Clinical Trial

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

Completed Phase 1
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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.
Trial Details
NCT Number NCT07480434
Lead Sponsor Zartash Sial Paeds Med
Conditions Sepsis
Enrollment 180 participants
Start Date 2024-10-01
Primary Completion 2025-03-31 (estimated)
Study Completion 2025-03-31 (estimated)
Updated on ClinicalTrials.gov 2026-03-18