Lactoferrin for Prevention of Sepsis in Infants

NCT01525316 | Completed Phase 3 DMC

• 2 other identifiers: SIDISI 577101R01HD067694-01A1
• Study Type: interventional
• Target: 414
• Locations: 1 country
• Sites: 3

Brief Summary

The investigators propose a clinical trial in premature infants to determine the effect of orally-administered bovine lactoferrin on occurrence of severe infections and to determine whether as a result of decreased infections, infants' growth and development improve after daily lactoferrin supplementation, due to its antimicrobial and anti-inflammatory properties. If successful, the use of lactoferrin as a protective protein could profoundly affect clinical care of neonates both in the developed and developing world.

Conditions

Late Onset Neonatal Sepsis

Keywords

Late Onset Neonatal Sepsis; Neonates; Lactoferrin; Infections; Prevention; Neurodevelopment

Outcome Measures

Primary Outcomes (1)

• First episode of late-onset sepsis or sepsis-associated death

  The primary study outcome will be a composite outcome of the first episode of late-onset sepsis or sepsis-associated death.

  72hrs to 8 weeks of age

Secondary Outcomes (1)

• Neurodevelopment

  12 to 24 months of corrected age

Study Arms (2)

Bovine Lactoferrin

EXPERIMENTAL

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

Dietary Supplement: Bovine Lactoferrin

Maltodextrin

PLACEBO COMPARATOR

Maltodextrin is an inert sugar.

Dietary Supplement: Maltodextrin

Interventions

Bovine Lactoferrin DIETARY_SUPPLEMENT

Infants will receive oral bovine lactoferrin (200 mg/Kg/day divided in three dosis) for 8 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: Lactoferrin

Bovine Lactoferrin

Maltodextrin DIETARY_SUPPLEMENT

Infants will receive oral maltodextrin (200mg/Kg/day in three divided dosis) for 8 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: 1 Hour - 72 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Neonates with a birth weight between 500g and 2000g
• 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 who have a family history 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
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (3)

Hospital Nacional Alberto Sabogal Sologuren

Lima, 0511, Peru

Location

Hospital Nacional Cayetano Heredia

Lima, 0511, Peru

Location

Hospital Nacional Guillermo Almenara Irigoyen

Lima, 0511, Peru

Location

Related Publications (8)

• 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 BACKGROUND

• Akin IM, Atasay B, Dogu F, Okulu E, Arsan S, Karatas HD, Ikinciogullari A, Turmen T. Oral lactoferrin to prevent nosocomial sepsis and necrotizing enterocolitis of premature neonates and effect on T-regulatory cells. Am J Perinatol. 2014 Dec;31(12):1111-20. doi: 10.1055/s-0034-1371704. Epub 2014 May 16.

  PMID: 24839144 BACKGROUND

• Torres Roldan VD, Urtecho S M, Gupta J, Yonemitsu C, Carcamo CP, Bode L, Ochoa TJ. Human milk oligosaccharides and their association with late-onset neonatal sepsis in Peruvian very-low-birth-weight infants. Am J Clin Nutr. 2020 Jul 1;112(1):106-112. doi: 10.1093/ajcn/nqaa102.

  PMID: 32401307 DERIVED

• Ochoa TJ, Zegarra J, Bellomo S, Carcamo CP, Cam L, Castaneda A, Villavicencio A, Gonzales J, Rueda MS, Turin CG, Zea-Vera A, Guillen D, Campos M, Ewing-Cobbs L; NEOLACTO Research Group. Randomized Controlled Trial of Bovine Lactoferrin for Prevention of Sepsis and Neurodevelopment Impairment in Infants Weighing Less Than 2000 Grams. J Pediatr. 2020 Apr;219:118-125.e5. doi: 10.1016/j.jpeds.2019.12.038. Epub 2020 Feb 6.

  PMID: 32037149 DERIVED

• Medina-Alva P, Duque KR, Zea-Vera A, Bellomo S, Carcamo C, Guillen-Pinto D, Rivas M, Tori A, Zegarra J, Cam L, Castaneda A, Villavicencio A, Ochoa TJ. Combined predictors of neurodevelopment in very low birth weight preterm infants. Early Hum Dev. 2019 Mar;130:109-115. doi: 10.1016/j.earlhumdev.2019.01.019. Epub 2019 Feb 8.

  PMID: 30743197 DERIVED

• Rueda MS, Calderon-Anyosa R, Gonzales J, Turin CG, Zea-Vera A, Zegarra J, Bellomo S, Cam L, Castaneda A, Ochoa TJ; NEOLACTO Research Group. Antibiotic Overuse in Premature Low Birth Weight Infants in a Developing Country. Pediatr Infect Dis J. 2019 Mar;38(3):302-307. doi: 10.1097/INF.0000000000002055.

  PMID: 29613975 DERIVED

• Turin CG, Zea-Vera A, Rueda MS, Mercado E, Carcamo CP, Zegarra J, Bellomo S, Cam L, Castaneda A, Ochoa TJ; NEOLACTO Research Group. Lactoferrin concentration in breast milk of mothers of low-birth-weight newborns. J Perinatol. 2017 May;37(5):507-512. doi: 10.1038/jp.2016.265. Epub 2017 Jan 26.

  PMID: 28125095 DERIVED

MeSH Terms

Conditions

Neonatal Sepsis; Infections

Interventions

Lactoferrin; maltodextrin

Condition Hierarchy (Ancestors)

Sepsis; 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

• Theresa J Ochoa, MD

  Universidad Peruana Cayetano Heredia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2012
• First Posted: February 2, 2012
• Study Start: May 1, 2012
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: December 6, 2021

Record last verified: 2021-12

Locations

PE (3)