Clinical trial NCT03886844: Growth and Weight Gain in ELBW Infants Fed an Exclusively Human Milk Based Diet With Prolacta®
Official title: Prolacta Compare. Growth and Weight Gain in Extremely Low Birth Weight Infants Fed an Exclusively Human Milk Based Diet With Prolacta®
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Weight Gain
Human Milk
Preterm Infants
Extremely Low Birth Weight
Keywords: Infant weight gain
Human milk fortifier
Preterm infants
ELBW infants
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
Collaborators: name: Paracelsus Medical University
First posted: 2019-03-22
Enrollment: 196
Sex: ALL
Minimum age (years): 1
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: ELBW infants (extremely low birth weight infants, \<1000g birth weight)

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.

Eligibility criteria: Inclusion Criteria:

* Preterm infants with a birth weight \<1000 g

Exclusion Criteria:

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

Primary outcomes:
measure: growth velocity g/kg/d at 37+0 weeks
timeFrame: at 37+0 weeks of gestation
Secondary outcomes:
measure: growth velocity g/kg/d at 32+0 weeks
timeFrame: at 32+0 weeks of gestation
measure: growth velocity g/kg/d from start of fortification to 32+0 weeks
timeFrame: at 32+0 weeks of gestation
measure: Weight at 32+0
timeFrame: at 32 weeks of gestation
measure: Weight at 37+0
timeFrame: at 37+0 weeks of gestation
measure: Length at 32+0
timeFrame: at 32+0 weeks of gestation
measure: Length gain at 32+0
timeFrame: at 32+0 weeks of gestation
measure: Head circumference at 32+0
timeFrame: at 32+0 weeks of gestation
measure: Head circumference gain at 32+0
timeFrame: at 32+0 weeks of gestation
measure: Length at 37+0
timeFrame: at 37 weeks of gestation
measure: Lengthgain at 37+0
timeFrame: at 37 weeks of gestation
measure: Head circumference at 37+0
timeFrame: at 37 weeks of gestation
measure: Head circumference gain at 37+0
timeFrame: at 37 weeks of gestation
measure: Time to full enteral feeds
timeFrame: up to 37 weeks of gestation
measure: Incidence of necrotising enterocolitis
timeFrame: up to 37 weeks of gestation
measure: Body composition
timeFrame: up to 6 months corrected for prematurity
measure: Blood parameter total protein
timeFrame: up to 37 weeks of gestation
measure: Blood parameter Urea
timeFrame: up to 37 weeks of gestation
measure: Blood parameter Triglyceride
timeFrame: up to 37 weeks of gestation
measure: Blood parameter Glucose
timeFrame: up to 37 weeks of gestation
measure: z- scores
timeFrame: at 37 weeks of gestation
Other outcomes:
Locations:
city: Salzburg
country: Austria
facility: Paracelsus Medical University
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna
name: Assoc. Prof. PD. Nadja Haiden, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: