<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/NCT04499430</url>
  </required_header>
  <id_info>
    <org_study_id>KA-20053</org_study_id>
    <nct_id>NCT04499430</nct_id>
  </id_info>
  <brief_title>Comparison of the Results of Premature Babies Started Complementary Feeding</brief_title>
  <acronym>COTROPBSCF</acronym>
  <official_title>Comparison of the Results of Premature Babies Started Complementary Feeding in Adjusted or Chronologically in Their Sixth Month</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hacettepe University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hacettepe University</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>
      Neurological-developmental evaluations and developmental outcomes-diagnoses of premature&#xD;
      babies are evaluated according to corrected postnatal age. Based on the limited evidence&#xD;
      available, it can be concluded that complementary feeding may be an appropriate age for most&#xD;
      premature babies who have reached at least the third month, generally corrected. However, for&#xD;
      premature babies born at different gestational weeks, these periods have a relatively&#xD;
      different meaning. A more accurate timeframe can be found in terms of complementary nutrition&#xD;
      by evaluating chronological age and motor development together. More prospective&#xD;
      observational studies are needed in this regard in premature babies. In the literature, there&#xD;
      are not enough studies on the transition time to the most appropriate complementary diet for&#xD;
      premature babies. The investigators planned to do this prospective observational study. In&#xD;
      this study, patient groups will be randomly selected after appropriate matching. Premature&#xD;
      babies participating in the study will be handled in three main groups (six subgroups in&#xD;
      total). The data will be added to the case report forms. In addition to routine follow-ups,&#xD;
      families will be called on the phone monthly, information about their babies' nutrition will&#xD;
      be asked, whether there is a problem, questions of families will be answered, and information&#xD;
      about complementary nutrition will be provided. At the end of the study, all data will be&#xD;
      collected and entered into the SPSS database, which will be created.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The transition to complementary feeding in premature babies (37 weeks and over) is&#xD;
      recommended by both the World Health Organization (WHO) and the European Gastroenterology,&#xD;
      Hepatology and Nutrition Association (ESPHGAN) for 4-6 months. However, a full consensus on&#xD;
      the transition time to complementary feeding has not been achieved for premature babies. It&#xD;
      is controversial whether premature babies (born 37th week of gestation) are corrected for&#xD;
      complementary feeding in the sixth month or chronological sixth month. According to the&#xD;
      known, there are no clinical studies investigating this topic in the literature.&#xD;
&#xD;
      Neurological-developmental evaluations and developmental outcomes-diagnoses of premature&#xD;
      babies are evaluated according to corrected postnatal age. Based on the limited evidence&#xD;
      available, it can be concluded that complementary feeding may be an appropriate age for most&#xD;
      premature babies who have reached at least the third month, generally corrected. However, for&#xD;
      premature babies born at different gestational weeks, these periods have a relatively&#xD;
      different meaning. A more accurate timeframe can be found in terms of complementary nutrition&#xD;
      by evaluating chronological age and motor development together. More prospective&#xD;
      observational studies are needed in this regard in premature babies. In the literature, there&#xD;
      are not enough studies on the transition time to the most appropriate complementary diet for&#xD;
      premature babies. The investigators planned to do this prospective observational study.&#xD;
&#xD;
      In this study, patient groups will be randomly selected after appropriate matching. Premature&#xD;
      babies participating in the study will be handled in three main groups (six subgroups in&#xD;
      total).&#xD;
&#xD;
      Before the transition to complementary nutrition of the groups included in the study, breast&#xD;
      milk and / or formula food, nutritional supplement (such as breast milk enhancer, protein&#xD;
      supplement) intake will be recorded. The same polyvitamin preparation will be used for all&#xD;
      premature babies. In accordance with the recommendation of the World Health Organization, 2&#xD;
      mg / kg / day standard oral iron prophylaxis will be started to all premature babies starting&#xD;
      from the second chronological month. Immunization will be done in accordance with the&#xD;
      national vaccination program.&#xD;
&#xD;
      The data will be added to the case report forms. In addition to routine follow-ups, families&#xD;
      will be called on the phone monthly, information about their babies' nutrition will be asked,&#xD;
      whether there is a problem, questions of families will be answered, and information about&#xD;
      complementary nutrition will be provided. At the end of the study, all data will be collected&#xD;
      and entered into the SPSS database, which will be created.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">June 8, 2020</start_date>
  <completion_date type="Anticipated">June 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2022</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>24 Months</target_duration>
  <primary_outcome>
    <measure>the transition time to the most appropriate complementary diet for premature babies</measure>
    <time_frame>24 months</time_frame>
    <description>. In the literature, there are not enough studies on the transition time to the most appropriate complementary diet for premature babies. We planned to do this prospective observational study.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Reaching the targeted number of patients</measure>
    <time_frame>24 months</time_frame>
    <description>In this time we aim to reach the targeted number of patients</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Premature Birth</condition>
  <condition>Feeding Behavior</condition>
  <arm_group>
    <arm_group_label>1</arm_group_label>
    <description>Group 1: 29 weeks and six days of gestation and earlier&#xD;
Group 1a: complementary feeding began chronologically in the sixth month&#xD;
Group 1b: Complementary feeding corrected at sixth month</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2</arm_group_label>
    <description>Group 2: Those whose gestational age is between 30 weeks and 33 weeks and sixth days&#xD;
Group 2a: complementary feeding began chronologically in the sixth month&#xD;
Group 2b: complementary feeding started in the sixth month, corrected</description>
  </arm_group>
  <arm_group>
    <arm_group_label>3</arm_group_label>
    <description>Group 3: Those whose gestational age is between 34 weeks and 37 weeks and sixth day&#xD;
Group 3a: complementary feeding began chronologically in the sixth month&#xD;
Group 3b: complementary feeding started in the sixth month, corrected</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Group 1: 29 weeks and six days of gestation and earlier Group 2: Those whose gestational&#xD;
        age is between 30 weeks and 33 weeks and sixth days Group 3: Those whose gestational age is&#xD;
        between 34 weeks and 37 weeks and sixth day&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male / female babies who were born before the mother at the Hacettepe University&#xD;
             Children's Hospital Neonatal Intensive Care Unit and / or Hacettepe University Adult&#xD;
             Hospital Maternity and Birth Service and were born earlier than 37 weeks.&#xD;
&#xD;
          -  Babies who are at the Hacettepe University Children's Hospital Neonatal Intensive Care&#xD;
             Unit and / or Hacettepe University Adult Hospital Maternity and Maternity Service,&#xD;
             were born earlier than 37 weeks and continue to be followed regularly in the neonatal&#xD;
             outpatient clinic.&#xD;
&#xD;
          -  Babies whose informed consent was obtained for their participation by the family.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Babies with SGA (birth weight below 10th percentile according to gestational week) by&#xD;
             birth weight&#xD;
&#xD;
          -  Babies with chromosomal anomalies&#xD;
&#xD;
          -  Babies diagnosed with hypoxic ischemic encephalopathy&#xD;
&#xD;
          -  Babies who have had major surgical operations (gastrointestinal anomaly, severe&#xD;
             necrotizing enterocolitis requiring surgery, major gastrointestinal system anomaly,&#xD;
             major congenital heart anomaly, diaphragmatic hernia)&#xD;
&#xD;
          -  Babies with exitus in the neonatal period&#xD;
&#xD;
          -  Babies who do not continue regular polyclinic follow-up after discharge&#xD;
&#xD;
          -  Babies of families who do not comply with the study protocol&#xD;
&#xD;
          -  Babies with missing study data&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>24 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hacettepe University</name>
      <address>
        <city>Ankara</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <link>
    <url>https://pubmed.ncbi.nlm.nih.gov/22555185/</url>
    <description>complementary feeding</description>
  </link>
  <link>
    <url>https://pubmed.ncbi.nlm.nih.gov/29502384/</url>
    <description>weaning and complementary feeding in premature babies</description>
  </link>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>July 31, 2020</study_first_submitted>
  <study_first_submitted_qc>July 31, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>August 5, 2020</last_update_submitted>
  <last_update_submitted_qc>August 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hacettepe University</investigator_affiliation>
    <investigator_full_name>H. Tolga Çelik</investigator_full_name>
    <investigator_title>associate professor</investigator_title>
  </responsible_party>
  <keyword>complementary feeding</keyword>
  <keyword>prematurity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Premature Birth</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 2, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/30/NCT04499430/Prot_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT04499430
org study id: KA-20053
nct id: NCT04499430
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Neurological-developmental evaluations and developmental outcomes-diagnoses of premature
      babies are evaluated according to corrected postnatal age. Based on the limited evidence
      available, it can be concluded that complementary feeding may be an appropriate age for most
      premature babies who have reached at least the third month, generally corrected. However, for
      premature babies born at different gestational weeks, these periods have a relatively
      different meaning. A more accurate timeframe can be found in terms of complementary nutrition
      by evaluating chronological age and motor development together. More prospective
      observational studies are needed in this regard in premature babies. In the literature, there
      are not enough studies on the transition time to the most appropriate complementary diet for
      premature babies. The investigators planned to do this prospective observational study. In
      this study, patient groups will be randomly selected after appropriate matching. Premature
      babies participating in the study will be handled in three main groups (six subgroups in
      total). The data will be added to the case report forms. In addition to routine follow-ups,
      families will be called on the phone monthly, information about their babies' nutrition will
      be asked, whether there is a problem, questions of families will be answered, and information
      about complementary nutrition will be provided. At the end of the study, all data will be
      collected and entered into the SPSS database, which will be created.
The transition to complementary feeding in premature babies (37 weeks and over) is
      recommended by both the World Health Organization (WHO) and the European Gastroenterology,
      Hepatology and Nutrition Association (ESPHGAN) for 4-6 months. However, a full consensus on
      the transition time to complementary feeding has not been achieved for premature babies. It
      is controversial whether premature babies (born 37th week of gestation) are corrected for
      complementary feeding in the sixth month or chronological sixth month. According to the
      known, there are no clinical studies investigating this topic in the literature.

      Neurological-developmental evaluations and developmental outcomes-diagnoses of premature
      babies are evaluated according to corrected postnatal age. Based on the limited evidence
      available, it can be concluded that complementary feeding may be an appropriate age for most
      premature babies who have reached at least the third month, generally corrected. However, for
      premature babies born at different gestational weeks, these periods have a relatively
      different meaning. A more accurate timeframe can be found in terms of complementary nutrition
      by evaluating chronological age and motor development together. More prospective
      observational studies are needed in this regard in premature babies. In the literature, there
      are not enough studies on the transition time to the most appropriate complementary diet for
      premature babies. The investigators planned to do this prospective observational study.

      In this study, patient groups will be randomly selected after appropriate matching. Premature
      babies participating in the study will be handled in three main groups (six subgroups in
      total).

      Before the transition to complementary nutrition of the groups included in the study, breast
      milk and / or formula food, nutritional supplement (such as breast milk enhancer, protein
      supplement) intake will be recorded. The same polyvitamin preparation will be used for all
      premature babies. In accordance with the recommendation of the World Health Organization, 2
      mg / kg / day standard oral iron prophylaxis will be started to all premature babies starting
      from the second chronological month. Immunization will be done in accordance with the
      national vaccination program.

      The data will be added to the case report forms. In addition to routine follow-ups, families
      will be called on the phone monthly, information about their babies' nutrition will be asked,
      whether there is a problem, questions of families will be answered, and information about
      complementary nutrition will be provided. At the end of the study, all data will be collected
      and entered into the SPSS database, which will be created.
observational model: Cohort
time perspective: Prospective
measure: the transition time to the most appropriate complementary diet for premature babies
time frame: 24 months
description: . In the literature, there are not enough studies on the transition time to the most appropriate complementary diet for premature babies. We planned to do this prospective observational study.
measure: Reaching the targeted number of patients
time frame: 24 months
description: In this time we aim to reach the targeted number of patients
arm group label: 1
description: Group 1: 29 weeks and six days of gestation and earlier
Group 1a: complementary feeding began chronologically in the sixth month
Group 1b: Complementary feeding corrected at sixth month
arm group label: 2
description: Group 2: Those whose gestational age is between 30 weeks and 33 weeks and sixth days
Group 2a: complementary feeding began chronologically in the sixth month
Group 2b: complementary feeding started in the sixth month, corrected
arm group label: 3
description: Group 3: Those whose gestational age is between 34 weeks and 37 weeks and sixth day
Group 3a: complementary feeding began chronologically in the sixth month
Group 3b: complementary feeding started in the sixth month, corrected
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 6 Months
maximum age: 24 Months
healthy volunteers: No
facility: 
country: Turkey
url: https://pubmed.ncbi.nlm.nih.gov/22555185/
description: complementary feeding
url: https://pubmed.ncbi.nlm.nih.gov/29502384/
description: weaning and complementary feeding in premature babies
responsible party type: Principal Investigator
investigator affiliation: Hacettepe University
investigator full name: H. Tolga Çelik
investigator title: associate professor
mesh term: Premature Birth
provided document: 