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Early Versus Late Lactoferrin in Prevention of Neonatal Sepsis

Primary Purpose

Neonatal Sepsis

Status

Completed

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Lactoferrin

Placebo (for Lactoferrin)

About this trial

This is an interventional prevention trial for Neonatal Sepsis focused on measuring Late onset sepsis, Bovine Lactoferrin

Eligibility Criteria

undefined - 3 Days (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Early Lactoferrin Group

Late Lactoferrin Group

Placebo Group

Arm Description

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

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

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

Outcomes

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.

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

Secondary Outcome Measures

Effect of Lactoferrin supplementation on long term complications

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

Full Information

NCT ID

NCT02959229

First Posted

October 27, 2016

Last Updated

November 5, 2016

Sponsor

Ain Shams University

1. Study Identification

Unique Protocol Identification Number

NCT02959229

Brief Title

Early Versus Late Lactoferrin in Prevention of Neonatal Sepsis

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Completed

Study Start Date

August 2014 (undefined)

Primary Completion Date

December 2015 (Actual)

Study Completion Date

October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ain Shams University

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neonatal Sepsis

Keywords

Late onset sepsis, Bovine Lactoferrin

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Care Provider

Allocation

Randomized

Enrollment

180 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Early Lactoferrin Group

Arm Type

Experimental

Arm Description

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

Arm Title

Late Lactoferrin Group

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo Group

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Lactoferrin

Other Intervention Name(s)

Bovine Lactoferrin

Intervention Type

Drug

Intervention Name(s)

Placebo (for Lactoferrin)

Intervention Description

placebo in form of distilled water

Primary Outcome Measure Information:

Title

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

Title

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 Outcome Measure Information:

Title

Effect of Lactoferrin supplementation on long term complications

Description

Time Frame

4-6 weeks of life

Title

any reported side effects for Bovine Lactoferrin

Time Frame

4-6 weeks of life

10. Eligibility

Sex

All

Maximum Age & Unit of Time

3 Days

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ghada I Ghad, Professor

Organizational Affiliation

Ain Shams University

Official's Role

Study Director

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

26224129

Citation

Kaur G, Gathwala G. Efficacy of Bovine Lactoferrin Supplementation in Preventing Late-onset Sepsis in low Birth Weight Neonates: A Randomized Placebo-Controlled Clinical Trial. J Trop Pediatr. 2015 Oct;61(5):370-6. doi: 10.1093/tropej/fmv044. Epub 2015 Jul 29.

Results Reference

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PubMed Identifier

24709463

Citation

Manzoni P, Meyer M, Stolfi I, Rinaldi M, Cattani S, Pugni L, Romeo MG, Messner H, Decembrino L, Laforgia N, Vagnarelli F, Memo L, Bordignon L, Maule M, Gallo E, Mostert M, Quercia M, Bollani L, Pedicino R, Renzullo L, Betta P, Ferrari F, Alexander T, Magaldi R, Farina D, Mosca F, Stronati M. Bovine lactoferrin supplementation for prevention of necrotizing enterocolitis in very-low-birth-weight neonates: a randomized clinical trial. Early Hum Dev. 2014 Mar;90 Suppl 1:S60-5. doi: 10.1016/S0378-3782(14)70020-9.

Results Reference

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Early Versus Late Lactoferrin in Prevention of Neonatal Sepsis

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