Oral Lactoferrin Supplementation for Prevention of Sepsis in Preterm Neonate
NCT ID: NCT01821989
Last Updated: 2014-05-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
EARLY_PHASE1
180 participants
INTERVENTIONAL
2013-06-30
Brief Summary
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Orally ingested lactoferrin has effects on promotion of growth and differentiation of the immature gut; also it has immunomodulatory properties, so it will prevent serious infections in preterm infants.
The aim of the study is to:
* Evaluate the effectiveness of oral lactoferrin in prevention of neonatal sepsis.
* Compare two dose regiment of lactoferrin supplementation.
* Study effect of lactoferrin supplementation on serum iron stores.
It is a prospective, randomized, double blind, placebo-controlled study, it will include 180 preterm neonates admitted to the Neonatal Intensive Care Units of of Ain Shams University Hospitals and Manshiet El Bakry Hospital.
•Group A: Who will receive oral lactoferrin supplementation in a dose of 100 mg/day.
•Group B: Who will receive oral lactoferrin supplementation in a dose of 150 mg/kg/ twice daily.
•Group C (Controls): Who match the subjected neonates, will receive placebo in form of distilled water.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Low Dose
Lactoferrin,dose of 100 mg/day.
Lactoferrin
dose of 100 mg/day
High Dose
Lactoferrin, dose of 150 mg/kg/ twice daily.
Lactoferrin
dose of 150 mg/kg/ twice daily
Control
Receive placebo in form of distilled water.
Placebo
in form of distilled water
Interventions
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Lactoferrin
dose of 100 mg/day
Lactoferrin
dose of 150 mg/kg/ twice daily
Placebo
in form of distilled water
Eligibility Criteria
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Inclusion Criteria
2. Neonates with a ≤ 36 weeks of gestation counting from the first day of the Last Menstrual Period.
3. Preterm neonates born in, or referred to the Neonatal Intensive Care Units of one of the participating hospitals in the first 48 hours of life.
Exclusion Criteria
2. Neonates with predisposing conditions that profoundly affect growth and development (chromosomal abnormalities, structural brain anomalies, severe congenital abnormalities).
3. Neonates with a family background of cow milk allergy.
4. Neonates who will not have the chance to complete the study time (who will be referred to another hospitals).
5. Neonates whose parents decline to participate.
6. Neonates with early onset sepsis.
28 Days
ALL
Yes
Sponsors
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Mooselmokadem
OTHER
Responsible Party
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Mostafa El-Mokadem
neonatologist
Locations
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Ain Shams University
Cairo, Abassia, Egypt
Countries
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Central Contacts
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Other Identifiers
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moos80
Identifier Type: -
Identifier Source: org_study_id
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