Evaluation of Prolact-Plus Human Milk Fortifier

This will be a cohort designed study in pre-term infants (<32 weeks of gestation) comparing bovine fortified (using any one of the commercially available fortifier products) human milk with Prolact-Plus (human) fortified human milk in which the former cohort will be obtained retrospectively and the latter obtained prospectively in each participating institution. The number of infants to be included in this study is a minimum of 50 in each group who complete the 30 days on study. (If a baby drops out of the study prior to 30 days of evaluation, then they would be replaced in order to achieve that number.) This sample size was not determined statistically, but rather is based solely on the desire to obtain a reasonable amount of data to evaluate the new human fortifier in this setting. However, from the perspective of a non-inferiority evaluation of an endpoint such as feeding intolerance, consider the following. Assuming a rate of 15% for this outcome for the retrospective cohort, then with 50 subjects per cohort, the study would be able to demonstrate a lack of inferiority of the human-based fortifier with a delta of 20% using a power of slightly greater than 80% and a one-sided 2.5% significance level. (By a "delta of 20%" it is implied that a theoretical feeding intolerance rate for the Prolact-Plus of no worse than 35% would result in a conclusion of lack of inferiority with the given levels of significance and power.) Conversely, if the human-based fortifier is able to reduce the feeding intolerance rate from 15% to about 1%, then with the sample sizes in this trial, this would be doable with 80% power and 5% significance (two-sided). (Thus, the trial, in theory, also could demonstrate a dramatic reduction in this rate.) The retrospective data will be obtained from available medical charts at the participating institution and the selected infants should reflect the most recently treated (within the 12 month period prior to the initiation of the prospective phase of this protocol) and the numbers should be similar in kind to the number treated prospectively in that institution.

Inclusion criteria

• Between 23 and 32 weeks gestational age
• Weigh between 500 and 1600g
• In the retrospective group, an infant must have been able to adhere to a feeding protocol that included only mother's own milk fortified by either bovine or human product from the time that enteral feeding began (or whenever fortified human milk feeding began) through the next 30 days of life or hospital discharge, whichever came first.
• In the prospective group, the infant must be expected to be able to adhere to a feeding protocol that includes only mother's own milk fortified by the human product from the time that enteral feeding began (or whenever fortified human milk feeding began) through the next 30 days of life or hospital discharge, whichever comes first.
• Informed consent obtained from parent or legal guardian.
• Mother must be willing to adhere to a feeding protocol that includes 30 days of mother's own milk for the prospective arm of the study.

Exclusion criteria

• Less than a 50% probability of survival through the study period (first 30 days of enteral feeding or hospital discharge).
• On any other clinical study during the study period
• Receipt of any bovine-based formula or fortifier prior to the infant's enrollment in the study.