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OpenTrials
Completed

NCT Number: NCT07480434

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

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.

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Key information

Age range

Up to 37 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

King Edward Medical University Lahore

Lahore, Punjab Province, 54000, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Neonatal Sepsis

    Time frame: 7 Days

    Neonatal Sepsis Score was used to assess clinical severity of sepsis

Sponsors and collaborators

Lead sponsor

Zartash Sial Paeds Med

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 18, 2026
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.