Early Versus Late Lactoferrin in Prevention of Neonatal Sepsis

NCT ID: NCT02959229

Last Updated: 2016-11-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2016-10-31

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.

Conditions

Neonatal Sepsis

Keywords

Late onset sepsis; Bovine Lactoferrin

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Early Lactoferrin Group

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

Group Type: EXPERIMENTAL

Lactoferrin

Intervention Type: DRUG

Late Lactoferrin Group

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

Group Type: EXPERIMENTAL

Lactoferrin

Intervention Type: DRUG

Placebo Group

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

Group Type: ACTIVE_COMPARATOR

Placebo (for Lactoferrin)

Intervention Type: DRUG

placebo in form of distilled water

Interventions

Lactoferrin

Intervention Type: DRUG

Placebo (for Lactoferrin)

placebo in form of distilled water

Intervention Type: DRUG

Other Intervention Names

Bovine Lactoferrin

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.

• Maximum Eligible Age: 3 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Atef Nagy Mohamed

clinical researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ghada I Ghad, Professor

Role: STUDY_DIRECTOR

Ain Shams University

References

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.

Reference Type: BACKGROUND

PMID: 26224129 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24709463 (View on PubMed)

Other Identifiers

FMASU M.S 23/2016

Identifier Type: -

Identifier Source: org_study_id