Ventilator Associated PneumoniaNCT07255742
Role of Lactoferrin in Prevention of Ventilator Associated Pneumonia in Neonates.
A study testing Lactoferrin in prevention of VAP in people with Ventilator Associated Pneumonia, run by Dalia Mohamed Salah at 1 site in Egypt.
Trial summary
The aim of the study is to 1. Evaluate the preventive value of Lactoferrin on VAP among ventilated neonates. 2. Evaluate the Primary outcome of Lactoferrin on: Sepsis, Feeding intolerance, Vomiting, Constipation or diarrhea 3. Read more about this study
- Who is it for?
- Ages 0 to 90 days
- Conditions the study is for
- Ventilator Associated Pneumonia
- What is being tested?
- Lactoferrin in prevention of VAP
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2025to 1 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 0 to 90 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- neonates requiring mechanical ventilation.
- Gestational age:
- Expected need for mechanical ventilation for ≥ (48hours)
Who cannot join
- Congenital anomalies of the lung or airway.
- Major congenital heart disease.
- Proven early-onset sepsis at enrollment.
- Severe perinatal asphyxia (e.g., Apgar < 3 at 5 minutes or seizures).
- Known contraindication or allergy to lactoferrin.
- Severe gastrointestinal pathology (e.g., NEC stage II or higher).
- Any condition deemed by the clinical team to interfere with study participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Neonatal Intensive Care Unit, Tanta University Children's Hospital
Tanta
About this study
The aim of the study is to
- Evaluate the preventive value of Lactoferrin on VAP among ventilated neonates.
- Evaluate the Primary outcome of Lactoferrin on: Sepsis, Feeding intolerance, Vomiting, Constipation or diarrhea
- Evaluate the effect of Lactoferrin in critically ventilated neonates on:
Incidence of VAP Duration of mechanical ventilation Duration of hospital stay
Read the detailed description
Randomised controlled trial
- Conditions
- Ventilator Associated Pneumonia
- Being tested
- Lactoferrin in prevention of VAP, Control
- Keywords
- Lactoferrin,VAP
- Medical subject headings
- Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactoferrin in prevention of VAPDietary supplement
oral dose separate from feeds [at a daily dose of 100mg/day] via orogastric tube from first day of enrollment till time of successful extubation plus standard preventive measures of VAP; these include semi recumbent position, hand washing, suctioning when needed, endotracheal tube with subglottic secretion drainage, using heat and moisture exchanger filter, oral hygiene, changing of tubes only when needed and changing of ventilator circuit every 5 days.
ControlOther
They will receive standard preventive VAP strategies only.
| Study group | Role | What they receive |
|---|---|---|
| Lactoferrin group | Experimental | Neonates who will receive oral lactoferrin supplementation. Receives: Dietary Supplement: Lactoferrin in prevention of VAP |
| Control | Other | who Will not receive Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevention of VAP
Diagnosis of VAP using the CDC/NHSN clinical and radiological criteria for neonatal ventilator-associated events. Outcome measured as the percentage (%) of enrolled neonates who develop VAP during NICU stay or up to 28 days of life.
Measured: From enrollment until day 28 of life or NICU discharge, whichever occurs first.
Prevention of VAP
Incidence of ventilator-associated pneumonia during mechanical ventilation.
Measured: during NICU stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2025
- Study start1 Aug 2025
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator Associated PneumoniaStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dalia Mohamed Salah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dalia Mohamed Salah, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07255742
- Sponsor's protocol ID
- 36264PR702/5/24
- Status last verified
- Nov 2025
- First submitted
- 16 Nov 2025
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Lactoferrin in Prevention of Ventilator Associated Pneumonia in Neonates.
- ClinicalTrials.gov ID
- NCT07255742
- Acronym / sponsor ID
- 36264PR702/5/24
- Conditions
- Ventilator Associated Pneumonia
- Keywords
- Lactoferrin,VAP
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Dalia Mohamed SalahUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 1 Dec 2025 (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.
The aim of the study is to
- Evaluate the preventive value of Lactoferrin on VAP among ventilated neonates.
- Evaluate the Primary outcome of Lactoferrin on: Sepsis, Feeding intolerance, Vomiting, Constipation or diarrhea
- Evaluate the effect of Lactoferrin in critically ventilated neonates on:
Incidence of VAP Duration of mechanical ventilation Duration of hospital stay
Detailed description
Randomised controlled trial
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactoferrin group | Experimental | Dietary Supplement: Lactoferrin in prevention of VAPNeonates who will receive oral lactoferrin supplementation. |
| Control | Other | Other: Controlwho Will not receive |
Who may qualify
- Ages
- 0 to 90 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- neonates requiring mechanical ventilation.
- Expected need for mechanical ventilation for ≥ (48hours)
Key exclusion criteria (7 listed)
- Congenital anomalies of the lung or airway.
- Major congenital heart disease.
- Proven early-onset sepsis at enrollment.
- Severe perinatal asphyxia (e.g., Apgar < 3 at 5 minutes or seizures).
- Known contraindication or allergy to lactoferrin.
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 |
|---|---|---|
| Lactoferrin in prevention of VAPoral dose separate from feeds [at a daily dose of 100mg/day] via orogastric tube from first day of enrollment till time of successful extubation plus standard preventive measures of VAP; these include semi recumbent position, hand washing, suctioning when needed, endotracheal tube with subglottic secretion drainage, using heat and moisture exchanger filter, oral hygiene, changing of tubes only when needed and changing of ventilator circuit every 5 days. | Dietary supplement | Lactoferrin group |
| ControlThey will receive standard preventive VAP strategies only. | Other | Control |
Primary outcome
Prevention of VAP
Time frame: From enrollment until day 28 of life or NICU discharge, whichever occurs first.
Diagnosis of VAP using the CDC/NHSN clinical and radiological criteria for neonatal ventilator-associated events. Outcome measured as the percentage (%) of enrolled neonates who develop VAP during NICU stay or up to 28 days of life.
Prevention of VAP
Time frame: during NICU stay
Incidence of ventilator-associated pneumonia during mechanical ventilation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactoferrin in prevention of VAP in people with Ventilator Associated Pneumonia, run by Dalia Mohamed Salah at 1 site in Egypt.
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 3 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 6 Oct 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 Egypt. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dalia Ayoub (+201066343989, dalia.ayoub@med.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevention of VAP (time frame: From enrollment until day 28 of life or NICU discharge, whichever occurs first.). The study lists 2 primary outcomes in all. 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 6 Oct 2026.