<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02999945</url>
  </required_header>
  <id_info>
    <org_study_id>OPTIGROW</org_study_id>
    <nct_id>NCT02999945</nct_id>
  </id_info>
  <brief_title>Optimal Growth of Preterm Infants With Growth Restriction</brief_title>
  <acronym>OPTIGROW</acronym>
  <official_title>Body Composition, Metabolic Programming and Long Term Outcome of Growth Restricted Preterm Infants Under Different Nutritional Management A Prospective Randomized Controlled Multicenter Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Vienna</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Medical University of Graz</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ludwig-Maximilians - University of Munich</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital Tuebingen</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Erlangen-Nürnberg Medical School</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Milan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Poznan University of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Lund University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Medical University of Vienna</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this prospective randomized controlled multi center trial the investigators stratify &quot;Very&#xD;
      Low Birthweight &quot; (VLBW)-infants with growth retardation in small for gestational age (SGA)&#xD;
      or intrauterine growth restricted (IUGR) - infants and aim to investigate the impact of a&#xD;
      nutritional management with enhanced nutrients from discharge up to the 52nd week of&#xD;
      postconceptional age on growth, body composition, metabolic programming, metabolomics,&#xD;
      microbiome and long term neurodevelopmental outcome. In this study, the investigators will&#xD;
      evaluate the difference in metabolic profiles of SGA and IUGR preterm infants. The&#xD;
      investigators will further longitudinally assess, how different nutritional interventions&#xD;
      affect the altered pathways in the first year of life and identify, in combination with data&#xD;
      available from metabolic markers, microbiome and breast milk analysis, potential pathways&#xD;
      resulting in increased disease risk later in life.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prematurity is the leading cause for mortality and morbidity in newborns with very low birth&#xD;
      weight (VLBW) infants (&lt; 1500g birth weight) at highest risk. Ten to thirty percent of VLBW&#xD;
      infants are also born too small for their gestational age defined by a birth weight below the&#xD;
      10th percentile. In daily neonatal intensive care, consequential long term-follow up and most&#xD;
      studies all growth restricted premature infants are treated the same, importantly this&#xD;
      includes the nutritional management after birth. However, different groups of patients with&#xD;
      different causal pathologies are subsumed under the definition growth restriction or born too&#xD;
      small. One group of growth restricted patients refers to the infants born constitutionally&#xD;
      small or small for gestational age (SGA). The other group refers to infants with an&#xD;
      intrauterine growth restriction (IUGR) caused by a complex antenatal pathology. Consequently,&#xD;
      the nutritional management after birth is very important to minimize the potential risk for&#xD;
      developing obesity, diabetes and cardiovascular diseases later in life and to achieve optimal&#xD;
      growth. So far we do not consider the different underlying pathomechanisms of growth&#xD;
      restriction in our nutritional concepts for preterm infants and therefore cause long-term&#xD;
      consequences. The European society of pediatric gastroenterology, hematology and nutrition&#xD;
      (ESPGHAN) recommends to feed enhanced nutrients up to 52nd week of gestation in all growth&#xD;
      restricted preterm infants- regardless if they are SGA or IUGR premature. Actually, reliable&#xD;
      data guaranteeing that the recommended &quot;enhanced nutrients strategy&quot; providing extra&#xD;
      nutrients up to 52 weeks for SGA and IUGR infants is safe and effective for both groups in&#xD;
      terms of long-term growth and metabolic programming are lacking.&#xD;
&#xD;
      A total of 348 preterm infants born and discharged below the 10th percentile at term will be&#xD;
      included in the study and stratified according to SGA or IUGR by a combination of antenatal&#xD;
      ultrasound parameters and growth parameters (including 10% screening failures and 20% drop&#xD;
      out. Furthermore IUGR and SGA growth restricted preterm infants will be stratified according&#xD;
      to breastfeeding or formula feeding and randomized in one of the following groups: Standard&#xD;
      nutrients group (breastfeeding or starter formula) or Enhanced nutrients group (fortified&#xD;
      breast milk or post-discharge formula. Body composition measurements will be performed by air&#xD;
      displacement plethysmography - a non-invasive method. Anthropometric measurements will be&#xD;
      performed by measuring weight, height and head circumference. Furthermore, parameters of&#xD;
      metabolic programming, metabolomics, the stool microbiome and neurodevelopmental outcome will&#xD;
      be determined. Additionally, the stool microbiome will be characterized from infant stool&#xD;
      samples and compared between the two groups. After an interventional period of three months&#xD;
      infants will be followed up until 2 years of age.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    no funding&#xD;
  </why_stopped>
  <start_date type="Anticipated">March 2019</start_date>
  <completion_date type="Anticipated">January 2022</completion_date>
  <primary_completion_date type="Anticipated">January 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Fat Free Mass</measure>
    <time_frame>3 months</time_frame>
    <description>Fat free mass measured by body plethysmography</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>anthropometry-length</measure>
    <time_frame>24 months</time_frame>
    <description>length in cm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>anthropometry-weight</measure>
    <time_frame>24 months</time_frame>
    <description>weight in grams</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>anthropometry-HC</measure>
    <time_frame>24 months</time_frame>
    <description>head circumference in cm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>anthropometry-z-score</measure>
    <time_frame>24 months</time_frame>
    <description>z-scores</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>parameters of metabolic programming- IGF1</measure>
    <time_frame>12 months</time_frame>
    <description>IGF-1in ng/ml</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>parameters of metabolic programming-IGF3</measure>
    <time_frame>12 months</time_frame>
    <description>IGF-3 in ng/ml</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>parameters of metabolic programming-IGF-BP</measure>
    <time_frame>12 months</time_frame>
    <description>IGF-BP in ng/ml</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>parameters of metabolic programming-Leptin</measure>
    <time_frame>12 months</time_frame>
    <description>Leptin in ng/ml</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>parameters of metabolic programming-Adiponectin</measure>
    <time_frame>12 months</time_frame>
    <description>Adiponectin in mcg/ml</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>neurodevelopmental outcome</measure>
    <time_frame>24months</time_frame>
    <description>Bayley scales</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>metabolomics</measure>
    <time_frame>12 months</time_frame>
    <description>Metabolomic analysis will determine around 200 metabolites covering polar lipids (SOFIA), acylcarnitines (CARN), non-esterified fatty acids (NEFA) and amino acids (AA). Data will be acquired according to retention time and mass transition on triple quadrupole mass spectrometer, controlled by Analyst.&#xD;
All metabolite concentrations are reported in µmol/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>stool microbiome</measure>
    <time_frame>24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>macronutrients in breastmilk-fat</measure>
    <time_frame>6 months</time_frame>
    <description>Fat will be analysed by modified Mojonnierether extraction (g/100ml)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>macronutrients in breastmilk-Lactose</measure>
    <time_frame>6 months</time_frame>
    <description>Lactose will be determined by Lactose analysis method: LC-MS/MS (g/100ml)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>macronutrients in breastmilk-protein</measure>
    <time_frame>6 months</time_frame>
    <description>Protein will be determined by elemental analysis (g/100ml)</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Growth Failure</condition>
  <condition>Adiposity</condition>
  <condition>Diabetes</condition>
  <condition>Neurologic Deficits</condition>
  <arm_group>
    <arm_group_label>SGA-enhanced nutrients</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Infants will receive fortified breast milk (&gt;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)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SGA-standard nutrients</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>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).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IUGR-enhanced nutrients</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Infants will receive fortified breast milk (&gt;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</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IUGR-standard nutrients</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>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).</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>SGA-enhanced nutrients</intervention_name>
    <description>Infants will receive fortified breast milk (&gt;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</description>
    <arm_group_label>SGA-enhanced nutrients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>IUGR-enhanced nutrients</intervention_name>
    <description>Infants will receive fortified breast milk (&gt;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</description>
    <arm_group_label>IUGR-enhanced nutrients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>SGA-standard nutrients</intervention_name>
    <description>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)</description>
    <arm_group_label>SGA-standard nutrients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>IUGR-standard nutrients</intervention_name>
    <description>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)</description>
    <arm_group_label>IUGR-standard nutrients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Preterm infants with a birth weight &lt;1500g and birth weight &lt;10th percentile.&#xD;
&#xD;
          -  Weight at term &lt;10th percentile&#xD;
&#xD;
          -  Informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Genetic or metabolic diseases with the primary effect on growth&#xD;
&#xD;
          -  Necrotizing enterocolitis&#xD;
&#xD;
          -  Intraventricular hemorrhage (IVH) &gt;Grade II&#xD;
&#xD;
          -  Periventricular leukomalacia (PVL) Stage III&#xD;
&#xD;
          -  Genetic or metabolic disorders&#xD;
&#xD;
          -  Bronchopulmonary dysplasia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>42 Weeks</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nadja Haiden, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>MUW</affiliation>
  </overall_official>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>December 5, 2016</study_first_submitted>
  <study_first_submitted_qc>December 17, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 21, 2016</study_first_posted>
  <last_update_submitted>March 19, 2019</last_update_submitted>
  <last_update_submitted_qc>March 19, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 21, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Vienna</investigator_affiliation>
    <investigator_full_name>Nadja Haiden,MD</investigator_full_name>
    <investigator_title>Assoc. Prof. Dr.</investigator_title>
  </responsible_party>
  <keyword>preterm infants</keyword>
  <keyword>SGA infants</keyword>
  <keyword>IUGR infants</keyword>
  <keyword>growth</keyword>
  <keyword>body composition</keyword>
  <keyword>metabolomics</keyword>
  <keyword>microbiome</keyword>
  <keyword>adiposity markers</keyword>
  <keyword>metabolic programming</keyword>
  <keyword>neurodevelopmental outcome</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neurologic Manifestations</mesh_term>
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Failure to Thrive</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02999945
org study id: OPTIGROW
nct id: NCT02999945
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
Prematurity is the leading cause for mortality and morbidity in newborns with very low birth
      weight (VLBW) infants (< 1500g birth weight) at highest risk. Ten to thirty percent of VLBW
      infants are also born too small for their gestational age defined by a birth weight below the
      10th percentile. In daily neonatal intensive care, consequential long term-follow up and most
      studies all growth restricted premature infants are treated the same, importantly this
      includes the nutritional management after birth. However, different groups of patients with
      different causal pathologies are subsumed under the definition growth restriction or born too
      small. One group of growth restricted patients refers to the infants born constitutionally
      small or small for gestational age (SGA). The other group refers to infants with an
      intrauterine growth restriction (IUGR) caused by a complex antenatal pathology. Consequently,
      the nutritional management after birth is very important to minimize the potential risk for
      developing obesity, diabetes and cardiovascular diseases later in life and to achieve optimal
      growth. So far we do not consider the different underlying pathomechanisms of growth
      restriction in our nutritional concepts for preterm infants and therefore cause long-term
      consequences. The European society of pediatric gastroenterology, hematology and nutrition
      (ESPGHAN) recommends to feed enhanced nutrients up to 52nd week of gestation in all growth
      restricted preterm infants- regardless if they are SGA or IUGR premature. Actually, reliable
      data guaranteeing that the recommended "enhanced nutrients strategy" providing extra
      nutrients up to 52 weeks for SGA and IUGR infants is safe and effective for both groups in
      terms of long-term growth and metabolic programming are lacking.

      A total of 348 preterm infants born and discharged below the 10th percentile at term will be
      included in the study and stratified according to SGA or IUGR by a combination of antenatal
      ultrasound parameters and growth parameters (including 10% screening failures and 20% drop
      out. Furthermore IUGR and SGA growth restricted preterm infants will be stratified according
      to breastfeeding or formula feeding and randomized in one of the following groups: Standard
      nutrients group (breastfeeding or starter formula) or Enhanced nutrients group (fortified
      breast milk or post-discharge formula. Body composition measurements will be performed by air
      displacement plethysmography - a non-invasive method. Anthropometric measurements will be
      performed by measuring weight, height and head circumference. Furthermore, parameters of
      metabolic programming, metabolomics, the stool microbiome and neurodevelopmental outcome will
      be determined. Additionally, the stool microbiome will be characterized from infant stool
      samples and compared between the two groups. After an interventional period of three months
      infants will be followed up until 2 years of age.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Fat Free Mass
time frame: 3 months
description: Fat free mass measured by body plethysmography
measure: anthropometry-length
time frame: 24 months
description: length in cm
measure: anthropometry-weight
time frame: 24 months
description: weight in grams
measure: anthropometry-HC
time frame: 24 months
description: head circumference in cm
measure: anthropometry-z-score
time frame: 24 months
description: z-scores
measure: parameters of metabolic programming- IGF1
time frame: 12 months
description: IGF-1in ng/ml
measure: parameters of metabolic programming-IGF3
time frame: 12 months
description: IGF-3 in ng/ml
measure: parameters of metabolic programming-IGF-BP
time frame: 12 months
description: IGF-BP in ng/ml
measure: parameters of metabolic programming-Leptin
time frame: 12 months
description: Leptin in ng/ml
measure: parameters of metabolic programming-Adiponectin
time frame: 12 months
description: Adiponectin in mcg/ml
measure: neurodevelopmental outcome
time frame: 24months
description: Bayley scales
measure: metabolomics
time frame: 12 months
description: Metabolomic analysis will determine around 200 metabolites covering polar lipids (SOFIA), acylcarnitines (CARN), non-esterified fatty acids (NEFA) and amino acids (AA). Data will be acquired according to retention time and mass transition on triple quadrupole mass spectrometer, controlled by Analyst.
All metabolite concentrations are reported in µmol/L
measure: stool microbiome
time frame: 24 months
measure: macronutrients in breastmilk-fat
time frame: 6 months
description: Fat will be analysed by modified Mojonnierether extraction (g/100ml)
measure: macronutrients in breastmilk-Lactose
time frame: 6 months
description: Lactose will be determined by Lactose analysis method: LC-MS/MS (g/100ml)
measure: macronutrients in breastmilk-protein
time frame: 6 months
description: Protein will be determined by elemental analysis (g/100ml)
arm group label: SGA-enhanced nutrients
arm group type: Active Comparator
description: 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)
arm group label: SGA-standard nutrients
arm group type: Other
description: 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).
arm group label: IUGR-enhanced nutrients
arm group type: Active Comparator
description: 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
arm group label: IUGR-standard nutrients
arm group type: Other
description: 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).
intervention type: Dietary Supplement
intervention name: SGA-enhanced nutrients
description: 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
arm group label: SGA-enhanced nutrients
intervention type: Dietary Supplement
intervention name: IUGR-enhanced nutrients
description: 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
arm group label: IUGR-enhanced nutrients
intervention type: Other
intervention name: SGA-standard nutrients
description: 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)
arm group label: SGA-standard nutrients
intervention type: Other
intervention name: IUGR-standard nutrients
description: 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)
arm group label: IUGR-standard nutrients
criteria: 
gender: All
minimum age: N/A
maximum age: 42 Weeks
healthy volunteers: Accepts Healthy Volunteers
last name: Nadja Haiden, MD
role: Principal Investigator
affiliation: MUW
responsible party type: Principal Investigator
investigator affiliation: Medical University of Vienna
investigator full name: Nadja Haiden,MD
investigator title: Assoc. Prof. Dr.
mesh term: Neurologic Manifestations
mesh term: Obesity
mesh term: Failure to Thrive
sharing ipd: Undecided