Trial | NCT01821989  Report issue

Title

Oral Lactoferrin Supplementation for Prevention of Sepsis in Preterm Neonate
Oral Lactoferrin Supplementation for Prevention of Sepsis in Preterm Neonate.

  • Phase

    Early Phase 1

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    lactoferrin ...

  • Study Participants

    180
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 Started
Jun 30
2013
Primary Completion
Jan 31
2016
Anticipated
Last Update
May 12
2014
Estimate

Dietary Supplement Lactoferrin

dose of 100 mg/day

Dietary Supplement Lactoferrin

dose of 150 mg/kg/ twice daily

Dietary Supplement Placebo

in form of distilled water

Low Dose Active Comparator

Lactoferrin,dose of 100 mg/day.

High Dose Experimental

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

Control Placebo Comparator

Receive placebo in form of distilled water.

Criteria 

Inclusion Criteria:

Neonates with a birth weight between 500g and 2500g.
Neonates with a ≤ 36 weeks of gestation counting from the first day of the Last Menstrual Period.
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:

Neonates with underlying gastrointestinal problems that prevent oral intake.
Neonates with predisposing conditions that profoundly affect growth and development (chromosomal abnormalities, structural brain anomalies, severe congenital abnormalities).
Neonates with a family background of cow milk allergy.
Neonates who will not have the chance to complete the study time (who will be referred to another hospitals).
Neonates whose parents decline to participate.
Neonates with early onset sepsis.
No Results Posted