Back to resultsSafety and Efficacy of Oral Bovine Lactoferrin (Lactoferrin)
Primary Purpose
Neonatal SEPSIS
Status
Completed
Phase
Early Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Lactoferrin
Placebos
Sponsored by
About this trial
This is an interventional prevention trial for Neonatal SEPSIS focused on measuring lactoferrin
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.
Sites / Locations
- Ayman
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
placebo
lacoferrin
Arm Description
saline is given orally in dose of 2 ml per day for one month
Pravotin is given orally 100 mg per sachet dissolved in 5 ml water given for one month
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
Full Information
NCT ID
NCT04094597
First Posted
April 4, 2019
Last Updated
September 13, 2019
Sponsor
Cairo University
Collaborators
Kasr El Aini Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04094597
Brief Title
Safety and Efficacy of Oral Bovine Lactoferrin
Acronym
Lactoferrin
Official Title
Effectivness and Safety of Oral Bovine Lactoferrin in Neonatal Sepsis and Necrotizing Enterocolitis and Its Effect on Anaemia of Prematurity
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
December 28, 2018 (Actual)
Study Completion Date
March 2, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
Collaborators
Kasr El Aini Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal SEPSIS
Keywords
lactoferrin
7. Study Design
Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
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
Masking
Investigator
Masking Description
Follow up of the patients with CRP and different cultures.
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
saline is given orally in dose of 2 ml per day for one month
Arm Title
lacoferrin
Arm Type
Active Comparator
Arm Description
Pravotin is given orally 100 mg per sachet dissolved in 5 ml water given for one month
Intervention Type
Drug
Intervention Name(s)
Lactoferrin
Other Intervention Name(s)
Pravotin sachets
Intervention Description
lactoferrin is given orally in comparsion to placebp
Intervention Type
Drug
Intervention Name(s)
Placebos
Other Intervention Name(s)
saline
Intervention Description
placebp is given in 2 ml saline
Primary Outcome Measure Information:
Title
Change in mortality rate of neonatal sepsis in preterm neonate
Description
Neonates will be assessed by C-reactive protein and different cultures to identify Neonatal sepsis
Time Frame
one year
Title
Number of Preterm Neonates who will have long term Complication after one month of regular use of Lactoferrin
Description
Neonates will be assessed for long term complication as necrotizing enterocolitis , retinoapathy of prematurity and bronchopulmonary dysplasia
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
7 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ayman zaher, bachelor
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ayman
City
Assiut
State/Province
Assuit
ZIP/Postal Code
71111
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
lactoferrin improves the mortality rate of neonatal sepsis
IPD Sharing Time Frame
all the time
IPD Sharing Access Criteria
lactoferrin
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/?term=lacoferrin
Description
lactoferrin
Learn more about this trial
Safety and Efficacy of Oral Bovine Lactoferrin
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