Human Milk Fortifier - Growth Evaluation

Evaluation of Growth of Pre-Term Infants Fed a Human Milk Fortifier

It it is hypothesized that the growth of preterm infants receiving a new human milk fortifier will be equal or superior to the growth of preterm infants receiving a currently marketed human milk fortifier with a lower protein content.

Inclusion Criteria:

• Birth weight ≤1500 g AND/OR gestational age ≤32 weeks (determined by maternal dates, fetal ultrasound, Dubowitz/Ballard examination or a combination thereof)
• Male or female
• Tolerating an enteral intake of human milk, donor milk or a combination at ≥100 mL/kg/d for ≥ 24 h
• Subject is anticipated to receive human milk, donor milk or a combination for ≥ 3 consecutive weeks after having achieved full fortification with volume intake contained between 150 and 180 mL/kg/d.
• Written informed consent has been obtained from the legal representative(s).

Exclusion Criteria:

• Infants with current systemic disease
• Infants with a history of systemic disease
• Any congenital anomalies of the GI tract that significantly interfere with nutrition and growth or previous GI surgery.
• Small size for gestational age (SGA) - body weight ≦ 5th percentile for that gestational age.
• Infants diagnosed with any inherent metabolic disease.
• Infants diagnosed with any chromosomic disease.
• Receiving any commercial formula supplementation to breast milk.
• Receiving steroids at the time of enrollment.
• Participation in another nutritional clinical trial that may affect outcomes of this study.