Early Versus Late Lactoferrin in Prevention of Neonatal Sepsis

NCT02959229 | Completed Phase 4 DMC

• 1 other identifier: FMASU M.S 23/2016
• Study Type: interventional
• Target: 180
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Neonatal Sepsis

Keywords

Late onset sepsis; Bovine Lactoferrin

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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

Study Arms (3)

Early Lactoferrin Group

EXPERIMENTAL

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

Drug: Lactoferrin

Late Lactoferrin Group

EXPERIMENTAL

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

Drug: Lactoferrin

Placebo Group

ACTIVE COMPARATOR

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

Drug: Placebo (for Lactoferrin)

Interventions

Lactoferrin DRUG

Also known as: Bovine Lactoferrin

Early Lactoferrin Group; Late Lactoferrin Group

Placebo (for Lactoferrin) DRUG

placebo in form of distilled water

Placebo Group

Eligibility Criteria

• Age: Up to 3 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Related Publications (2)

• 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.

  PMID: 26224129 BACKGROUND

• 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.

  PMID: 24709463 BACKGROUND

MeSH Terms

Conditions

Neonatal Sepsis

Interventions

Lactoferrin

Condition Hierarchy (Ancestors)

Sepsis; Infections; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Glycoproteins; Glycoconjugates; Carbohydrates; Transferrins; Iron-Binding Proteins; Carrier Proteins; Proteins; Amino Acids, Peptides, and Proteins; Lactoglobulins; Whey Proteins; Milk Proteins; Animal Proteins, Dietary; Dietary Proteins; Globulins; Metalloproteins

Study Officials

• Ghada I Ghad, Professor

  Ain Shams University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical researcher

Study Record Dates

• First Submitted: October 27, 2016
• First Posted: November 9, 2016
• Study Start: August 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: October 1, 2016
• Last Updated: November 9, 2016

Record last verified: 2016-11