Safety and Efficacy of Oral Bovine Lactoferrin

Neonatal SEPSIS Clinical Trial

— Lactoferrin  

Official title:

Effectivness and Safety of Oral Bovine Lactoferrin in Neonatal Sepsis and Necrotizing Enterocolitis and Its Effect on Anaemia of Prematurity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04094597
• Other study ID #: Abu Elrich children hospital
• Secondary ID: 01525316
• Status: Completed
• Phase: Early Phase 1
• Start date: January 1, 2018
• Est. completion date: March 2, 2019

Study information

• Verified date: September 2019
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Oral lactoferrin versus Placebo will be given to preterm neonates

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 information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: March 2, 2019
• Est. primary completion date: December 28, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 7 Days

Eligibility

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.

Related Conditions & MeSH terms

• Neonatal SEPSIS
• Sepsis

Intervention

Drug:
• Lactoferrin
lactoferrin is given orally in comparsion to placebp
• Placebos
placebp is given in 2 ml saline

Locations

Country	Name	City	State
Egypt	Ayman	Assiut	Assuit

Sponsors (2)

Lead Sponsor	Collaborator
Cairo University	Kasr El Aini Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	one year
Primary	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	one year

External Links

•   lactoferrin