Effectivness and Safety of Oral Bovine Lactoferrin in Neonatal Sepsis and Necrotizing Enterocolitis and Its Effect on Anaemia of Prematurity
Overview
- Phase
- Early Phase 1
- Intervention
- Lactoferrin
- Conditions
- Neonatal SEPSIS
- Sponsor
- Cairo University
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Change in mortality rate of neonatal sepsis in preterm neonate
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
ayman zaher
Resident of Pediatrics
Cairo University
Eligibility Criteria
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.
Arms & Interventions
lacoferrin
Pravotin is given orally 100 mg per sachet dissolved in 5 ml water given for one month
Intervention: Lactoferrin
placebo
saline is given orally in dose of 2 ml per day for one month
Intervention: Placebos
Outcomes
Primary Outcomes
Change in mortality rate of neonatal sepsis in preterm neonate
Time Frame: 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
Time Frame: one year
Neonates will be assessed for long term complication as necrotizing enterocolitis , retinoapathy of prematurity and bronchopulmonary dysplasia