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

Medical University of Vienna

Status: Completed

Conditions: Human Milk; Extremely Low Birth Weight; Weight Gain; Preterm Infants

Treatments: Dietary Supplement: Human milk fortifier based on human milk (Prolacta)

Study type: Observational

Funder types: Other

Identifiers

NCT03886844

Prolacta

Details and patient eligibility

About

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.

Full 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.

Enrollment: 196 patients

Sex: All

Ages: 1 day to 8 weeks old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Preterm infants with a birth weight <1000 g

Exclusion criteria

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

Trial design

196 participants in 2 patient groups

Prolacta group

Description:

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

Treatment:

Dietary Supplement: Human milk fortifier based on human milk (Prolacta)

"Frauenmilch Supplement"=FMS group

Description:

Infants, who received a human milk fortifier based on bovine milk (05/2012-06/2015), started with an enteral intake of 100 ml/kg