Oral Lactoferrin Supplementation for Prevention of Sepsis in Preterm Neonate

Oral Lactoferrin Supplementation for Prevention of Sepsis in Preterm Neonate.

Hypothesis:

Orally ingested lactoferrin has effects on promotion of growth and differentiation of the immature gut; also it has immunomodulatory properties, so it will prevent serious infections in preterm infants.

The aim of the study is to:

• Evaluate the effectiveness of oral lactoferrin in prevention of neonatal sepsis.
• Compare two dose regiment of lactoferrin supplementation.
• Study effect of lactoferrin supplementation on serum iron stores.

It is a prospective, randomized, double blind, placebo-controlled study, it will include 180 preterm neonates admitted to the Neonatal Intensive Care Units of of Ain Shams University Hospitals and Manshiet El Bakry Hospital.

•Group A: Who will receive oral lactoferrin supplementation in a dose of 100 mg/day.

•Group B: Who will receive oral lactoferrin supplementation in a dose of 150 mg/kg/ twice daily.

•Group C (Controls): Who match the subjected neonates, will receive placebo in form of distilled water.

Study Overview

• Status: Unknown
• Conditions: Neonatal Sepsis
• Intervention / Treatment: Dietary supplement: Lactoferrin; Dietary supplement: Lactoferrin; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 180
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Mostafa AM Elmokadem, Master; Phone Number: 02 01110857100; Email: drmooselmokadem@hotmail.com

Study Locations

• Egypt
  • Abassia
    • Cairo, Abassia, Egypt
      • ain shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Neonates with a birth weight between 500g and 2500g.
2. Neonates with a ≤ 36 weeks of gestation counting from the first day of the Last Menstrual Period.
3. Preterm neonates born in, or referred to the Neonatal Intensive Care Units of one of the participating hospitals in the first 48 hours of life.

Exclusion Criteria:

1. Neonates with underlying gastrointestinal problems that prevent oral intake.
2. Neonates with predisposing conditions that profoundly affect growth and development (chromosomal abnormalities, structural brain anomalies, severe congenital abnormalities).
3. Neonates with a family background of cow milk allergy.
4. Neonates who will not have the chance to complete the study time (who will be referred to another hospitals).
5. Neonates whose parents decline to participate.
6. Neonates with early onset sepsis.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Low Dose; Lactoferrin,dose of 100 mg/day.	Dietary supplement: Lactoferrin; dose of 100 mg/day; Dietary supplement: Lactoferrin; dose of 150 mg/kg/ twice daily
Experimental: High Dose; Lactoferrin, dose of 150 mg/kg/ twice daily.	Dietary supplement: Lactoferrin; dose of 100 mg/day; Dietary supplement: Lactoferrin; dose of 150 mg/kg/ twice daily
Placebo Comparator: Control; Receive placebo in form of distilled water.	Dietary supplement: Placebo; in form of distilled water

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Blood culture	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Complete blood count with differential leucocytic count.	2 years

Other Outcome Measures

Outcome Measure	Time Frame
C reactive protein quantitative assay	2 years

Collaborators and Investigators

• Sponsor: Mooselmokadem

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Anticipated): January 1, 2016

Study Registration Dates

• First Submitted: March 27, 2013
• First Submitted That Met QC Criteria: March 29, 2013
• First Posted (Estimate): April 1, 2013

Study Record Updates

• Last Update Posted (Estimate): May 12, 2014
• Last Update Submitted That Met QC Criteria: May 8, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Infant, Newborn, Diseases; Sepsis; Toxemia; Neonatal Sepsis; Anti-Infective Agents; Lactoferrin
• Other Study ID Numbers: moos80