Systematic Randomized , Single Blinded, Placebo-Controlled Trial of Early Versus Late Lactoferrin in Prevention of Neonatal Sepsis
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Ain Shams University
- Enrollment
- 180
- Primary Endpoint
- Evaluate the effectiveness of oral Lactoferrin in prevention of neonatal sepsis according to Tollner score, hematological scoring system (HSS) and positive blood culture.
Study Overview
Brief Summary
The present study was designed to evaluate the effectiveness of oral lactoferrin in prevention of neonatal sepsis with comparison early (1st day) versus late (48-72 hours) Lactoferrin administration, Secondary aim was to study effect of Lactoferrin administration on serum Ferritin and follow up long term outcome (Bronchopulmonary dysplasia, retinopathy of prematurity and necrotizing enterocolitis.
Detailed Description
This study was carried out on 180 preterm neonates(< 37 weeks of gestation counting from the first day of the Last Menstrual Period and confirmed by Ballard score) admitted to the Neonatal Intensive Care Units of Ain Shams University Hospitals in the period from August 2014 to December 2015.
Enrolled subjects were further randomly subdivided into three groups according to the dose regimen of Lactoferrin supplementation.
- Group A: (60 preterm neonates) who received oral Lactoferrin supplementation in a dose of 100 mg/day starting on day 1 and continue for 4-6 weeks.
- Group B: (60 preterm neonates) who received oral Lactoferrin supplementation in a dose of 100 mg/day starting on day 3 (48hrs-72hrs) of life and continue for 4-6 weeks.
- Group C: (60 preterm neonates) who match the subjected neonates, received placebo in form of distilled water.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Care Provider)
Eligibility Criteria
- Ages
- — to 3 Days (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Neonates with a < 37 weeks of gestation counting from the first day of the Last Menstrual Period.
- •Preterm neonates are breast fed, artificially fed or on total parenteral nutrition.
- •Preterm neonates born in, or referred to our Neonatal Intensive Care Unit in the first day of life free from infection and not fed.
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 with early onset sepsis.
- •Neonates whose parents decline to participate.
Arms & Interventions
Early Lactoferrin Group
Oral Bovine Lactoferrin 100 mg/day once starting on day 1 of life and continued for 4-6 weeks.
Intervention: Lactoferrin (Drug)
Late Lactoferrin Group
Oral Bovine Lactoferrin 100 mg/day once starting on day 3 of life and continued for 4-6 weeks.
Intervention: Lactoferrin (Drug)
Placebo Group
placebo in form of distilled water once starting on day 1 of life and continued for 4-6 weeks.
Intervention: Placebo (for Lactoferrin) (Drug)
Outcomes
Primary Outcomes
Evaluate the effectiveness of oral Lactoferrin in prevention of neonatal sepsis according to Tollner score, hematological scoring system (HSS) and positive blood culture.
Time Frame: 4-6 weeks of life
Compare early (1st day) versus late (48-72 hours) Lactoferrin administration on neonatal sepsis according to Tollner score, hematological scoring system (HSS) and positive blood culture
Time Frame: 4-6 weeks of life
Secondary Outcomes
- Effect of Lactoferrin supplementation on long term complications(4-6 weeks of life)
- any reported side effects for Bovine Lactoferrin(4-6 weeks of life)
Investigators
Atef Nagy Mohamed
clinical researcher
Ain Shams University