet recruiting at 1 site in Pakistan. Open to participants aged 0 Days to 28 Days. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by University of Health Sciences Lahore · Not applicable, Interventional, and Treatment
This study will evaluate whether adding G-CSF to standard treatment improves outcomes in newborns (0-28 days) with sepsis and neutropenia. It will compare survival, recovery of neutrophil counts, hospital stay, infections, and adverse effects between babies receiving G-CSF and standard treatment alone.
This randomized controlled trial will evaluate the effectiveness of granulocyte-colony stimulating factor (G-CSF) as an adjuvant treatment in neonates with sepsis and neutropenia.
Neonatal sepsis is a clinical syndrome occurring during the first 28 days of life in which infection is associated with a systemic inflammatory response. In this study, neonatal sepsis will be identified on the basis of clinical features and laboratory findings, including signs of systemic inflammatory response syndrome (SIRS), positive blood, urine, or tracheal secretion cultures and/or elevated C-reactive protein (CRP). SIRS is defined by the presence of at least two specified criteria involving body temperature, heart rate, respiratory rate or PaCO2, and leukocyte count. Neutropenia is defined as an absolute neutrophil count (ANC) below 1500/µL.
G-CSF is a glycoprotein that promotes the growth, survival, and differentiation of neutrophils and enhances their antimicrobial activity. The study is based on the rationale that neutropenia in neonates with sepsis may be associated with poorer treatment outcomes because of limited neutrophil reserves and impaired recovery of neutrophil production. Increasing neutrophil counts through G-CSF administration may therefore improve the clinical course of affected neonates.
The study will be conducted in the Department of Neonatology at The Children's Hospital/The University of Child Health Sciences, Lahore, Pakistan. The planned study duration is at least six months after approval of the study synopsis.
A total of 52 neonates will be enrolled and divided into two groups of 26 participants each. The intervention group will receive standard sepsis management plus G-CSF at a dose of 10 µg/kg/day administered subcutaneously for three days. The control group will receive standard sepsis management alone. ANC will be monitored daily.
Eligible participants will be neonates aged 0-28 days admitted to the Department of Neonatology who meet the study definition of sepsis and have an ANC below 1500/µL. Neonates with congenital anomalies, birth asphyxia, primary immunodeficiency, or previous treatment with colony-stimulating factor or another adjuvant therapy will be excluded.
Data will be collected using a study proforma. Baseline clinical and laboratory information will be recorded, including gestational age, birth weight, clinical signs, blood culture results, complete blood count, ANC, CRP and other relevant laboratory findings. Following treatment, hematological parameters and clinical outcomes will be monitored.
The primary purpose of the study is to assess whether G-CSF improves clinical outcomes in neonates with sepsis and neutropenia. Outcomes assessed will include mortality, duration of neutropenia, duration of hospital stay, frequency of healthcare-associated infections, and adverse effects. Healthcare-associated infections assessed in the study include catheter-associated urinary tract infection, central-line-associated bloodstream infection, and ventilator-associated pneumonia.
The study will compare outcomes between neonates receiving standard sepsis management with G-CSF and those receiving standard sepsis management alone. Quantitative variables will be summarized using appropriate descriptive statistics, while qualitative variables will be presented as frequencies and percentages. Statistical comparisons will be performed using the planned statistical tests, with a p-value below 0.05 considered statistically significant.
The study is intended to determine whether G-CSF provides an additional clinical benefit when used alongside standard treatment in neonates with sepsis and neutropenia. Its findings may provide evidence to guide clinicians and inform future management of this high-risk neonatal population.
186 studies on the registry are indexed under Neonatal Sepsis; 42 are open to participants now.
This study's planned enrollment of 52 is below the median of 180 across 97 interventional studies indexed under Neonatal Sepsis.
Browse Neonatal Sepsis studies →University of Health Sciences Lahore is the lead sponsor of 80 studies on the registry; 50 are open to participants now.
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Exclusion Criteria:
This group consists of 26 neonates with sepsis and neutropenia who receive G-CSF in addition to standard sepsis management.
Biological: Granulocyte-colony stimulating factor (G-CSF)
This group consists of 26 neonates with sepsis and neutropenia who receive standard sepsis management without G-CSF.
Biological: Standard Sepsis Management
Drug pages: Granulocyte Colony-Stimulating Factor · Filgrastim
Granulocyte-colony stimulating factor (G-CSF) will be administered to neonates with sepsis and neutropenia. G-CSF will be given at a dose of 10 µg/kg/day. The drug will be administered subcutaneously for 3 consecutive days. G-CSF will be given in addition to standard sepsis management. The intervention group consists of 26 neonates.
Neonates in the control group will receive standard sepsis management for the treatment of neonatal sepsis and neutropenia. No G-CSF will be administered to this group. The control group consists of 26 neonates. Outcomes will be monitored and recorded during the study. These include mortality, duration of neutropenia, duration of hospital stay, healthcare-associated infections, and adverse effects.
Mortality
Mortality among neonates with sepsis and neutropenia will be compared between the intervention group receiving G-CSF plus standard sepsis management and the control group receiving standard sepsis management alone.
Time frame: From enrollment until discharge or death, within the first 28 days of life
Change in Absolute Neutrophil Count (ANC)
The absolute neutrophil count (ANC) will be measured before and after G-CSF administration to assess improvement in neutrophil count among neonates with sepsis and neutropenia.
Time frame: Baseline through Day 3 (daily assessments during the 3-day treatment period)
Duration of Neutropenia
Duration of neutropenia will be assessed in neonates with sepsis and neutropenia and compared between the intervention and control groups. Neutropenia is defined as an absolute neutrophil count below 1500/µL.
Time frame: From enrollment through hospital discharge, up to 28 days of life
Duration of Hospital Stay
The duration of hospitalization will be recorded for neonates in the intervention and control groups and compared to determine whether addition of G-CSF is associated with a shorter hospital stay.
Time frame: From enrollment through hospital discharge, up to 28 days of life
Frequency of Healthcare-Associated Infections
The frequency of healthcare-associated infections will be recorded and compared between the intervention and control groups. Healthcare-associated infection is defined as a new episode of infection occurring ≥72 hours after G-CSF administration in a neonate initially admitted with sepsis and neutropenia.
Time frame: From enrollment through hospital discharge, up to 28 days of life
Catheter-Associated Urinary Tract Infection (CAUTI)
The occurrence of catheter-associated urinary tract infection will be recorded in neonates in both study groups and compared between the intervention and control groups during hospitalization.
Time frame: From enrollment through hospital discharge, up to 28 days of life
Central Line-Associated Bloodstream Infection (CLABSI)
The occurrence of central line-associated bloodstream infection will be recorded in neonates in both study groups and compared between the intervention and control groups during hospitalization.
Time frame: From enrollment through hospital discharge, up to 28 days of life
Ventilator-Associated Pneumonia (VAP)
The occurrence of ventilator-associated pneumonia will be recorded in neonates in both study groups and compared between the intervention and control groups during hospitalization.
Time frame: From enrollment through hospital discharge, up to 28 days of life
Plan to share: No
Start is estimated for Feb 2027; primary completion for Mar 2027, 1 month later.
Of 30 interventional studies with no phase under Neonatal Sepsis, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 35. This study's planned 1 month is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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University of Health Sciences Lahore