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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
Randomised controlled trial
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lactoferrin group | Experimental | Neonates who will receive oral lactoferrin supplementation. |
|
| Control | Other | who Will not receive |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactoferrin in prevention of VAP | Dietary 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment until day 28 of life or NICU discharge, whichever occurs first. |
| Prevention of VAP | Incidence of ventilator-associated pneumonia during mechanical ventilation. | during NICU stay |
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Inclusion Criteria:
Preterm neonates requiring mechanical ventilation.
Gestational age: (GA 28-36 weeks).
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neonatal Intensive Care Unit, Tanta University Children's Hospital | Tanta | Egypt |
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| ID | Term |
|---|---|
| D053717 | Pneumonia, Ventilator-Associated |
| ID | Term |
|---|---|
| D000077299 | Healthcare-Associated Pneumonia |
| D003428 | Cross Infection |
| D007239 | Infections |
| D011014 | Pneumonia |
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| ID | Term |
|---|---|
| D007781 | Lactoferrin |
| ID | Term |
|---|---|
| D012697 | Serine Endopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
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|
| Control | Other | They will receive standard preventive VAP strategies only. |
|
| D012141 |
| Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004798 |
| Enzymes |
| D045762 | Enzymes and Coenzymes |
| D057057 | Serine Proteases |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D061250 | Transferrins |
| D033862 | Iron-Binding Proteins |
| D002352 | Carrier Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D007782 | Lactoglobulins |
| D000067816 | Whey Proteins |
| D008894 | Milk Proteins |
| D000080224 | Animal Proteins, Dietary |
| D004044 | Dietary Proteins |
| D005916 | Globulins |
| D008667 | Metalloproteins |