Early Versus Late Lactoferrin in Prevention of Neonatal Sepsis

Ain Shams University

Status and phase: Completed; Phase 4

Conditions: Neonatal Sepsis

Treatments: Drug: Lactoferrin; Drug: Placebo (for Lactoferrin)

Study type: Interventional

Funder types: Other

Identifiers

NCT02959229

FMASU M.S 23/2016

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 patients

Sex: All

Ages: Under 3 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Neonates with a < 37 weeks of gestation counting from the first day of the Last Menstrual Period.
2. Preterm neonates are breast fed, artificially fed or on total parenteral nutrition.
3. 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

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 with early onset sepsis.
6. Neonates whose parents decline to participate.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

180 participants in 3 patient groups

Early Lactoferrin Group

Experimental group

Description:

Oral Bovine Lactoferrin 100 mg/day once starting on day 1 of life and continued for 4-6 weeks.

Treatment:

Drug: Lactoferrin

Late Lactoferrin Group

Experimental group

Description:

Oral Bovine Lactoferrin 100 mg/day once starting on day 3 of life and continued for 4-6 weeks.

Treatment:

Drug: Lactoferrin

Placebo Group

Active Comparator group

Description:

placebo in form of distilled water once starting on day 1 of life and continued for 4-6 weeks.

Treatment:

Drug: Placebo (for Lactoferrin)