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

Weight Gain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03886844
• Other study ID #: Prolacta
• Status: Completed
• Start date: December 2015
• Est. completion date: November 2018

Study information

• Verified date: April 2019
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 196
• Est. completion date: November 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 8 Weeks

Eligibility

Inclusion Criteria:

• Preterm infants with a birth weight <1000 g

Exclusion Criteria:

• Congenital heart disease

• Major congenital birth defects

• Major inborn error of metabolism

Related Conditions & MeSH terms

• Birth Weight
• Body Weight
• Extremely Low Birth Weight
• Human Milk
• Preterm Infants
• Weight Gain

Intervention

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

Locations

Country	Name	City	State
Austria	Paracelsus Medical University	Salzburg
Austria	Medical University of Vienna	Vienna

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Vienna	Paracelsus Medical University

Country where clinical trial is conducted

Austria, 

Outcome

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