Preterm infants are susceptible to postnatal growth restriction. Breast milk is the recommended source of nutrition for preterm infants. As preterm infants have enhanced nutritional requirements, multicomponent fortifiers are added to breast milk in order to establish adequate growth. Due to the various benefits of human milk feds to preterm infants, a human milk fortifier based on donor milk (Prolact+6 H2MF® Prolacta, City of Industry, California) has been developed. With this study, the investigators want to evaluate the effect of human milk fortification on weight gain in extremely low birth weight infants (ELBW, \<1000g birth weight) in comparison to bovine fortification.
Preterm infants are susceptible to postnatal growth restriction. Breast milk is the recommended source of nutrition for preterm infants. Many positive short-term health effects like prevention necrotizing enterocolitis , effects on gut development and immunological issues are associated with breast milk feedings. The composition of breast milk usually meets the nutritional demands of term infants. As preterm infants have enhanced nutritional requirements, multicomponent fortifiers are added to breast milk in order to establish adequate growth and proper neurodevelopmental outcome. Due to the various benefits of human milk feds to preterm infants, a human milk fortifier based on donor milk (Prolact+6 H2MF® Prolacta, City of Industry, California) has been developed. This human milk fortifier contains more energy and protein than bovine milk fortifiers. So far, accurate data on growth and weight gain under an exclusive diet with human milk and the human milk fortifier Prolact+6H2MF®are missing. With this study, the investigators want to evaluate the impact of a human milk based fortifier on weight gain in extremely low birth weight infants (ELBW, \<1000g birth weight) in comparison to bovine milk based fortifier.
Study Type
OBSERVATIONAL
Enrollment
196
Intervention is started with an enteral intake of 100 ml/kg until 32 weeks corrected for prematurity, afterwards a human milk fortifier based on bovine milk is administered until estimated date of birth or 52 weeks corrected for prematurity (weight \<10. percentile) according to ESPGHAN(=European Society for paediatric gastroenterology, hepatology and nutrition) guidelines
Paracelsus Medical University
Salzburg, Austria
Medical University of Vienna
Vienna, Austria
growth velocity g/kg/d at 37+0 weeks
weight gain in g/kg/d
Time frame: at 37+0 weeks of gestation
growth velocity g/kg/d at 32+0 weeks
weight gain in g/kg/d
Time frame: at 32+0 weeks of gestation
growth velocity g/kg/d from start of fortification to 32+0 weeks
weight gain in g/kg/d
Time frame: at 32+0 weeks of gestation
Weight at 32+0
weight in grams
Time frame: at 32 weeks of gestation
Weight at 37+0
weight in grams
Time frame: at 37+0 weeks of gestation
Length at 32+0
Length in cm
Time frame: at 32+0 weeks of gestation
Length gain at 32+0
Length gain in cm/week
Time frame: at 32+0 weeks of gestation
Head circumference at 32+0
head circumference in cm
Time frame: at 32+0 weeks of gestation
Head circumference gain at 32+0
head circumference gain in cm/week
Time frame: at 32+0 weeks of gestation
Length at 37+0
Length in cm
Time frame: at 37 weeks of gestation
Lengthgain at 37+0
Lengthgain in cm/week
Time frame: at 37 weeks of gestation
Head circumference at 37+0
Head circumference in cm
Time frame: at 37 weeks of gestation
Head circumference gain at 37+0
Head circumference gain in cm/week
Time frame: at 37 weeks of gestation
Time to full enteral feeds
Day of life when full enteral feeds (140ml/kg) are tolerated
Time frame: up to 37 weeks of gestation
Incidence of necrotising enterocolitis
Necrotizing enterocolitis stage 2a according to Bell
Time frame: up to 37 weeks of gestation
Body composition
Fat and Fat- free mass measured by Body plethysmography
Time frame: up to 6 months corrected for prematurity
Blood parameter total protein
laboratory parameter
Time frame: up to 37 weeks of gestation
Blood parameter Urea
laboratory parameter
Time frame: up to 37 weeks of gestation
Blood parameter Triglyceride
laboratory parameter
Time frame: up to 37 weeks of gestation
Blood parameter Glucose
laboratory parameter
Time frame: up to 37 weeks of gestation
z- scores
z-scores for weight , length and head circumference
Time frame: at 37 weeks of gestation
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.