xml: <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/NCT05989009</url>
    </required_header>
    <id_info>
      <org_study_id>1669</org_study_id>
      <nct_id>NCT05989009</nct_id>
    </id_info>
    <brief_title>Analysis of Lipids in Human Milk at Different Gestational Ages</brief_title>
    <official_title>Essential Long-chain Polyunsaturated Fatty Acids Quantitation in Breast Milk Samples at Different Gestational Ages</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ospedale Buon Consiglio Fatebenefratelli</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University of Salerno</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Ospedale Buon Consiglio Fatebenefratelli</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>
        Various studies have shown that the milk of a preterm infant differs from that of a term&#xD;
        infant in the composition of micronutrients, vitamins, macronutrients, carbohydrates and&#xD;
        proteins. The study of lipidomic is of particular interest because the role of fatty acids is&#xD;
        known both as essential constituents of cell membranes and as molecules actively involved in&#xD;
        energy metabolism. The study of human milk would offer the advantage of offering the best&#xD;
        type of nutrition for the newborn at each specific period of life, in the event of a lack of&#xD;
        mother's milk.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Mother's milk is the best food for the newborn as it is the only one capable of providing&#xD;
        species-specific nutrition, guaranteeing everything necessary for the growth and maturation&#xD;
        of a child. Mother's milk has the property of satisfying metabolic needs by changes in the&#xD;
        composition of nutrients, which are different at each stage of life. Various studies have&#xD;
        shown that the milk of a preterm infant differs from that of a term infant in the composition&#xD;
        of micronutrients, such as vitamins, macronutrients, carbohydrates and proteins. The&#xD;
        metabolomic study of human milk would offer the advantage of offering the best type of&#xD;
        nutrition for the newborn at each specific period of life, in the event of a lack of mother's&#xD;
        milk. This is particularly important in a Neonatal Intensive Care Unit, where it is essential&#xD;
        to ensure timely adequate enteral nutrition. This is possible if a bank of donated human milk&#xD;
        is available. The study of lipidomics is of particular interest, as the role of fatty acids&#xD;
        is known both as essential constituents of cell membranes and as molecules actively involved&#xD;
        in energy metabolism. Therefore, the benefit deriving from an adequate dietary intake in a&#xD;
        constantly evolving organism such as that of a newborn is extremely important.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">March 1, 2022</start_date>
    <completion_date type="Anticipated">October 1, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 1, 2023</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>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Quantification of essential long-chain polyunsaturated fatty acids in human milk</measure>
      <time_frame>7 days after delivery</time_frame>
      <description>To assess the concentrations of α-Linoleic acid (µg/mL) in human milk</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Quantification of essential long-chain polyunsaturated fatty acids in human milk</measure>
      <time_frame>7 days after delivery</time_frame>
      <description>To assess the concentrations of Eicosapentaenoic acid (µg/mL) in human milk</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Quantification of essential long-chain polyunsaturated fatty acids in human milk</measure>
      <time_frame>7 days after delivery</time_frame>
      <description>To assess the concentrations of Docosahexaenoic acid (µg/mL) in human milk</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Quantification of essential long-chain polyunsaturated fatty acids in human milk</measure>
      <time_frame>7 days after delivery</time_frame>
      <description>To assess the concentrations of Arachidonic acid (µg/mL) in human milk</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Quantification of essential long-chain polyunsaturated fatty acids in human milk</measure>
      <time_frame>7 days after delivery</time_frame>
      <description>To assess the concentrations of Linoleic acid (µg/mL) in human milk</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Quantification of essential long-chain polyunsaturated fatty acids in human milk</measure>
      <time_frame>1 month after delivery</time_frame>
      <description>To assess the concentrations of α-Linoleic acid (µg/mL) in human milk</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quantification of essential long-chain polyunsaturated fatty acids in human milk</measure>
      <time_frame>1 month after delivery</time_frame>
      <description>To assess the concentrations of Eicosapentaenoic acid (µg/mL) in human milk</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quantification of essential long-chain polyunsaturated fatty acids in human milk</measure>
      <time_frame>1 month after delivery</time_frame>
      <description>To assess the concentrations of Docosahexaenoic acid (µg/mL) in human milk</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quantification of essential long-chain polyunsaturated fatty acids in human milk</measure>
      <time_frame>1 month after delivery</time_frame>
      <description>To assess the concentrations of Arachidonic acid (µg/mL) in human milk</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quantification of essential long-chain polyunsaturated fatty acids in human milk</measure>
      <time_frame>1 month after delivery</time_frame>
      <description>To assess the concentrations of Linoleic acid (µg/mL) in human milk</description>
    </secondary_outcome>
    <number_of_groups>3</number_of_groups>
    <enrollment type="Anticipated">66</enrollment>
    <condition>Breast Milk Collection</condition>
    <arm_group>
      <arm_group_label>Women &lt; 32 weeks of gestational age</arm_group_label>
      <description>Women that delivered before 32 weeks of gestational age</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Women between 32 and 36,6 weeks of gestational age</arm_group_label>
      <description>Women that delivered between 32 and 36,6 weeks of gestational age</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Women &gt; 37 weeks of gestational age</arm_group_label>
      <description>Women that delivered after 37 weeks of gestational age</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Breastfeeding</intervention_name>
      <description>Mothers will breastfeed their newborns</description>
      <arm_group_label>Women &lt; 32 weeks of gestational age</arm_group_label>
      <arm_group_label>Women &gt; 37 weeks of gestational age</arm_group_label>
      <arm_group_label>Women between 32 and 36,6 weeks of gestational age</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          They were enrolled mothers that delivered at Buon Consiglio Fatebenefratelli Hospital,&#xD;
          Napoli&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Mothers who have given birth in hospital at any gestational age&#xD;
  &#xD;
            -  Written informed consent&#xD;
  &#xD;
            -  BMI 18.50-24.99 Kg/m2&#xD;
  &#xD;
            -  Varied and balanced maternal diet without restrictions&#xD;
  &#xD;
            -  Weight gain during pregnancy up to 12kg&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Food intolerance&#xD;
  &#xD;
            -  Celiac disease&#xD;
  &#xD;
            -  Vegan or vegetarian diet&#xD;
  &#xD;
            -  Diet with the exclusion of milk and derivatives&#xD;
  &#xD;
            -  Diagnosis of metabolic diseases&#xD;
  &#xD;
            -  Taking medicines during pregnancy&#xD;
  &#xD;
            -  Withdrawal of informed consent&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Giuseppe De Bernardo, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Ospedale Buon Consiglio Fatebenefratelli</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Giuseppe De Bernardo, MD</last_name>
      <phone>3357441303</phone>
      <email>pinodebtin@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Department of Pharmacy, University of Salerno</name>
        <address>
          <city>Salerno</city>
          <state>Naples</state>
          <zip>84084</zip>
          <country>Italy</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Pietro Campiglia, Prof</last_name>
        <email>pcampiglia@unisa.it</email>
      </contact>
      <investigator>
        <last_name>Pietro Campiglia, Prof</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Giacomo Pepe, Prof</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Manuela Giovanna Basilicata, Dr</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Emanuela Salviati, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Department of Woman and Child, Buon Consiglio Fatebenefratelli Hospital</name>
        <address>
          <city>Napoli</city>
          <zip>80123</zip>
          <country>Italy</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Giuseppe De Bernardo</last_name>
        <phone>3357441303</phone>
        <email>pinodebtin@gmail.com</email>
      </contact>
      <investigator>
        <last_name>Giuseppe De Bernardo, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Giuseppina Leone, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Maurizio Giordano, Dr</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 3, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 13, 2023</last_update_submitted>
    <last_update_submitted_qc>August 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Ospedale Buon Consiglio Fatebenefratelli</investigator_affiliation>
      <investigator_full_name>Giuseppe De Bernardo</investigator_full_name>
      <investigator_title>Head of Department of Woman and Child</investigator_title>
    </responsible_party>
    <keyword>newborn</keyword>
    <keyword>breast milk</keyword>
    <keyword>fatty acid</keyword>
    <keyword>gestational age</keyword>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05989009
  org study id: 1669
  nct id: NCT05989009
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Various studies have shown that the milk of a preterm infant differs from that of a term
        infant in the composition of micronutrients, vitamins, macronutrients, carbohydrates and
        proteins. The study of lipidomic is of particular interest because the role of fatty acids is
        known both as essential constituents of cell membranes and as molecules actively involved in
        energy metabolism. The study of human milk would offer the advantage of offering the best
        type of nutrition for the newborn at each specific period of life, in the event of a lack of
        mother's milk.
  Mother's milk is the best food for the newborn as it is the only one capable of providing
        species-specific nutrition, guaranteeing everything necessary for the growth and maturation
        of a child. Mother's milk has the property of satisfying metabolic needs by changes in the
        composition of nutrients, which are different at each stage of life. Various studies have
        shown that the milk of a preterm infant differs from that of a term infant in the composition
        of micronutrients, such as vitamins, macronutrients, carbohydrates and proteins. The
        metabolomic study of human milk would offer the advantage of offering the best type of
        nutrition for the newborn at each specific period of life, in the event of a lack of mother's
        milk. This is particularly important in a Neonatal Intensive Care Unit, where it is essential
        to ensure timely adequate enteral nutrition. This is possible if a bank of donated human milk
        is available. The study of lipidomics is of particular interest, as the role of fatty acids
        is known both as essential constituents of cell membranes and as molecules actively involved
        in energy metabolism. Therefore, the benefit deriving from an adequate dietary intake in a
        constantly evolving organism such as that of a newborn is extremely important.
  observational model: Cohort
  time perspective: Prospective
  measure: Quantification of essential long-chain polyunsaturated fatty acids in human milk
  time frame: 7 days after delivery
  description: To assess the concentrations of α-Linoleic acid (µg/mL) in human milk
  measure: Quantification of essential long-chain polyunsaturated fatty acids in human milk
  time frame: 7 days after delivery
  description: To assess the concentrations of Eicosapentaenoic acid (µg/mL) in human milk
  measure: Quantification of essential long-chain polyunsaturated fatty acids in human milk
  time frame: 7 days after delivery
  description: To assess the concentrations of Docosahexaenoic acid (µg/mL) in human milk
  measure: Quantification of essential long-chain polyunsaturated fatty acids in human milk
  time frame: 7 days after delivery
  description: To assess the concentrations of Arachidonic acid (µg/mL) in human milk
  measure: Quantification of essential long-chain polyunsaturated fatty acids in human milk
  time frame: 7 days after delivery
  description: To assess the concentrations of Linoleic acid (µg/mL) in human milk
  measure: Quantification of essential long-chain polyunsaturated fatty acids in human milk
  time frame: 1 month after delivery
  description: To assess the concentrations of α-Linoleic acid (µg/mL) in human milk
  measure: Quantification of essential long-chain polyunsaturated fatty acids in human milk
  time frame: 1 month after delivery
  description: To assess the concentrations of Eicosapentaenoic acid (µg/mL) in human milk
  measure: Quantification of essential long-chain polyunsaturated fatty acids in human milk
  time frame: 1 month after delivery
  description: To assess the concentrations of Docosahexaenoic acid (µg/mL) in human milk
  measure: Quantification of essential long-chain polyunsaturated fatty acids in human milk
  time frame: 1 month after delivery
  description: To assess the concentrations of Arachidonic acid (µg/mL) in human milk
  measure: Quantification of essential long-chain polyunsaturated fatty acids in human milk
  time frame: 1 month after delivery
  description: To assess the concentrations of Linoleic acid (µg/mL) in human milk
  arm group label: Women < 32 weeks of gestational age
  description: Women that delivered before 32 weeks of gestational age
  arm group label: Women between 32 and 36,6 weeks of gestational age
  description: Women that delivered between 32 and 36,6 weeks of gestational age
  arm group label: Women > 37 weeks of gestational age
  description: Women that delivered after 37 weeks of gestational age
  intervention type: Other
  intervention name: Breastfeeding
  description: Mothers will breastfeed their newborns
  arm group label: Women < 32 weeks of gestational age
  arm group label: Women > 37 weeks of gestational age
  arm group label: Women between 32 and 36,6 weeks of gestational age
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Giuseppe De Bernardo, MD
  role: Principal Investigator
  affiliation: Ospedale Buon Consiglio Fatebenefratelli
  last name: Giuseppe De Bernardo, MD
  phone: 3357441303
  email: pinodebtin@gmail.com
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  investigator: 
  investigator: 
  country: Italy
  responsible party type: Principal Investigator
  investigator affiliation: Ospedale Buon Consiglio Fatebenefratelli
  investigator full name: Giuseppe De Bernardo
  investigator title: Head of Department of Woman and Child