Safety and Efficacy of Oral Bovine Lactoferrin
- Registration Number
- NCT04094597
- Lead Sponsor
- Cairo University
- Brief Summary
Oral lactoferrin versus Placebo will be given to preterm neonates
- Detailed Description
200 patient were included in the study , one hundred received oral placebo in the form of 2 ml saline , the other 100 preterm neonates received oral lactoferrin with monitoring of C-reactive protein , different cultures, complete blood count on day 7 and after one month.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
All neonates born at Cairo university hospital NICU
Exclusion Criteria
- Neonatal deaths before 3 days postnatal .
- Neonates with underlying gastrointestinal problems that prevent oral intake.
- Neonates with major congenital anomalies .
- Neonates with severe hypoxic ischemic encephaloapathy .
- Neonates whose parents refuse to participate.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo Placebos saline is given orally in dose of 2 ml per day for one month lacoferrin Lactoferrin Pravotin is given orally 100 mg per sachet dissolved in 5 ml water given for one month
- Primary Outcome Measures
Name Time Method Change in mortality rate of neonatal sepsis in preterm neonate one year Neonates will be assessed by C-reactive protein and different cultures to identify Neonatal sepsis
Number of Preterm Neonates who will have long term Complication after one month of regular use of Lactoferrin one year Neonates will be assessed for long term complication as necrotizing enterocolitis , retinoapathy of prematurity and bronchopulmonary dysplasia
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Ayman
🇪🇬Assiut, Assuit, Egypt