Safety and Tolerability of Lactoferrin/FOS in Very Low Birth Weight Infants

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Primary Outcome Measures:

  • Definitely related study solution serious adverse event [ Time Frame: 30 days while receiving study solution ]
Secondary Outcome Measures:

  • Day after birth to reach 120ml/kg of enteral feeds [ Time Frame: 30 days while receiving study solution ]
  • Number of days not receiving any feedings after lactoferrin/FOS administration [ Time Frame: 30 days while receiving study solution ]

Aim 1: To evaluate the safety and tolerability of three different lactoferrin/FOS doses in preterm infants

  1. Lactoferrin/FOS related adverse events and serious adverse events
  2. Time reaching full feeds while receiving lactoferrin/FOS (120 ml/kg/day)
  3. Episodes of not receiving enteral feedings for > 24 hours once feeding is initiated

Aim 2: To evaluate lactoferrin/FOS absorption and excretion

  1. Examine lactoferrin/FOS levels in saliva, urine, plasma, and stool
  2. Examine lactoferrin levels in materal and human donor milk

Aim 3: To evaluate the effect of lactoferrin/FOS on the intestinal microbiome structure