Lactoferrin to help prevent infections in ventilated newborns

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized controlled trial investigates the preventive use of lactoferrin in neonates who require mechanical ventilation. It compares lactoferrin to a control to see if it reduces the incidence of ventilator-associated pneumonia, sepsis, feeding intolerance, vomiting, constipation or diarrhea, and impacts duration of ventilation and hospital stay. The study targets critically ill neonates without major congenital conditions, and excludes those with early proven sepsis or significant gastrointestinal disease. Outcomes include both the primary effect on VAP and secondary effects on clinical course. Conducted at a neonatal intensive care unit in a university hospital setting, with the lead sponsor and no listed collaborators beyond the site.

Why it matters

Who can join: the full rules

Inclusion Criteria:

neonates requiring mechanical ventilation.

Gestational age:

Expected need for mechanical ventilation for ≥ (48hours)

Exclusion Criteria:

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.

Where it's running

• Neonatal Intensive Care Unit, Tanta University Children's Hospital
  Tanta, Egypt Recruiting

Study contacts

• Study coordinator: Dalia Ayoub
• Email: dalia.ayoub@med.tanta.edu.eg
• Phone: +201066343989

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.