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

Sponsors

Lead Sponsor: Ain Shams University

Source Ain Shams University
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.

Overall Status Completed
Start Date August 2014
Completion Date October 2016
Primary Completion Date December 2015
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
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
Measure Time Frame
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
Enrollment 180
Condition
Intervention

Intervention Type: Drug

Intervention Name: Lactoferrin

Other Name: Bovine Lactoferrin

Intervention Type: Drug

Intervention Name: Placebo (for Lactoferrin)

Description: placebo in form of distilled water

Arm Group Label: Placebo Group

Eligibility

Criteria:

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.

Gender: All

Minimum Age: N/A

Maximum Age: 3 Days

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Ghada I Ghad, Professor Study Director Ain Shams University
Verification Date

November 2016

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Ain Shams University

Investigator Full Name: Atef Nagy Mohamed

Investigator Title: clinical researcher

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: Early Lactoferrin Group

Type: Experimental

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

Label: Late Lactoferrin Group

Type: Experimental

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

Label: Placebo Group

Type: Active Comparator

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

Patient Data Undecided
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Prevention

Masking: Single (Care Provider)

Source: ClinicalTrials.gov