Oral Lactoferrin Supplementation for Prevention of Sepsis in Preterm Neonate

Early Phase 1

• Conditions: Neonatal Sepsis
• Interventions: Dietary Supplement: Lactoferrin; Dietary Supplement: Placebo

• Registration Number: NCT01821989
• Lead Sponsor: Mooselmokadem

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-03-27
• Study First Submitted QC: 2013-03-29
• Study First Posted: 2013-04-01
• Study Start: 2013-06
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-08
• Last Update Posted: 2014-05-12
• Primary Completion: 2016-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low Dose	Lactoferrin	Lactoferrin,dose of 100 mg/day.
High Dose	Lactoferrin	Lactoferrin, dose of 150 mg/kg/ twice daily.
Control	Placebo	Receive placebo in form of distilled water.

Primary Outcome Measures

Name	Time	Method
Blood culture	2 years

Secondary Outcome Measures

Name	Time	Method
Complete blood count with differential leucocytic count.	2 years

Trial Locations

Locations (1)

Ain Shams University; 🇪🇬 Cairo, Abassia, Egypt