Lactoferrin
DrugOther names: Bovine Lactoferrin
NCT Number: NCT02959229
The present study was designed to evaluate the effectiveness of oral lactoferrin in prevention of neonatal sepsis with comparison early (1st day) versus late (48-72 hours) Lactoferrin administration, Secondary aim was to study effect of Lactoferrin administration on serum Ferritin and follow up long term outcome (Bronchopulmonary dysplasia, retinopathy of prematurity and necrotizing enterocolitis.
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All sexes
Interventional
Phase 4
This study was carried out on 180 preterm neonates(< 37 weeks of gestation counting from the first day of the Last Menstrual Period and confirmed by Ballard score) admitted to the Neonatal Intensive Care Units of Ain Shams University Hospitals in the period from August 2014 to December 2015.
Enrolled subjects were further randomly subdivided into three groups according to the dose regimen of Lactoferrin supplementation.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Other names: Bovine Lactoferrin
placebo in form of distilled water
Time frame: 4-6 weeks of life
Time frame: 4-6 weeks of life
Time frame: 4-6 weeks of life
Long term complications as:
Broncho-Pulmonary Dysplasia using clinical symptoms and signs and chest X ray findings.
Retinopathy of Prematurity using the International Classification of Retinopathy of Prematurity (ICROP).
Necrotizing Enterocolitis using Modified Bell's criteria for staging Necrotizing Enterocolitis.
Time frame: 4-6 weeks of life
Ain Shams University
Other
Systematic Randomized , Single Blinded, Placebo-Controlled Trial of Early Versus Late Lactoferrin in Prevention of Neonatal Sepsis
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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