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

  • Egypt
    • 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
Drug: Placebos
placebp is given in 2 ml saline
Other Names:
  • saline
ACTIVE_COMPARATOR: lacoferrin
Pravotin is given orally 100 mg per sachet dissolved in 5 ml water given for one month
Drug: Lactoferrin
lactoferrin is given orally in comparsion to placebp
Other Names:
  • Pravotin sachets

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

Cairo University

Collaborators

Kasr El Aini Hospital

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.

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