Lactoferrin for Prevention of Sepsis in Infants

Principal Investigator:

Theresa Ochoa, M.D., University of Texas Health Science Center at Houston (UTHealth)

Co-Investigators:

Thomas Cleary, M.D., Memorial Hermann Memorial City Medical Center

Linda Ewing-Cobbs, Ph.D., University of Texas Health Science Center at Houston (UTHealth)

Funding Agency:

National Institute of Child Health and Human Development/National Institutes of Health

Description of Project:

The high frequency of serious infections in premature infants, as well as their associated morbidity and mortality, is the critical barrier to progress in improving infant care. We hypothesize that lactoferrin is the major factor in milk responsible for these protective effects (decreased rates of infection and improved neurodevelopment) due to its antimicrobial, anti-inflammatory, and immunomodulatory properties.  In a longitudinal randomized double blind placebo-controlled clinical trial of neonates with a birth weight between 500g and 2000g, we will address the following questions:

  1. What is the impact of lactoferrin on subsequent neurodevelopment and growth?  
  2. What is the impact of lactoferrin in higher risk populations? 
  3. What is the impact of lactoferrin in larger infants? 
  4. What is the optimal dose and duration of lactoferrin supplementation?

This study, if successful, will fundamentally change current clinical care of neonates, both in the developed and developing world, and could improve the quality of life of the infants and their families.

Sites:

Lima, Peru

Timeline:

2011-2016