<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/NCT04400396</url>
  </required_header>
  <id_info>
    <org_study_id>CHULC.CI512.2020</org_study_id>
    <nct_id>NCT04400396</nct_id>
  </id_info>
  <brief_title>Effect of Target Fortified Human Milk on the Growth Quality of Very Preterm Infants (TargetFort)</brief_title>
  <acronym>TargetFort</acronym>
  <official_title>Effect of Target vs. Standard Human Milk Fortification on the Growth and Body Composition of Predominantly Human Milk Fed Very Preterm Infants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centro Hospitalar de Lisboa Central</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sociedade Portuguesa de Neonatologia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Centro Hospitalar de Lisboa Central</source>
  <oversight_info>
    <has_dmc>No</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>
      It is reported that the standard method for fortification of human milk (HM) overestimates&#xD;
      the energy and protein densities of HM (Macedo MHNP 2018), thus originating infant&#xD;
      undernutrition (Macedo AJP 2018). The target fortification, based on analysis of HM&#xD;
      composition, is considered the gold-standard method (Rochow 2015, McLeod 2016). This&#xD;
      observational mixed cohort study aims to assess if very preterm infants fed HM with target&#xD;
      fortification have greater growth during hospital stay and better body composition at term&#xD;
      post-menstrual age (PMA), than those fed HM with standard fortification.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study design: observational mixed cohort study, comparing growth and body composition in a&#xD;
      contemporary cohort of very preterm infants fed HM with target fortification, the currently&#xD;
      adopted clinical practice, with a historical cohort of very preterm infants fed HM with&#xD;
      standard fortification (Macedo AJP 2018).&#xD;
&#xD;
      Study periods: historical cohort from 1 February 2014 to 28 February 2015; contemporary&#xD;
      cohort: start February 2020, estimated recruitment period of 16 months; Settings: Neonatal&#xD;
      Care Unit (NICU) and Human Milk Bank at Maternidade Dr. Alfredo da Costa and Nutrition&#xD;
      Laboratory at Hospital Dona Estefânia, Centro Hospitalar Universitário de Lisboa Central.&#xD;
&#xD;
      Product to be analyzed: HM, including mother's own milk (MOM) and donor's milk (DHM). Donor&#xD;
      HM is pasteurized using the Holder method (Peila 2016) which is adopted by the Human Milk&#xD;
      Bank of Maternidade Dr. Alfredo da Costa (Macedo MHNP 2018).&#xD;
&#xD;
      Demographic variables: Gestational age, sex, singleton or twin, birth weight, small-,&#xD;
      appropriate- or large-for-gestational age (&lt;3rd percentile, ≥3rd percentile and ≤97th&#xD;
      percentile, &gt;97th percentile, respectively) (Fenton 2013), severity index (SNAPPE II)&#xD;
      (Richardson 2001), use of prenatal corticosteroids, diagnosis of late sepsis (Modi 2009),&#xD;
      necrotizing enterocolitis (grade ≥ 3) (Bell 1971), intraperiventricular hemorrhage (grade ≥&#xD;
      3) (Papile 1978), multicystic periventricular leukomalacia (de Vries 1992), and chronic lung&#xD;
      disease (Becker 1984).&#xD;
&#xD;
      Method of collection and analysis of HM: as described in a previous study (Macedo MHNP 2018),&#xD;
      in order to minimize daily variability of breast milk composition, mothers are asked to save&#xD;
      milk collected through 24 hours in the same container. The HM composition (MOM and DHM) are&#xD;
      analyzed using the Miris human milk analyzer (Miris AB, Uppsala, Sweden), following the&#xD;
      method described in a previous study (Macedo MHNP 2018). The composition is expressed in&#xD;
      densities: Kcal/dL of energy and g/dl of fat, raw and true protein, carbohydrates and ashes.&#xD;
&#xD;
      Energy and macronutrient composition of the multi-component HM fortifier and modular protein&#xD;
      and fat supplements. For this purpose, an Excel program to calculate modular protein and fat&#xD;
      supplements to be added to fortified HM was developed and registered (Nona R, Cardoso M,&#xD;
      Portuguese Directorate of Intellectual Property Services, IGAC-DSPI, nº 480/2020, 26 February&#xD;
      2020).&#xD;
&#xD;
      Daily intakes of energy (Kcal/kg), protein (g/kg) and protein:energy ratio (P:E), based on&#xD;
      administered volume of milk (ml/kg).&#xD;
&#xD;
      Anthropometric and body composition measurements in infants: According to the previously&#xD;
      described method (Macedo AJP 2018), during the hospital stay, the same observer (MMC)&#xD;
      measures daily the body weight (allowing the calculation of weight gain velocity), and weekly&#xD;
      the length and the head circumference. Within the first week after discharge, body&#xD;
      composition will be assessed using displacement plethysmography, to evaluate fat mass (FM),&#xD;
      fat free mass (FFM), percentage of FM (%FM), percentage of FFM (%FFM) and FM index (FMI), as&#xD;
      described in a previous study (Macedo AJP 2018). Both FMI and %FM are used as indicators of&#xD;
      adiposity.&#xD;
&#xD;
      Estimate of sample size: The study sample size was calculated to detect a difference of 2&#xD;
      g/kg/day in growth velocity with a standard deviation 2.6 (Macedo, 2018; Tremblay, 2017) for&#xD;
      normally distributed variables, a significance level of 0.05, and an 80% power; thus, a&#xD;
      required sample of 67 infants (n1=33; n2+20%=34) was estimated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">February 1, 2020</start_date>
  <completion_date type="Anticipated">December 16, 2021</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>weight gain velocity rate</measure>
    <time_frame>from baseline (the first day of exclusive or predominantly feeding with fortified human milk) up to 40 weeks postmenstrual age or to home discharge, whatever comes first</time_frame>
    <description>average relative daily variation of body weight</description>
  </primary_outcome>
  <primary_outcome>
    <measure>length velocity rate</measure>
    <time_frame>from baseline (the first day of exclusive or predominantly feeding with fortified human milk) up to 40 weeks postmenstrual age or to home discharge, whatever comes first</time_frame>
    <description>average relative weekly variation of body length</description>
  </primary_outcome>
  <primary_outcome>
    <measure>head circumference velocity rate</measure>
    <time_frame>from baseline (the first day of exclusive or predominantly feeding with fortified human milk) up to 40 weeks postmenstrual age or to home discharge, whatever comes first</time_frame>
    <description>average relative weekly variation of head circumference</description>
  </primary_outcome>
  <primary_outcome>
    <measure>adiposity (fat mass index)</measure>
    <time_frame>A single measurement performed up to 10 days after home discharge</time_frame>
    <description>ratio of fat mass over squared body length</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>adiposity (fat mass percentage)</measure>
    <time_frame>A single measurement performed up to 10 days after home discharge</time_frame>
    <description>proportion of fat mass on total body mass</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Growth</condition>
  <condition>Body Composition</condition>
  <condition>Prematurity</condition>
  <condition>Breast Milk Collection</condition>
  <condition>Nutrient Deficiency</condition>
  <condition>Feeding Patterns</condition>
  <condition>Adiposity</condition>
  <arm_group>
    <arm_group_label>target HM fortification</arm_group_label>
    <description>Contemporary cohort fed HM with target fortification</description>
  </arm_group>
  <arm_group>
    <arm_group_label>standard HM fortification</arm_group_label>
    <description>Historical cohort fed HM with standard fortification</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>standard HM fortification</intervention_name>
    <description>Based on the assumed energy and macronutrient composition of HM, the commercial multi-component HM fortifier was added, in order to compensate identified nutritional deficits.</description>
    <arm_group_label>standard HM fortification</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>target HM fortification</intervention_name>
    <description>Based on the measured energy and macronutrient composition of HM, modular protein and fat supplements are added, in addition to the commercial multi-component HM fortifier, in order to correct identified specific nutritional deficits. For this purpose, an Excel program to calculate modular protein and fat supplements to be added to fortified HM was developed and registered (Nona R, Cardoso M, Portuguese Directorate of Intellectual Property Services, IGAC-DSPI, nº 480/2020, 26 February 2020)</description>
    <arm_group_label>target HM fortification</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Human milk (HM), including mother's own milk (MOM) and donor's milk (DHM).&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Very preterm newborn infants (born at &lt;33 weeks) that achieve full enteral feeding&#xD;
        exclusively or predominantly with human milk&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  newborn infants born at &lt;33 weeks of gestation,&#xD;
&#xD;
          -  admitted to the NICU of Maternidade Dr. Alfredo da Costa (inborns and outborns),&#xD;
&#xD;
          -  exclusively or predominantly HM fed (&gt;87.5% volume per day)&#xD;
&#xD;
          -  discharged alive.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  multiples of grade &gt;2&#xD;
&#xD;
          -  diagnosis of innate metabolism disorder,&#xD;
&#xD;
          -  fed with formula for &gt;12.5% of the daily volume intake for two or more consecutive&#xD;
             full days ,&#xD;
&#xD;
          -  discharge with transference to other hospital,&#xD;
&#xD;
          -  unavailable for body composition analysis after discharge.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Day</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Luis Pereira-da-Silva, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Universidade Nova de Lisboa</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centro Hospitalar Universitário de Lisboa Central</name>
      <address>
        <city>Lisboa</city>
        <zip>1150-199</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Portugal</country>
  </location_countries>
  <reference>
    <citation>Macedo I, Pereira-da-Silva L, Cardoso M. The fortification method relying on assumed human milk composition overestimates the actual energy and macronutrient intakes in very preterm infants. Matern Health Neonatol Perinatol. 2018 Sep 17;4:22. doi: 10.1186/s40748-018-0090-4. eCollection 2018.</citation>
    <PMID>30237896</PMID>
  </reference>
  <reference>
    <citation>McLeod G, Sherriff J, Hartmann PE, Nathan E, Geddes D, Simmer K. Comparing different methods of human breast milk fortification using measured v. assumed macronutrient composition to target reference growth: a randomised controlled trial. Br J Nutr. 2016 Feb 14;115(3):431-9. doi: 10.1017/S0007114515004614. Epub 2015 Dec 2.</citation>
    <PMID>26627899</PMID>
  </reference>
  <reference>
    <citation>Rochow N, Landau-Crangle E, Fusch C. Challenges in breast milk fortification for preterm infants. Curr Opin Clin Nutr Metab Care. 2015 May;18(3):276-84. doi: 10.1097/MCO.0000000000000167.</citation>
    <PMID>25807355</PMID>
  </reference>
  <results_reference>
    <citation>Macedo I, Pereira-da-Silva L, Cardoso M. Associations of Measured Protein and Energy Intakes with Growth and Adiposity in Human Milk-Fed Preterm Infants at Term Postmenstrual Age: A Cohort Study. Am J Perinatol. 2018 Jul;35(9):882-891. doi: 10.1055/s-0038-1626717. Epub 2018 Feb 2.</citation>
    <PMID>29532450</PMID>
  </results_reference>
  <results_reference>
    <citation>Henriksen C, Westerberg AC, Ronnestad A, Nakstad B, Veierod MB, Drevon CA, Iversen PO. Growth and nutrient intake among very-low-birth-weight infants fed fortified human milk during hospitalisation. Br J Nutr. 2009 Oct;102(8):1179-86. doi: 10.1017/S0007114509371755. Epub 2009 May 18.</citation>
    <PMID>19445820</PMID>
  </results_reference>
  <results_reference>
    <citation>Maas C, Wiechers C, Bernhard W, Poets CF, Franz AR. Early feeding of fortified breast milk and in-hospital-growth in very premature infants: a retrospective cohort analysis. BMC Pediatr. 2013 Nov 4;13:178. doi: 10.1186/1471-2431-13-178.</citation>
    <PMID>24180239</PMID>
  </results_reference>
  <results_reference>
    <citation>Morlacchi L, Mallardi D, Gianni ML, Roggero P, Amato O, Piemontese P, Consonni D, Mosca F. Is targeted fortification of human breast milk an optimal nutrition strategy for preterm infants? An interventional study. J Transl Med. 2016 Jul 1;14(1):195. doi: 10.1186/s12967-016-0957-y.</citation>
    <PMID>27370649</PMID>
  </results_reference>
  <results_reference>
    <citation>Polberger S. New approaches to optimizing early diets. Nestle Nutr Workshop Ser Pediatr Program. 2009;63:195-204; discussion 204-8, 259-68. doi: 10.1159/000209982.</citation>
    <PMID>19346777</PMID>
  </results_reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 18, 2020</study_first_submitted>
  <study_first_submitted_qc>May 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 22, 2020</study_first_posted>
  <last_update_submitted>June 5, 2020</last_update_submitted>
  <last_update_submitted_qc>June 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Premature Birth</mesh_term>
    <mesh_term>Obesity</mesh_term>
  </condition_browse>
  <!-- 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/NCT04400396
org study id: CHULC.CI512.2020
nct id: NCT04400396
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
It is reported that the standard method for fortification of human milk (HM) overestimates
      the energy and protein densities of HM (Macedo MHNP 2018), thus originating infant
      undernutrition (Macedo AJP 2018). The target fortification, based on analysis of HM
      composition, is considered the gold-standard method (Rochow 2015, McLeod 2016). This
      observational mixed cohort study aims to assess if very preterm infants fed HM with target
      fortification have greater growth during hospital stay and better body composition at term
      post-menstrual age (PMA), than those fed HM with standard fortification.
Study design: observational mixed cohort study, comparing growth and body composition in a
      contemporary cohort of very preterm infants fed HM with target fortification, the currently
      adopted clinical practice, with a historical cohort of very preterm infants fed HM with
      standard fortification (Macedo AJP 2018).

      Study periods: historical cohort from 1 February 2014 to 28 February 2015; contemporary
      cohort: start February 2020, estimated recruitment period of 16 months; Settings: Neonatal
      Care Unit (NICU) and Human Milk Bank at Maternidade Dr. Alfredo da Costa and Nutrition
      Laboratory at Hospital Dona Estefânia, Centro Hospitalar Universitário de Lisboa Central.

      Product to be analyzed: HM, including mother's own milk (MOM) and donor's milk (DHM). Donor
      HM is pasteurized using the Holder method (Peila 2016) which is adopted by the Human Milk
      Bank of Maternidade Dr. Alfredo da Costa (Macedo MHNP 2018).

      Demographic variables: Gestational age, sex, singleton or twin, birth weight, small-,
      appropriate- or large-for-gestational age (<3rd percentile, ≥3rd percentile and ≤97th
      percentile, >97th percentile, respectively) (Fenton 2013), severity index (SNAPPE II)
      (Richardson 2001), use of prenatal corticosteroids, diagnosis of late sepsis (Modi 2009),
      necrotizing enterocolitis (grade ≥ 3) (Bell 1971), intraperiventricular hemorrhage (grade ≥
      3) (Papile 1978), multicystic periventricular leukomalacia (de Vries 1992), and chronic lung
      disease (Becker 1984).

      Method of collection and analysis of HM: as described in a previous study (Macedo MHNP 2018),
      in order to minimize daily variability of breast milk composition, mothers are asked to save
      milk collected through 24 hours in the same container. The HM composition (MOM and DHM) are
      analyzed using the Miris human milk analyzer (Miris AB, Uppsala, Sweden), following the
      method described in a previous study (Macedo MHNP 2018). The composition is expressed in
      densities: Kcal/dL of energy and g/dl of fat, raw and true protein, carbohydrates and ashes.

      Energy and macronutrient composition of the multi-component HM fortifier and modular protein
      and fat supplements. For this purpose, an Excel program to calculate modular protein and fat
      supplements to be added to fortified HM was developed and registered (Nona R, Cardoso M,
      Portuguese Directorate of Intellectual Property Services, IGAC-DSPI, nº 480/2020, 26 February
      2020).

      Daily intakes of energy (Kcal/kg), protein (g/kg) and protein:energy ratio (P:E), based on
      administered volume of milk (ml/kg).

      Anthropometric and body composition measurements in infants: According to the previously
      described method (Macedo AJP 2018), during the hospital stay, the same observer (MMC)
      measures daily the body weight (allowing the calculation of weight gain velocity), and weekly
      the length and the head circumference. Within the first week after discharge, body
      composition will be assessed using displacement plethysmography, to evaluate fat mass (FM),
      fat free mass (FFM), percentage of FM (%FM), percentage of FFM (%FFM) and FM index (FMI), as
      described in a previous study (Macedo AJP 2018). Both FMI and %FM are used as indicators of
      adiposity.

      Estimate of sample size: The study sample size was calculated to detect a difference of 2
      g/kg/day in growth velocity with a standard deviation 2.6 (Macedo, 2018; Tremblay, 2017) for
      normally distributed variables, a significance level of 0.05, and an 80% power; thus, a
      required sample of 67 infants (n1=33; n2+20%=34) was estimated.
observational model: Cohort
time perspective: Other
measure: weight gain velocity rate
time frame: from baseline (the first day of exclusive or predominantly feeding with fortified human milk) up to 40 weeks postmenstrual age or to home discharge, whatever comes first
description: average relative daily variation of body weight
measure: length velocity rate
time frame: from baseline (the first day of exclusive or predominantly feeding with fortified human milk) up to 40 weeks postmenstrual age or to home discharge, whatever comes first
description: average relative weekly variation of body length
measure: head circumference velocity rate
time frame: from baseline (the first day of exclusive or predominantly feeding with fortified human milk) up to 40 weeks postmenstrual age or to home discharge, whatever comes first
description: average relative weekly variation of head circumference
measure: adiposity (fat mass index)
time frame: A single measurement performed up to 10 days after home discharge
description: ratio of fat mass over squared body length
measure: adiposity (fat mass percentage)
time frame: A single measurement performed up to 10 days after home discharge
description: proportion of fat mass on total body mass
arm group label: target HM fortification
description: Contemporary cohort fed HM with target fortification
arm group label: standard HM fortification
description: Historical cohort fed HM with standard fortification
intervention type: Dietary Supplement
intervention name: standard HM fortification
description: Based on the assumed energy and macronutrient composition of HM, the commercial multi-component HM fortifier was added, in order to compensate identified nutritional deficits.
arm group label: standard HM fortification
intervention type: Dietary Supplement
intervention name: target HM fortification
description: Based on the measured energy and macronutrient composition of HM, modular protein and fat supplements are added, in addition to the commercial multi-component HM fortifier, in order to correct identified specific nutritional deficits. For this purpose, an Excel program to calculate modular protein and fat supplements to be added to fortified HM was developed and registered (Nona R, Cardoso M, Portuguese Directorate of Intellectual Property Services, IGAC-DSPI, nº 480/2020, 26 February 2020)
arm group label: target HM fortification
Human milk (HM), including mother's own milk (MOM) and donor's milk (DHM).
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 1 Day
maximum age: N/A
healthy volunteers: No
last name: Luis Pereira-da-Silva, MD, PhD
role: Study Director
affiliation: Universidade Nova de Lisboa
facility: 
country: Portugal
citation: Macedo I, Pereira-da-Silva L, Cardoso M. The fortification method relying on assumed human milk composition overestimates the actual energy and macronutrient intakes in very preterm infants. Matern Health Neonatol Perinatol. 2018 Sep 17;4:22. doi: 10.1186/s40748-018-0090-4. eCollection 2018.
PMID: 30237896
citation: McLeod G, Sherriff J, Hartmann PE, Nathan E, Geddes D, Simmer K. Comparing different methods of human breast milk fortification using measured v. assumed macronutrient composition to target reference growth: a randomised controlled trial. Br J Nutr. 2016 Feb 14;115(3):431-9. doi: 10.1017/S0007114515004614. Epub 2015 Dec 2.
PMID: 26627899
citation: Rochow N, Landau-Crangle E, Fusch C. Challenges in breast milk fortification for preterm infants. Curr Opin Clin Nutr Metab Care. 2015 May;18(3):276-84. doi: 10.1097/MCO.0000000000000167.
PMID: 25807355
citation: Macedo I, Pereira-da-Silva L, Cardoso M. Associations of Measured Protein and Energy Intakes with Growth and Adiposity in Human Milk-Fed Preterm Infants at Term Postmenstrual Age: A Cohort Study. Am J Perinatol. 2018 Jul;35(9):882-891. doi: 10.1055/s-0038-1626717. Epub 2018 Feb 2.
PMID: 29532450
citation: Henriksen C, Westerberg AC, Ronnestad A, Nakstad B, Veierod MB, Drevon CA, Iversen PO. Growth and nutrient intake among very-low-birth-weight infants fed fortified human milk during hospitalisation. Br J Nutr. 2009 Oct;102(8):1179-86. doi: 10.1017/S0007114509371755. Epub 2009 May 18.
PMID: 19445820
citation: Maas C, Wiechers C, Bernhard W, Poets CF, Franz AR. Early feeding of fortified breast milk and in-hospital-growth in very premature infants: a retrospective cohort analysis. BMC Pediatr. 2013 Nov 4;13:178. doi: 10.1186/1471-2431-13-178.
PMID: 24180239
citation: Morlacchi L, Mallardi D, Gianni ML, Roggero P, Amato O, Piemontese P, Consonni D, Mosca F. Is targeted fortification of human breast milk an optimal nutrition strategy for preterm infants? An interventional study. J Transl Med. 2016 Jul 1;14(1):195. doi: 10.1186/s12967-016-0957-y.
PMID: 27370649
citation: Polberger S. New approaches to optimizing early diets. Nestle Nutr Workshop Ser Pediatr Program. 2009;63:195-204; discussion 204-8, 259-68. doi: 10.1159/000209982.
PMID: 19346777
responsible party type: Sponsor
mesh term: Premature Birth
mesh term: Obesity