Human Milk Cream as a Caloric Supplement in Pre-Term Infants

Once fortification (to either mother's or donor milk) is initiated and tolerance is established (based on clinical observation), infants will be randomized into one of two groups: to receive human milk cream or not.

* Human Milk Cream Group: Human milk (either mother's own or donor) will be tested (once per container of milk). If the caloric level falls below 20 kcal/oz, then an appropriate amount of human milk cream will be added to the milk to bring the content as close as possible to 20 kcal/oz. * Control Group (no human milk cream): Milk (either mother's own or donor) and human milk fortifier will be provided as usual (milk will be analyzed for study purposes).

This nutritional algorithm will continue until the infant reaches 36 weeks corrected gestational age/weaned from fortifier (whichever comes first) or is otherwise removed from the study (due to transfer to non-study institution, removal from the study or death).

Data will be collected from the time of study entry until the infant reaches 36 weeks corrected gestational age or weaned from the fortifier (whichever comes first) or is otherwise removed from the study.

Primary measure of efficacy:

The primary measure of efficacy for the study is the rate of change of weight from the initiation of enteral feeding through 36 weeks corrected gestational age or weaned from fortifier, whichever comes first. Based on an intent-to-treat (ITT) paradigm, if a study subject fails to complete the study period for any reason, this rate will be determined for the period of time on study. In order to provide a valid comparison between the study subjects, the rate of weight gain will be reported as g/kg/day. In a per-protocol analysis, these subjects will be dropped from any calculations with respect to this primary endpoint.

Primary measure of safety:

For the evaluation of safety, any untoward effects deemed to be related to the nutritional regimen will be identified and recorded. Key outcomes in this regard include feeding intolerance, necrotizing enterocolitis (NEC) and sepsis. Because this population has a high associated morbidity, episodes of apnea, and the use of oxygen and ventilators will be evaluated from a safety perspective.

Baseline measures: (study entry, i.e. initiation of enteral feeding)

At study entry, the following variables will be recorded: birth weight, gestational age, gender, Apgar score at 5 minutes, use of mechanical ventilation at study entry, use of prenatal or postnatal steroids, and the age in days at which enteral feeding was initiated. In addition the presence of any of the following clinical conditions either at the time of study entry or occurring during the course of the study will be noted: transient tachypnea of newborn (TTN), intraventricular hemorrhage (IVH) and grade, and patent ductus arteriosis (PDA).