Skip to content

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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07480434
Enrollment
180
Registered
2026-03-18
Start date
2024-10-01
Completion date
2025-03-31
Last updated
2026-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis

Keywords

Clinical sepsis, Enteral Lactoferrin, Preterm neonates

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.

Interventions

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

Sponsors

Zartash Sial Paeds Med
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
No minimum to 37 Weeks
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.

Design outcomes

Primary

MeasureTime frameDescription
Neonatal Sepsis7 DaysNeonatal Sepsis Score was used to assess clinical severity of sepsis

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026