Pilot Study: Lactoferrin for Prevention of Neonatal Sepsis

NCT01264536 | Completed Phase 2 DMC

• 2 other identifiers: SIDISI 56909OPP1015669
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 3

Brief Summary

We will test the hypothesis that bovine lactoferrin supplementation prevents serious infections in preterm infants. We will conduct a randomized placebo-controlled double blind study in 190 premature infants \<2500 gm in 5 Neonatal Intermediate and Intensive Care Units in Lima, Peru to determine whether bovine lactoferrin prevents the first episode of late-onset sepsis.

Conditions

Sepsis

Keywords

lactoferrin; sepsis; neonates; prevention; infections

Outcome Measures

Primary Outcomes (1)

• Number of confirmed episodes of late-onset sepsis.

  Number of confirmed episodes of late-onset sepsis in the first month of life

  1 month

Secondary Outcomes (1)

• Incidence of Gram positive and Gram negative bacterial and fungal bouts of sepsis, pneumonia, diarrhea and mortality

  1 month

Study Arms (2)

Lactoferrin

EXPERIMENTAL

Lactoferrin is a freeze-dried protein purified directly from fresh bovine milk.

Dietary Supplement: lactoferrin

maltodextrin

PLACEBO COMPARATOR

Maltodextrin is an inert sugar.

Dietary Supplement: Maltodextrin

Interventions

lactoferrin DIETARY_SUPPLEMENT

Infants will receive oral bovine lactoferrin (200 mg/Kg/day divided in three dosis) for 4 weeks. Lactoferrin will be dissolved in human milk or infant formula or in a 5% glucose solution. Each dose will be dissolved in a small volume so the maximum lactoferrin concentration will be 25mg/mL.

Also known as: Bovine lactoferrin

Lactoferrin

Maltodextrin DIETARY_SUPPLEMENT

Infants will receive oral maltodextrin (200mg/Kg/day in three divided dosis) for 4 weeks. Maltodextrin will be dissolved in human milk or infant formula or in a 5% glucose solution. Each dose will be dissolved in a small volume so the maximum maltodextrin concentration will be 25mg/mL.

maltodextrin

Eligibility Criteria

• Age: 24 Hours - 72 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Neonates with a birth weight between 500g and 2500g
• Neonates born in, or referred to the Neonatal Intermediate and Intensive Care Units of one of the participating hospitals in the first 72 hours of life.

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 that, according to the investigator criteria, will not have the chance to complete the subsequent study visits (patients that before one month old would not be living in Lima).
• Neonates whose parents decline to participate.

Sponsors & Collaborators

• Universidad Peruana Cayetano Heredia: lead

Study Sites (3)

Hospital Guillermo Almnara Irigoyen

Lima, Lima Province, Lima13, Peru

Location

Hospital Nacional Cayetano Heredia

Lima, Lima Province, Lima31, Peru

Location

Hospital Nacional Alberto Sabogal Sologuren

Callao, Lima, Callao2, Peru

Location

Related Publications (2)

• Manzoni P, Rinaldi M, Cattani S, Pugni L, Romeo MG, Messner H, Stolfi I, Decembrino L, Laforgia N, Vagnarelli F, Memo L, Bordignon L, Saia OS, Maule M, Gallo E, Mostert M, Magnani C, Quercia M, Bollani L, Pedicino R, Renzullo L, Betta P, Mosca F, Ferrari F, Magaldi R, Stronati M, Farina D; Italian Task Force for the Study and Prevention of Neonatal Fungal Infections, Italian Society of Neonatology. Bovine lactoferrin supplementation for prevention of late-onset sepsis in very low-birth-weight neonates: a randomized trial. JAMA. 2009 Oct 7;302(13):1421-8. doi: 10.1001/jama.2009.1403.

  PMID: 19809023 BACKGROUND

• Ochoa TJ, Zegarra J, Cam L, Llanos R, Pezo A, Cruz K, Zea-Vera A, Carcamo C, Campos M, Bellomo S; NEOLACTO Research Group. Randomized controlled trial of lactoferrin for prevention of sepsis in peruvian neonates less than 2500 g. Pediatr Infect Dis J. 2015 Jun;34(6):571-6. doi: 10.1097/INF.0000000000000593.

  PMID: 25973934 DERIVED

MeSH Terms

Conditions

Sepsis; Infections

Interventions

Lactoferrin; maltodextrin

Condition Hierarchy (Ancestors)

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

• Theresa J Ochoa, MD

  Universidad Peruana Cayetano Heredia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics, Universidad Peruana Cayetano Heredia

Study Record Dates

• First Submitted: December 20, 2010
• First Posted: December 21, 2010
• Study Start: December 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: December 1, 2011
• Last Updated: September 10, 2012

Record last verified: 2012-09

Locations

PE (3)