NCT02959229

Early Versus Late Lactoferrin in Prevention of Neonatal Sepsis

Systematic Randomized , Single Blinded, Placebo-Controlled Trial of Early Versus Late Lactoferrin in Prevention of Neonatal Sepsis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: 3 Days
• Healthy volunteers: Accepted

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.

Conditions

• Neonatal Sepsis

Interventions

Type	Name	Description
DRUG	Lactoferrin
DRUG	Placebo (for Lactoferrin)	placebo in form of distilled water

Timeline

• Start date: 2014-08-01
• Primary completion: 2015-12-01
• Completion: 2016-10-01
• First posted: 2016-11-09
• Last updated: 2016-11-09