Optimal Growth of Preterm Infants With Growth Restriction

Summary

In this prospective randomized controlled multi center trial the investigators stratify "Very Low Birthweight " (VLBW)-infants with growth retardation in small for gestational age (SGA) or intrauterine growth restricted (IUGR) - infants and aim to investigate the impact of a nutritional management with enhanced nutrients from discharge up to the 52nd week of postconceptional age on growth, body composition, metabolic programming, metabolomics, microbiome and long term neurodevelopmental outcome. In this study, the investigators will evaluate the difference in metabolic profiles of SGA and IUGR preterm infants. The investigators will further longitudinally assess, how different nutritional interventions affect the altered pathways in the first year of life and identify, in combination with data available from metabolic markers, microbiome and breast milk analysis, potential pathways resulting in increased disease risk later in life.

Conditions

• Growth Failure
• Adiposity
• Diabetes
• Neurologic Deficits

Interventions

DIETARY_SUPPLEMENT

SGA-enhanced nutrients

Infants will receive fortified breast milk (\>50% meals/d fortified, 1,4 g protein, 85 kcal/100ml, FM85, Nestle ®) or post discharge formula (2g protein; 73-75 kcal/100ml; Aptamil PDF, Milupa® or Beba F Nestle® ) between discharge and 52nd week of gestation (three months after term

DIETARY_SUPPLEMENT

IUGR-enhanced nutrients

Infants will receive fortified breast milk (\>50% meals/d fortified, 1,4 g protein, 85 kcal/100ml, FM85, Nestle ®) or post discharge formula (2g protein; 73-75 kcal/100ml; Aptamil PDF, Milupa® or Beba F Nestle® ) between discharge and 52nd week of gestation (three months after term

OTHER

SGA-standard nutrients

Infants will receive unfortified breast milk (65-70kcal/100ml) or starter formula (1,2- 1,3g protein, 66 kcal/100ml Beba Pre Pro Start, Nestle® or Aptamil Pre, Milupa ®) between discharge and 52nd week of gestation (three months after term)

OTHER

IUGR-standard nutrients

Infants will receive unfortified breast milk (65-70kcal/100ml) or starter formula (1,2- 1,3g protein, 66 kcal/100ml Beba Pre Pro Start, Nestle® or Aptamil Pre, Milupa ®) between discharge and 52nd week of gestation (three months after term)

Sponsors & Collaborators

• Medical University of Graz

  collaborator OTHER

• Ludwig-Maximilians - University of Munich

  collaborator OTHER

• University Hospital Tuebingen

  collaborator OTHER

• University of Erlangen-Nürnberg Medical School

  collaborator OTHER

• University of Milan

  collaborator OTHER

• Poznan University of Medical Sciences

  collaborator OTHER

• Lund University

  collaborator OTHER

• Medical University of Vienna

  lead OTHER

Principal Investigators

• Nadja Haiden, MD · MUW

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Max Age

42 Weeks

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-03-31

Primary Completion

2020-01-31

Completion

2022-01-31