- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04094597
Safety and Efficacy of Oral Bovine Lactoferrin (Lactoferrin)
September 13, 2019 updated by: ayman zaher, Cairo University
Effectivness and Safety of Oral Bovine Lactoferrin in Neonatal Sepsis and Necrotizing Enterocolitis and Its Effect on Anaemia of Prematurity
Oral lactoferrin versus Placebo will be given to preterm neonates
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
200
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Assuit
-
Assiut, Assuit, Egypt, 71111
- Ayman
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 day to 1 week (CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: placebo
saline is given orally in dose of 2 ml per day for one month
|
placebp is given in 2 ml saline
Other Names:
|
ACTIVE_COMPARATOR: lacoferrin
Pravotin is given orally 100 mg per sachet dissolved in 5 ml water given for one month
|
lactoferrin is given orally in comparsion to placebp
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
one year
|
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
|
one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: ayman zaher, bachelor, Cairo University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 1, 2018
Primary Completion (ACTUAL)
December 28, 2018
Study Completion (ACTUAL)
March 2, 2019
Study Registration Dates
First Submitted
April 4, 2019
First Submitted That Met QC Criteria
September 13, 2019
First Posted (ACTUAL)
September 19, 2019
Study Record Updates
Last Update Posted (ACTUAL)
September 19, 2019
Last Update Submitted That Met QC Criteria
September 13, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Abu Elrich children hospital
- 01525316 (REGISTRY: Lactoferrin for prevention of neonatal sepsis)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
lactoferrin improves the mortality rate of neonatal sepsis
IPD Sharing Time Frame
all the time
IPD Sharing Access Criteria
lactoferrin
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Neonatal SEPSIS
-
Jip GroenInBiomeRecruitingMicrobial Colonization | Neonatal Infection | Neonatal Sepsis, Early-Onset | Microbial Disease | Clinical Sepsis | Culture Negative Neonatal Sepsis | Neonatal Sepsis, Late-Onset | Culture Positive Neonatal SepsisNetherlands
-
Yale UniversityWithdrawnA Pilot Randomized Controlled Trial for Antibiotic Exposure in Neonatal Sepsis Using Neutrophil CD64Neonatal Early-onset Sepsis | Neonatal Late-onset SepsisUnited States
-
Franciscus GasthuisErasmus Medical CenterCompletedNeonatal Infection | Neonatal SEPSISNetherlands
-
prof. dr. Frans B. PlötzDutch Society of Pediatrics; Zorgevaluatie Nederland; Care4Neo; everywhereIMRecruitingEOS | Early-Onset Sepsis, NeonatalNetherlands
-
Drugs for Neglected DiseasesUniversiteit Antwerpen; PENTA Foundation; St George's, University of LondonCompletedNeonatal SEPSISBangladesh, Uganda, Thailand, South Africa, Italy, Greece, India, Brazil, China, Kenya, Vietnam
-
Assiut UniversityUnknown
-
Assiut UniversityUnknown
-
Sohag UniversityNot yet recruiting
-
Assiut UniversityUnknown
-
Shandong UniversityShandong Provincial HospitalRecruitingEarly-Onset Neonatal SepsisChina
Clinical Trials on Placebos
-
Yiling Pharmaceutical Inc.Completed
-
Nova Scotia Health AuthorityRecruiting
-
Beth Israel Deaconess Medical CenterTerminated
-
Intra-Cellular Therapies, Inc.CompletedBipolar Depression | Major Depressive DisorderUnited States, Bulgaria, Russian Federation, Serbia, Ukraine
-
Josef Smolen, Univ. Prof. Dr.Unknown
-
GE HealthcareSyneos HealthTerminatedChronic Kidney DiseasesUnited States, Spain, Belgium, Canada, Poland, United Kingdom
-
Viela BioCTI Clinical Trial and Consulting ServicesTerminated
-
Nanjing Sanhome Pharmaceutical, Co., Ltd.Completed
-
Biohaven Pharmaceuticals, Inc.Active, not recruitingSpinocerebellar Ataxia Type 3 | Spinocerebellar Ataxias | Spinocerebellar Ataxia Type 1 | Spinocerebellar Ataxia Type 2 | Spinocerebellar Ataxia Type 6 | Spinocerebellar Ataxia Type 10 | Spinocerebellar Ataxia Type 7 | Spinocerebellar Ataxia Type 8United States, China
-
University Hospital, BrestEli Lilly and CompanyCompletedPolymyalgia Rheumatic (PMR)France