Human Milk Fortifier - Growth Evaluation

Launched by SOCIÉTÉ DES PRODUITS NESTLÉ (SPN) · Jan 16, 2013

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• 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.