Pilot Study: Lactoferrin for Prevention of Neonatal Sepsis (NEOLACTO)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Theresa Ochoa, Universidad Peruana Cayetano Heredia
ClinicalTrials.gov Identifier:
NCT01264536
First received: December 20, 2010
Last updated: September 7, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Sepsis
Dietary Supplement: lactoferrin
Dietary Supplement: Maltodextrin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Pilot Study: Lactoferrin for Prevention of Neonatal Sepsis

Resource links provided by NLM:


Further study details as provided by Universidad Peruana Cayetano Heredia:

Primary Outcome Measures:
  • Number of confirmed episodes of late-onset sepsis. [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Number of confirmed episodes of late-onset sepsis in the first month of life


Secondary Outcome Measures:
  • Incidence of Gram positive and Gram negative bacterial and fungal bouts of sepsis, pneumonia, diarrhea and mortality [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Incidence of Gram positive and Gram negative bacterial and fungal bouts of sepsis, pneumonia, diarrhea and mortality in the first month of life.


Enrollment: 190
Study Start Date: December 2010
Study Completion Date: December 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lactoferrin
Lactoferrin is a freeze-dried protein purified directly from fresh bovine milk.
Dietary Supplement: lactoferrin
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.
Other Name: Bovine lactoferrin
Placebo Comparator: maltodextrin
Maltodextrin is an inert sugar.
Dietary Supplement: Maltodextrin
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.

Detailed Description:

Lactoferrin is an iron chelating protein with multiple physiological functions (anti-microbial, anti-inflammatory and immunomodulatory) and is one of the most important proteins present in mammalian milk. We hypothesize that lactoferrin as an oral supplement given daily to low birth weight will improve their health by mimicking their protective role in milk. There is extensive literature showing in vitro and in animal models the benefits of lactoferrin. However, there are few clinical trials designed to translate this knowledge into patient care.

We will conduct a pilot randomized, double-blinded placebo-controlled trial comparing daily supplementation with bovine lactoferrin versus placebo in neonates to reduce the incidence of sepsis in the first month of life. We will enroll 190 neonates with a birth weight less than 2,500 g, younger than 3 days of age in the neonatal intensive care unit of 5 pediatric hospitals in Lima, after informed consent of both parents. Infants will be followed in the hospital until death or discharge and then at home up to 1 month of age. Bovine lactoferrin will be used in this trial (200 mg/Kg per day). Although bovine and human lactoferrin are not identical, their bioactivity is quite comparable. Maltodextrin (an inert sugar) will be used for controls. The primary study outcome will be the number of first late-onset sepsis episodes (occurring >72h after birth with isolation of any pathogen in blood or cerebrospinal fluid).

  Eligibility

Ages Eligible for Study:   up to 72 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Neonates with a birth weight between 500g and 2500g
  2. 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.

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 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).
  5. Neonates whose parents decline to participate.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01264536

Locations
Peru
Hospital Nacional Alberto Sabogal Sologuren
Callao, Lima, Peru, Callao2
Hospital Nacional Cayetano Heredia
Lima, Peru, Lima31
Hospital Guillermo Almnara Irigoyen
Lima, Peru, Lima13
Sponsors and Collaborators
Universidad Peruana Cayetano Heredia
Investigators
Principal Investigator: Theresa J Ochoa, MD Universidad Peruana Cayetano Heredia
  More Information

Publications:
Responsible Party: Theresa Ochoa, Assistant Professor of Pediatrics, Universidad Peruana Cayetano Heredia, Universidad Peruana Cayetano Heredia
ClinicalTrials.gov Identifier: NCT01264536     History of Changes
Other Study ID Numbers: SIDISI 56909, OPP1015669
Study First Received: December 20, 2010
Last Updated: September 7, 2012
Health Authority: Peru: Instituto Nacional de Salud

Keywords provided by Universidad Peruana Cayetano Heredia:
lactoferrin
sepsis
neonates
prevention
infections

Additional relevant MeSH terms:
Sepsis
Toxemia
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Lactoferrin
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014