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

Completed

• Conditions: Preterm Infants; Extremely Low Birth Weight; Human Milk; Weight Gain
• Interventions: Dietary Supplement: Human milk fortifier based on human milk (Prolacta)

• Registration Number: NCT03886844
• Lead Sponsor: Medical University of Vienna

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.

Study Timeline

• Study Start: 2015-12
• Primary Completion: 2018-11
• Study Completion: 2018-11
• Study First Submitted: 2019-03-19
• Study First Submitted QC: 2019-03-21
• Study First Posted: 2019-03-22
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-25
• Last Update Posted: 2019-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 196

Inclusion Criteria

• Preterm infants with a birth weight <1000 g

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Exclusion Criteria

• Congenital heart disease
• Major congenital birth defects
• Major inborn error of metabolism

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Prolacta group	Human milk fortifier based on human milk (Prolacta)	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

Primary Outcome Measures

Name	Time	Method
growth velocity g/kg/d at 37+0 weeks	at 37+0 weeks of gestation	weight gain in g/kg/d

Secondary Outcome Measures

Name	Time	Method
Length gain at 32+0	at 32+0 weeks of gestation	Length gain in cm/week
Blood parameter Urea	up to 37 weeks of gestation	laboratory parameter
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
growth velocity g/kg/d at 32+0 weeks	at 32+0 weeks of gestation	weight gain in g/kg/d
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
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
Weight at 32+0	at 32 weeks of gestation	weight in grams
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
Head circumference at 32+0	at 32+0 weeks of gestation	head circumference in cm
Lengthgain at 37+0	at 37 weeks of gestation	Lengthgain in cm/week
Head circumference at 37+0	at 37 weeks of gestation	Head circumference in cm
Head circumference gain at 37+0	at 37 weeks of gestation	Head circumference gain in cm/week
Blood parameter total protein	up to 37 weeks of gestation	laboratory parameter
Body composition	up to 6 months corrected for prematurity	Fat and Fat- free mass measured by Body plethysmography
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

Trial Locations

Locations (2)

Paracelsus Medical University; 🇦🇹 Salzburg, Austria

Medical University of Vienna; 🇦🇹 Vienna, Austria