Extremely Low Birth Weight, Human Milk, Preterm Infants, Weight Gain
Conditions
Keywords
Infant weight gain, Human milk fortifier, Preterm infants, ELBW infants
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTHuman milk fortifier based on human milk (Prolacta)
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
Sponsors
Paracelsus Medical University
Medical University of Vienna
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Days to 8 Weeks
Healthy volunteers
No
Inclusion criteria
* Preterm infants with a birth weight \<1000 g
Exclusion criteria
* Congenital heart disease * Major congenital birth defects * Major inborn error of metabolism
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| growth velocity g/kg/d at 37+0 weeks | at 37+0 weeks of gestation | weight gain in g/kg/d |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| growth velocity g/kg/d from start of fortification to 32+0 weeks | at 32+0 weeks of gestation | weight gain in g/kg/d |
| Weight at 32+0 | at 32 weeks of gestation | weight in grams |
| Weight at 37+0 | at 37+0 weeks of gestation | weight in grams |
| Length at 32+0 | at 32+0 weeks of gestation | Length in cm |
| Length gain at 32+0 | at 32+0 weeks of gestation | Length gain in cm/week |
| Head circumference at 32+0 | at 32+0 weeks of gestation | head circumference in cm |
| Head circumference gain at 32+0 | at 32+0 weeks of gestation | head circumference gain in cm/week |
| Length at 37+0 | at 37 weeks of gestation | Length in cm |
| Lengthgain at 37+0 | at 37 weeks of gestation | Lengthgain in cm/week |
| growth velocity g/kg/d at 32+0 weeks | at 32+0 weeks of gestation | weight gain in g/kg/d |
| Head circumference gain at 37+0 | at 37 weeks of gestation | Head circumference gain in cm/week |
| Time to full enteral feeds | up to 37 weeks of gestation | Day of life when full enteral feeds (140ml/kg) are tolerated |
| Incidence of necrotising enterocolitis | up to 37 weeks of gestation | Necrotizing enterocolitis stage 2a according to Bell |
| Body composition | up to 6 months corrected for prematurity | Fat and Fat- free mass measured by Body plethysmography |
| Blood parameter total protein | up to 37 weeks of gestation | laboratory parameter |
| Blood parameter Urea | up to 37 weeks of gestation | laboratory parameter |
| Blood parameter Triglyceride | up to 37 weeks of gestation | laboratory parameter |
| Blood parameter Glucose | up to 37 weeks of gestation | laboratory parameter |
| z- scores | at 37 weeks of gestation | z-scores for weight , length and head circumference |
| Head circumference at 37+0 | at 37 weeks of gestation | Head circumference in cm |
Countries
Austria
Outcome results
None listed