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Safety and Efficacy of Oral Bovine Lactoferrin

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

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04094597
Acronym
Lactoferrin
Enrollment
200
Registered
2019-09-19
Start date
2018-01-01
Completion date
2019-03-02
Last updated
2019-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal SEPSIS

Keywords

lactoferrin

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.

Interventions

DRUGLactoferrin

lactoferrin is given orally in comparsion to placebp

DRUGPlacebos

placebp is given in 2 ml saline

Sponsors

Kasr El Aini Hospital
CollaboratorOTHER
Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)

Masking description

Follow up of the patients with CRP and different cultures.

Intervention model description

placebo group 100 patient will receive 2 ml saline for one month in comparison with oral lactoferrin for the same period to another 100 patient

Eligibility

Sex/Gender
ALL
Age
1 Days to 7 Days
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in mortality rate of neonatal sepsis in preterm neonateone yearNeonates 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 Lactoferrinone yearNeonates will be assessed for long term complication as necrotizing enterocolitis , retinoapathy of prematurity and bronchopulmonary dysplasia

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026