Safety and Efficacy of Oral Bovine Lactoferrin

Early Phase 1CompletedNCT04094597

Cairo University200 enrolled

Overview

Oral lactoferrin versus Placebo will be given to preterm neonates

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

200

Conditions

Neonatal SEPSIS

Interventions

LactoferrinDRUG

lactoferrin is given orally in comparsion to placebp

PlacebosDRUG

placebp is given in 2 ml saline

Eligibility

Sex: ALLMin age: 1 DayMax age: 7 DaysHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Ayman

Asyut, Assuit, Egypt

Outcomes

Primary Outcomes

Change in mortality rate of neonatal sepsis in preterm neonate

Neonates will be assessed by C-reactive protein and different cultures to identify Neonatal sepsis

Time frame: one year

Number of Preterm Neonates who will have long term Complication after one month of regular use of Lactoferrin

Neonates will be assessed for long term complication as necrotizing enterocolitis , retinoapathy of prematurity and bronchopulmonary dysplasia

Time frame: one year

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.