Role of Enteral Lactoferrin as an Adjuvant for Prevention of Sepsis Among Preterm Neonates
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- Neonatal Sepsis
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- — to 37 Weeks (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Preterm Neonates (Neonates who are born before the completion of 37 weeks of pregnancy)
- •Low birth weight infants less than 2500 grams at birth
- •Recruited within the first 72 hours after birth
- •Admitted to the Neonatology department
Exclusion Criteria
- •Neonates born with congenital anomalies
- •Newborns with infections identified at the time of birth, signs of infection on admission (fever, respiratory problems, etc.), or infection detected by the physician.
Arms & Interventions
Group A participants with standard treatment
Preterm neonates admitted to the neonatology department during the study period were randomly allocated into two groups. Group A is control group with standard treatment only
Group B participants
Preterm neonates admitted to the neonatology department during the study period were randomly allocated into two groups. In Group B bovine lactoferrin was given orally at a dose of 150 mg/kg/day once within 72 hours of birth.
Intervention: Bovine Lactoferrin Supplement (Biological)
Outcomes
Primary Outcomes
Neonatal Sepsis
Time Frame: 7 Days
Neonatal Sepsis Score was used to assess clinical severity of sepsis
Secondary Outcomes
No secondary outcomes reported
Investigators
Zartash Sial Paeds Med
Principal Investigator
King Edward Medical University