Skip to main content
OpenTrials
Completed

NCT Number: NCT03886844

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Weight Gain Body Weight Body Weight Changes Extremely Low Birth Weight Human Milk Pathological Conditions, Signs and Symptoms Preterm Infants Signs and Symptoms

Age range

1 day–8 week

Sex eligibility

All sexes

Study type

Observational

Primary location

Paracelsus Medical University, Salzburg, Austria

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Preterm infants with a birth weight <1000 g

Exclusion criteria

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

Treatment and study plan

Human milk fortifier based on human milk (Prolacta)

Dietary Supplement

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

Primary outcomes

  1. growth velocity g/kg/d at 37+0 weeks

    Time frame: at 37+0 weeks of gestation

    weight gain in g/kg/d

Secondary outcomes

  1. growth velocity g/kg/d at 32+0 weeks

    Time frame: at 32+0 weeks of gestation

    weight gain in g/kg/d

  2. growth velocity g/kg/d from start of fortification to 32+0 weeks

    Time frame: at 32+0 weeks of gestation

    weight gain in g/kg/d

  3. Weight at 32+0

    Time frame: at 32 weeks of gestation

    weight in grams

  4. Weight at 37+0

    Time frame: at 37+0 weeks of gestation

    weight in grams

  5. Length at 32+0

    Time frame: at 32+0 weeks of gestation

    Length in cm

  6. Length gain at 32+0

    Time frame: at 32+0 weeks of gestation

    Length gain in cm/week

  7. Head circumference at 32+0

    Time frame: at 32+0 weeks of gestation

    head circumference in cm

  8. Head circumference gain at 32+0

    Time frame: at 32+0 weeks of gestation

    head circumference gain in cm/week

  9. Length at 37+0

    Time frame: at 37 weeks of gestation

    Length in cm

  10. Lengthgain at 37+0

    Time frame: at 37 weeks of gestation

    Lengthgain in cm/week

  11. Head circumference at 37+0

    Time frame: at 37 weeks of gestation

    Head circumference in cm

  12. Head circumference gain at 37+0

    Time frame: at 37 weeks of gestation

    Head circumference gain in cm/week

  13. Time to full enteral feeds

    Time frame: up to 37 weeks of gestation

    Day of life when full enteral feeds (140ml/kg) are tolerated

  14. Incidence of necrotising enterocolitis

    Time frame: up to 37 weeks of gestation

    Necrotizing enterocolitis stage 2a according to Bell

  15. Body composition

    Time frame: up to 6 months corrected for prematurity

    Fat and Fat- free mass measured by Body plethysmography

  16. Blood parameter total protein

    Time frame: up to 37 weeks of gestation

    laboratory parameter

  17. Blood parameter Urea

    Time frame: up to 37 weeks of gestation

    laboratory parameter

  18. Blood parameter Triglyceride

    Time frame: up to 37 weeks of gestation

    laboratory parameter

  19. Blood parameter Glucose

    Time frame: up to 37 weeks of gestation

    laboratory parameter

  20. z- scores

    Time frame: at 37 weeks of gestation

    z-scores for weight , length and head circumference

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Collaborators

  • Paracelsus Medical University

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Mar 22, 2019
Registry last updated
Apr 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.