Early Versus Late Lactoferrin in Prevention of Neonatal Sepsis

Sponsor

Ain Shams University (Other)

Overall Status

Completed

CT.gov ID

NCT02959229

Collaborator

(none)

180

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neonatal Sepsis	Drug: Lactoferrin Drug: Placebo (for Lactoferrin)	Phase 4

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

Actual Enrollment :

180 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Care Provider)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Aug 1, 2014

Actual Primary Completion Date :

Dec 1, 2015

Actual Study Completion Date :

Oct 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Early Lactoferrin Group Oral Bovine Lactoferrin 100 mg/day once starting on day 1 of life and continued for 4-6 weeks.	Drug: Lactoferrin Other Names: Bovine Lactoferrin
Experimental: Late Lactoferrin Group Oral Bovine Lactoferrin 100 mg/day once starting on day 3 of life and continued for 4-6 weeks.	Drug: Lactoferrin Other Names: Bovine Lactoferrin
Active Comparator: Placebo Group placebo in form of distilled water once starting on day 1 of life and continued for 4-6 weeks.	Drug: Placebo (for Lactoferrin) placebo in form of distilled water

Arm

Intervention/Treatment

Experimental: Early Lactoferrin Group

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

Drug: Lactoferrin

Other Names:

Bovine Lactoferrin

Experimental: Late Lactoferrin Group

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

Drug: Lactoferrin

Other Names:

Bovine Lactoferrin

Active Comparator: Placebo Group

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

Drug: Placebo (for Lactoferrin)

placebo in form of distilled water

Outcome Measures

Primary Outcome Measures

Evaluate the effectiveness of oral Lactoferrin in prevention of neonatal sepsis according to Tollner score, hematological scoring system (HSS) and positive blood culture. [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 [4-6 weeks of life]

Secondary Outcome Measures

Effect of Lactoferrin supplementation on long term complications [4-6 weeks of life]
Long term complications as: Broncho-Pulmonary Dysplasia using clinical symptoms and signs and chest X ray findings. Retinopathy of Prematurity using the International Classification of Retinopathy of Prematurity (ICROP). Necrotizing Enterocolitis using Modified Bell's criteria for staging Necrotizing Enterocolitis.
any reported side effects for Bovine Lactoferrin [4-6 weeks of life]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 3 Days

Sexes Eligible for Study:

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.