SepsisPhase 1NCT07480434
Role of Enteral Lactoferrin as an Adjuvant for Prevention of Sepsis Among Preterm Neonates
A Phase 1 study testing Bovine Lactoferrin Supplement in people with Sepsis, run by Zartash Sial Paeds Med at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 37 weeks
- Conditions the study is for
- Sepsis
- What is being tested?
- Bovine Lactoferrin Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Oct 2024to 31 Mar 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 37 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
King Edward Medical University Lahore
Lahore, Punjab Province, 54000
About this study
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
- Being tested
- Bovine Lactoferrin Supplement
- Keywords
- Clinical sepsis, Enteral Lactoferrin, Preterm neonates
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bovine Lactoferrin SupplementBiological
Group B participants were given bovine lactoferrin orally at a dose of 150 mg/kg/day once within 72 hours of birth
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Bovine Lactoferrin Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal Sepsis
Neonatal Sepsis Score was used to assess clinical severity of sepsis
Measured: 7 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start1 Oct 2024
- Primary completion31 Mar 2025
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zartash Sial Paeds Med
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zartash Sial Paeds Med, King Edward Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07480434
- Sponsor's protocol ID
- 174
- Status last verified
- Mar 2026
- First submitted
- 14 Mar 2026
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Enteral Lactoferrin as an Adjuvant for Prevention of Sepsis Among Preterm Neonates
- ClinicalTrials.gov ID
- NCT07480434
- Acronym / sponsor ID
- 174
- Conditions
- Sepsis
- Keywords
- Clinical sepsis, Enteral Lactoferrin, Preterm neonates
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Zartash Sial Paeds MedUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 18 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Biological: Bovine Lactoferrin SupplementPreterm 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. |
Who may qualify
- Ages
- Up to 37 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bovine Lactoferrin SupplementGroup B participants were given bovine lactoferrin orally at a dose of 150 mg/kg/day once within 72 hours of birth | Biological | Group B participants |
Primary outcome
Neonatal Sepsis
Time frame: 7 Days
Neonatal Sepsis Score was used to assess clinical severity of sepsis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Sepsis
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Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bovine Lactoferrin Supplement in people with Sepsis, run by Zartash Sial Paeds Med at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neonatal Sepsis (time frame: 7 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.