Oral Lactoferrin Supplementation for Prevention of Sepsis in Preterm Neonate
1 other identifier
interventional
180
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 27, 2013
CompletedFirst Posted
Study publicly available on registry
April 1, 2013
CompletedStudy Start
First participant enrolled
June 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedMay 12, 2014
May 1, 2014
2.6 years
March 27, 2013
May 8, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Blood culture
2 years
Secondary Outcomes (1)
Complete blood count with differential leucocytic count.
2 years
Other Outcomes (1)
C reactive protein quantitative assay
2 years
Study Arms (3)
Low Dose
ACTIVE COMPARATORLactoferrin,dose of 100 mg/day.
High Dose
EXPERIMENTALLactoferrin, dose of 150 mg/kg/ twice daily.
Control
PLACEBO COMPARATORReceive placebo in form of distilled water.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mooselmokademlead
Study Sites (1)
Ain Shams University
Cairo, Abassia, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- neonatologist
Study Record Dates
First Submitted
March 27, 2013
First Posted
April 1, 2013
Study Start
June 1, 2013
Primary Completion
January 1, 2016
Last Updated
May 12, 2014
Record last verified: 2014-05