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

NCT07480434 | Completed Phase 1

• 1 other identifier: 174
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis

Keywords

Clinical sepsis; Enteral Lactoferrin; Preterm neonates

Outcome Measures

Primary Outcomes (1)

• Neonatal Sepsis

  Neonatal Sepsis Score was used to assess clinical severity of sepsis

  7 Days

Study Arms (2)

Group A participants with standard treatment

NO INTERVENTION

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

EXPERIMENTAL

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.

Biological: Bovine Lactoferrin Supplement

Interventions

Bovine Lactoferrin Supplement BIOLOGICAL

Group B participants were given bovine lactoferrin orally at a dose of 150 mg/kg/day once within 72 hours of birth

Group B participants

Eligibility Criteria

• Age: Up to 37 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zartash Sial Paeds Med: lead

Study Sites (1)

King Edward Medical University Lahore

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 14, 2026
• First Posted: March 18, 2026
• Study Start: October 1, 2024
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)