NCT07480434

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: Zartash Sial Paeds Med · Academic / Other
• Sex: All
• Age: 37 Weeks
• Healthy volunteers: Not accepted

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.

Conditions

• Sepsis

Interventions

Type	Name	Description
BIOLOGICAL	Bovine Lactoferrin Supplement	Group B participants were given bovine lactoferrin orally at a dose of 150 mg/kg/day once within 72 hours of birth

Timeline

• Start date: 2024-10-01
• Primary completion: 2025-03-31
• Completion: 2025-03-31
• First posted: 2026-03-18
• Last updated: 2026-03-18

Locations

1 site across 1 country: Pakistan