Safety and Efficacy of Oral Bovine Lactoferrin

Sponsor

Cairo University (Other)

Overall Status

Completed

CT.gov ID

NCT04094597

Collaborator

Kasr El Aini Hospital (Other)

200

Enrollment

Location

Arms

Actual Duration (Months)

14.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Oral lactoferrin versus Placebo will be given to preterm neonates

Condition or Disease	Intervention/Treatment	Phase
Neonatal SEPSIS	Drug: Lactoferrin Drug: Placebos	Early Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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 patientplacebo 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:

Single (Investigator)

Masking Description:

Follow up of the patients with CRP and different cultures.

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jan 1, 2018

Actual Primary Completion Date :

Dec 28, 2018

Actual Study Completion Date :

Mar 2, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change in mortality rate of neonatal sepsis in preterm neonate [one year]
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 [one year]
Neonates will be assessed for long term complication as necrotizing enterocolitis , retinoapathy of prematurity and bronchopulmonary dysplasia

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Day to 7 Days

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ayman	Assiut	Assuit	Egypt	71111

Sponsors and Collaborators

Cairo University
Kasr El Aini Hospital

Investigators

Principal Investigator: ayman zaher, bachelor, Cairo University

Study Documents (Full-Text)

Statistical Analysis Plan - Jun 1, 2019

More Information

Additional Information:

lactoferrin

Publications

None provided.

Responsible Party:

ayman zaher, Resident of Pediatrics, Cairo University

ClinicalTrials.gov Identifier:

NCT04094597

Other Study ID Numbers:

Abu Elrich children hospital
01525316

First Posted:

Sep 19, 2019

Last Update Posted:

Sep 19, 2019

Last Verified:

Sep 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by ayman zaher, Resident of Pediatrics, Cairo University

lactoferrin

Additional relevant MeSH terms:

Sepsis

Neonatal Sepsis

Lactoferrin

Study Results

No Results Posted as of Sep 19, 2019