drugset / Trial / NCT07480434

Role of Enteral Lactoferrin as an Adjuvant for Prevention of Sepsis Among Preterm Neonates

NCT07480434

Phase 1 Completed 180 enrolled Zartash Sial Paeds Med
RandomizedParallel-groupSingle-blindPrevention

Summary

Lactoferrin (LF) is a multifunctional glycoprotein and is naturally present in various body secretions, including human milk, tears, saliva, airway mucus, and the secondary granules of neutrophils 1-2. It plays a crucial role in innate infant immunity by exerting immunomodulatory, antimicrobial and anti-inflammatory effects. The biochemical and molecular properties of LF, such as ferric iron transport, enzymatic activity, and nuclear binding for transcriptional regulation, essentially make it a versatile defense molecule in host-pathogen interactions. Sepsis remains leading cause of morbidity and mortality in vulnerable populations , placing significant burdens on healthcare systems and families. Despite advancements in neonatal care, strategies to effectively reduce these risks remain limited, necessitating a focus on prophylactic interventions that are safe and evidence-based. This study is designed to fill the gaps of possible preventive strategy for sepsis among premature babies and to evaluate the effectiveness of enteral lactoferrin supplementation in decreasing the clinical sepsis among preterm neonates.

Timeline

Start
2024-10-01
Primary completion
2025-03-31
Completion
2025-03-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Lactoferrin Protein / enzyme biologic 150 mg/kg Oral