Oral Lactoferrin Supplementation for Prevention of Sepsis in Preterm Neonate

Mooselmokadem

Status and phase: Unknown; Early Phase 1

Conditions: Neonatal Sepsis

Treatments: Dietary Supplement: Lactoferrin; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01821989

moos80

Details and patient eligibility

About

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.

Enrollment: 180 estimated patients

Sex: All

Ages: Under 28 days old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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180 participants in 3 patient groups, including a placebo group

Low Dose

Active Comparator group

Description:

Lactoferrin,dose of 100 mg/day.

Treatment:

Dietary Supplement: Lactoferrin

Dietary Supplement: Lactoferrin

High Dose

Experimental group

Description:

Lactoferrin, dose of 150 mg/kg/ twice daily.

Treatment:

Dietary Supplement: Lactoferrin

Dietary Supplement: Lactoferrin

Control

Placebo Comparator group

Description:

Receive placebo in form of distilled water.

Treatment:

Dietary Supplement: Placebo