G-CSF In Neonatal Sepsis With Neutropenia

Neonatal Sepsis, Neutropenia

G-CSF, Neutrophil Count, Sepsis Treatment, Granulocyte-Colony Stimulating Factor, Neonatal Sepsis, Anti-Infective Agents

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.

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Pakistan