Completed

Enteral Lactoferrin Supplementation for Sepsis Prevention in Preterm Neonates

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Study Aim

This study aims to evaluate if enteral lactoferrin supplementation can prevent sepsis in preterm newborns, using the Neonatal Sepsis Score to assess the severity of sepsis.

What is being tested

Bovine Lactoferrin Supplement

Biological
Who is being recruted

Infections+3

+ Inflammation

+ Pathologic Processes

+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Phase 1
Interventional
Study Start: October 2024
See protocol details

Summary

Principal SponsorZartash Sial Paeds Med
Last updated: March 19, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2024

Actual date on which the first participant was enrolled.

This study focuses on the role of Lactoferrin (LF), a natural protein found in human milk and other body secretions, in helping to prevent sepsis in premature babies. Sepsis is a serious condition that remains a leading cause of illness and death in vulnerable populations, including preterm neonates. Despite improvements in neonatal care, ways to effectively reduce the risk of sepsis are still limited. This research aims to explore the potential of LF as a safe and evidence-based preventive strategy, given its immunomodulatory, antimicrobial, and anti-inflammatory effects. In this study, participants receive Lactoferrin as a supplement. The effectiveness of this supplementation is evaluated by measuring the clinical severity of sepsis using a Neonatal Sepsis Score. This score helps to assess the impact of LF on the baby's health, providing insights into its potential as a preventive measure against sepsis in premature infants.

Official TitleRole of Enteral Lactoferrin as an Adjuvant for Prevention of Sepsis Among Preterm Neonates
NCT07480434
Principal SponsorZartash Sial Paeds Med
Last updated: March 19, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

180 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

InfectionsInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsSystemic Inflammatory Response SyndromeSepsis

Criteria

4 inclusion criteria required to participate
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
2 exclusion criteria prevent from participating
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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

King Edward Medical University Lahore

Lahore, PakistanOpen King Edward Medical University Lahore in Google Maps
CompletedOne Study Center