Safety and Efficacy of Oral Bovine Lactoferrin

NCT04094597 | Completed Early Phase 1 DMC

• 2 other identifiers: Abu Elrich children hospital01525316
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Oral lactoferrin versus Placebo will be given to preterm neonates

Conditions

Neonatal SEPSIS

Keywords

lactoferrin

Outcome Measures

Primary Outcomes (2)

• 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

  one year

• 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

  one year

Study Arms (2)

placebo

PLACEBO COMPARATOR

saline is given orally in dose of 2 ml per day for one month

Drug: Placebos

lacoferrin

ACTIVE COMPARATOR

Pravotin is given orally 100 mg per sachet dissolved in 5 ml water given for one month

Drug: Lactoferrin

Interventions

Lactoferrin DRUG

lactoferrin is given orally in comparsion to placebp

Also known as: Pravotin sachets

lacoferrin

Placebos DRUG

placebp is given in 2 ml saline

Also known as: saline

placebo

Eligibility Criteria

• Age: 1 Day - 7 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• All neonates born at Cairo university hospital NICU

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead
• Kasr El Aini Hospital: collaborator

Study Sites (1)

Ayman

Asyut, Assuit, 71111, Egypt

Location

Related Links

• lactoferrin

MeSH Terms

Conditions

Neonatal Sepsis

Interventions

Lactoferrin; Sodium Chloride

Condition Hierarchy (Ancestors)

Sepsis; Infections; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Glycoproteins; Glycoconjugates; Carbohydrates; Transferrins; Iron-Binding Proteins; Carrier Proteins; Proteins; Amino Acids, Peptides, and Proteins; Lactoglobulins; Whey Proteins; Milk Proteins; Animal Proteins, Dietary; Dietary Proteins; Globulins; Metalloproteins; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• ayman zaher, bachelor

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Follow up of the patients with CRP and different cultures.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Pediatrics

Model Details: 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

Study Record Dates

• First Submitted: April 4, 2019
• First Posted: September 19, 2019
• Study Start: January 1, 2018
• Primary Completion: December 28, 2018
• Study Completion: March 2, 2019
• Last Updated: September 19, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR, ANALYTIC CODE
• Time Frame: all the time
• Access Criteria: lactoferrin

Locations

EG (1)