Growth and Weight Gain in ELBW Infants Fed an Exclusively Human Milk Based Diet With Prolacta®

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prolacta Compare. Growth and Weight Gain in Extremely Low Birth Weight Infants Fed an Exclusively Human Milk Based Diet With Prolacta®

Conditions
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Weight Gain, Human Milk, Preterm Infants, Extremely Low Birth Weight

Intervention / Treatment
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* Dietary Supplement: Human milk fortifier based on human milk (Prolacta)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Preterm infants with a birth weight <1000 g Exclusion Criteria: Congenital heart disease Major congenital birth defects Major inborn error of metabolism

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 8 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Prolacta group<br>Infants, who received a human milk fortifier based on human milk (12/2015-11/2018), started with an enteral intake of 100 ml/kg until 32 weeks corrected for prematurity | Dietary Supplement: Human milk fortifier based on human milk (Prolacta)<br>* 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<br>|
| Frauenmilch Supplement=FMS group<br>Infants, who received a human milk fortifier based on bovine milk (05/2012-06/2015), started with an enteral intake of 100 ml/kg | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| growth velocity g/kg/d at 37+0 weeks | weight gain in g/kg/d | at 37+0 weeks of gestation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| growth velocity g/kg/d at 32+0 weeks | weight gain in g/kg/d | 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 | at 32+0 weeks of gestation | 
| Weight at 32+0 | weight in grams | at 32 weeks of gestation | 
| Weight at 37+0 | weight in grams | at 37+0 weeks of gestation | 
| Length at 32+0 | Length in cm | at 32+0 weeks of gestation | 
| Length gain at 32+0 | Length gain in cm/week | at 32+0 weeks of gestation | 
| Head circumference at 32+0 | head circumference in cm | at 32+0 weeks of gestation | 
| Head circumference gain at 32+0 | head circumference gain in cm/week | at 32+0 weeks of gestation | 
| Length at 37+0 | Length in cm | at 37 weeks of gestation | 
| Lengthgain at 37+0 | Lengthgain in cm/week | at 37 weeks of gestation | 
| Head circumference at 37+0 | Head circumference in cm | at 37 weeks of gestation | 
| Head circumference gain at 37+0 | Head circumference gain in cm/week | at 37 weeks of gestation | 
| Time to full enteral feeds | Day of life when full enteral feeds (140ml/kg) are tolerated | up to 37 weeks of gestation | 
| Incidence of necrotising enterocolitis | Necrotizing enterocolitis stage 2a according to Bell | up to 37 weeks of gestation | 
| Body composition | Fat and Fat- free mass measured by Body plethysmography | up to 6 months corrected for prematurity | 
| Blood parameter total protein | laboratory parameter | up to 37 weeks of gestation | 
| Blood parameter Urea | laboratory parameter | up to 37 weeks of gestation | 
| Blood parameter Triglyceride | laboratory parameter | up to 37 weeks of gestation | 
| Blood parameter Glucose | laboratory parameter | up to 37 weeks of gestation | 
| z- scores | z-scores for weight , length and head circumference | at 37 weeks of gestation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infant weight gain, Human milk fortifier, Preterm infants, ELBW infants