Optimal Growth of Preterm Infants With Growth Restriction

NCT02999945 | Withdrawn DMC

• 1 other identifier: OPTIGROW
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

preterm infants; SGA infants; IUGR infants; growth; body composition; metabolomics; microbiome; adiposity markers; metabolic programming; neurodevelopmental outcome

Outcome Measures

Primary Outcomes (1)

• Fat Free Mass

  Fat free mass measured by body plethysmography

  3 months

Secondary Outcomes (15)

• anthropometry-length

  24 months

• anthropometry-weight

  24 months

• anthropometry-HC

  24 months

• anthropometry-z-score

  24 months

• parameters of metabolic programming- IGF1

  12 months

Study Arms (4)

SGA-enhanced nutrients

ACTIVE COMPARATOR

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: SGA-enhanced nutrients

SGA-standard nutrients

OTHER

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: SGA-standard nutrients

IUGR-enhanced nutrients

ACTIVE COMPARATOR

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

IUGR-standard nutrients

OTHER

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

Interventions

SGA-enhanced nutrients DIETARY_SUPPLEMENT

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

SGA-enhanced nutrients

IUGR-enhanced nutrients DIETARY_SUPPLEMENT

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

IUGR-enhanced nutrients

SGA-standard nutrients OTHER

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)

SGA-standard nutrients

IUGR-standard nutrients OTHER

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)

IUGR-standard nutrients

Eligibility Criteria

• Age: Up to 42 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Preterm infants with a birth weight \<1500g and birth weight \<10th percentile.
• Weight at term \<10th percentile
• Informed consent

You may not qualify if:

• Genetic or metabolic diseases with the primary effect on growth
• Necrotizing enterocolitis
• Intraventricular hemorrhage (IVH) \>Grade II
• Periventricular leukomalacia (PVL) Stage III
• Genetic or metabolic disorders
• Bronchopulmonary dysplasia

Sponsors & Collaborators

• Medical University of Vienna: lead
• Medical University of Graz: collaborator
• Ludwig-Maximilians - University of Munich: collaborator
• University Hospital Tuebingen: collaborator
• University of Erlangen-Nürnberg Medical School: collaborator
• University of Milan: collaborator
• Poznan University of Medical Sciences: collaborator
• Lund University: collaborator

MeSH Terms

Conditions

Failure to Thrive; Obesity; Diabetes Mellitus; Neurologic Manifestations

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Nervous System Diseases

Study Officials

• Nadja Haiden, MD

  MUW

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Dr.

Study Record Dates

• First Submitted: December 5, 2016
• First Posted: December 21, 2016
• Study Start: March 1, 2019
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2022
• Last Updated: March 21, 2019

Record last verified: 2019-03