<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/NCT04431128</url>
  </required_header>
  <id_info>
    <org_study_id>Clalit HS</org_study_id>
    <nct_id>NCT04431128</nct_id>
  </id_info>
  <brief_title>Adenoid Hypertrophy, Respiratory Complications and Correlation With Infant Feeding Position</brief_title>
  <official_title>Adenoid Hypertrophy, Etiology, Clinical Manifestations and Related Morbidity, Correlation With Infant Feeding Position</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hadassah Medical Organization</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Clalit Health Services</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hadassah Medical Organization</source>
  <brief_summary>
    <textblock>
      500 children aged 0-5 years followed since birth by Principal Investigator (PI)since&#xD;
      January1, 2003 till December 31, 2018 and diagnosed with adenoid hypertrophy (AH) (study&#xD;
      group) and 500 children aged 0-5 years followed by principal investigator during the same&#xD;
      years and diagnosed as urinary tract infection (UTI), gastroenteritis (GE), diarrhea,&#xD;
      vomiting but without AH (control group) were compared. Morbidity and treatment will be&#xD;
      compared and correlated with gastro-esophageal reflux (GER), allergy and infant feeding&#xD;
      position during the first few years of life in the two groups.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The 2 groups are children aged 0-5 years and treated by PI and followed since birth during&#xD;
      years 2003-2018. Study group consists of children diagnosed at least 2 times as AH and&#xD;
      control group as similar children with UTI, GE, vomiting or diarrhea. Respiratory problems&#xD;
      (pneumonia, bronchopneumonia, bronchitis), ear problems (otitis media OM, serous OM),&#xD;
      antibiotic treatment, use of bronchodilators, inhaled corticosteroid (ICS), chest X-rays,&#xD;
      anomalous laboratory results, emergency room visits and hospitalization rates will be&#xD;
      compared in the two groups, together with details concerning feeding position during the&#xD;
      first years of life. Correlation between morbidity, degree of nasopharyngeal obstruction,&#xD;
      allergy, GER and supine feeding position, will be evaluated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2003</start_date>
  <completion_date type="Actual">June 6, 2020</completion_date>
  <primary_completion_date type="Actual">December 31, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Respiratory complications</measure>
    <time_frame>3 years</time_frame>
    <description>Number of participants with Pneumonia, bronchitis</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Ear complications</measure>
    <time_frame>3 years</time_frame>
    <description>Number of participants with otitis media, serous otitis media</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Correlations between morbidity, degree of adenoid hypertrophy and feeding position</measure>
    <time_frame>5 years</time_frame>
    <description>Correlation between respiratory morbidity, ear morbidity, laboratory and chest &amp; nasopharynx X-rays with feeding position in first year of life&#xD;
Correlation between respiratory and ENT morbidity with degree of adenoid obstruction, allergy, GER and infant feeding position during the first 2 years of life.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">500</enrollment>
  <condition>Adenoid Hypertrophy</condition>
  <arm_group>
    <arm_group_label>study group</arm_group_label>
    <description>Adenoid hypertrophy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <description>UTI, GE, vomiting, diarrhea</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>infant feeding position</intervention_name>
    <description>correlation with allergy, GER or feeding position</description>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>study group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Young infants followed since birth or from the first half of the first year of life,&#xD;
        followed at least for 5 years by PI, study group (till 500 children) with the diagnosis of&#xD;
        AH, control group (till 500 children) diagnosed as UTI, GE, vomiting or diarrhea and&#xD;
        without AH.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria: Study group: Young children with diagnosis of adenoid hypertrophy&#xD;
        followed by PI Control group: young children with diagnosis of UTI, GE, vomiting or&#xD;
        diarrhea followed by PI&#xD;
&#xD;
        Exclusion Criteria: Children with cystic fibrosis, primary dyskinesia, immune deficiency,&#xD;
        congenital anatomical malformations of nasal or airway passages.&#xD;
&#xD;
        Children older than 6 months of age when starting to be followed by PI.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Month</minimum_age>
    <maximum_age>5 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hadassah Medical Organization, Jerusalem, Israel</name>
      <address>
        <city>Jerusalem</city>
        <zip>P.P.Box 12000</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <results_reference>
    <citation>Tully SB, Bar-Haim Y, Bradley RL. Abnormal tympanography after supine bottle feeding. J Pediatr. 1995 Jun;126(6):S105-11. doi: 10.1016/s0022-3476(95)90249-x.</citation>
    <PMID>7776069</PMID>
  </results_reference>
  <results_reference>
    <citation>Konno A, Hoshino T, Togawa K. Influence of upper airway obstruction by enlarged tonsils and adenoids upon recurrent infection of the lower airway in childhood. Laryngoscope. 1980 Oct;90(10 Pt 1):1709-16.</citation>
    <PMID>7421381</PMID>
  </results_reference>
  <results_reference>
    <citation>Avital A, Donchin M, Springer C, Cohen S, Danino E. Feeding young infants with their head in upright position reduces respiratory and ear morbidity. Sci Rep. 2018 Apr 26;8(1):6588. doi: 10.1038/s41598-018-24636-0.</citation>
    <PMID>29700412</PMID>
  </results_reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 7, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>June 11, 2020</last_update_submitted>
  <last_update_submitted_qc>June 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hadassah Medical Organization</investigator_affiliation>
    <investigator_full_name>Avital Avraham</investigator_full_name>
    <investigator_title>Prof.</investigator_title>
  </responsible_party>
  <keyword>Adenoid hypertrophy</keyword>
  <keyword>Allergy</keyword>
  <keyword>Infant Feeding Position</keyword>
  <keyword>GER</keyword>
  <keyword>Pneumonia</keyword>
  <keyword>Bronchitis</keyword>
  <keyword>Otitis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertrophy</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04431128
org study id: Clalit HS
nct id: NCT04431128
lead sponsor: 
collaborator: 
500 children aged 0-5 years followed since birth by Principal Investigator (PI)since
      January1, 2003 till December 31, 2018 and diagnosed with adenoid hypertrophy (AH) (study
      group) and 500 children aged 0-5 years followed by principal investigator during the same
      years and diagnosed as urinary tract infection (UTI), gastroenteritis (GE), diarrhea,
      vomiting but without AH (control group) were compared. Morbidity and treatment will be
      compared and correlated with gastro-esophageal reflux (GER), allergy and infant feeding
      position during the first few years of life in the two groups.
The 2 groups are children aged 0-5 years and treated by PI and followed since birth during
      years 2003-2018. Study group consists of children diagnosed at least 2 times as AH and
      control group as similar children with UTI, GE, vomiting or diarrhea. Respiratory problems
      (pneumonia, bronchopneumonia, bronchitis), ear problems (otitis media OM, serous OM),
      antibiotic treatment, use of bronchodilators, inhaled corticosteroid (ICS), chest X-rays,
      anomalous laboratory results, emergency room visits and hospitalization rates will be
      compared in the two groups, together with details concerning feeding position during the
      first years of life. Correlation between morbidity, degree of nasopharyngeal obstruction,
      allergy, GER and supine feeding position, will be evaluated.
observational model: Case-Control
time perspective: Retrospective
measure: Respiratory complications
time frame: 3 years
description: Number of participants with Pneumonia, bronchitis
measure: Ear complications
time frame: 3 years
description: Number of participants with otitis media, serous otitis media
measure: Correlations between morbidity, degree of adenoid hypertrophy and feeding position
time frame: 5 years
description: Correlation between respiratory morbidity, ear morbidity, laboratory and chest & nasopharynx X-rays with feeding position in first year of life
Correlation between respiratory and ENT morbidity with degree of adenoid obstruction, allergy, GER and infant feeding position during the first 2 years of life.
arm group label: study group
description: Adenoid hypertrophy
arm group label: Control group
description: UTI, GE, vomiting, diarrhea
intervention type: Behavioral
intervention name: infant feeding position
description: correlation with allergy, GER or feeding position
arm group label: Control group
arm group label: study group
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 1 Month
maximum age: 5 Years
healthy volunteers: No
facility: 
country: Israel
citation: Tully SB, Bar-Haim Y, Bradley RL. Abnormal tympanography after supine bottle feeding. J Pediatr. 1995 Jun;126(6):S105-11. doi: 10.1016/s0022-3476(95)90249-x.
PMID: 7776069
citation: Konno A, Hoshino T, Togawa K. Influence of upper airway obstruction by enlarged tonsils and adenoids upon recurrent infection of the lower airway in childhood. Laryngoscope. 1980 Oct;90(10 Pt 1):1709-16.
PMID: 7421381
citation: Avital A, Donchin M, Springer C, Cohen S, Danino E. Feeding young infants with their head in upright position reduces respiratory and ear morbidity. Sci Rep. 2018 Apr 26;8(1):6588. doi: 10.1038/s41598-018-24636-0.
PMID: 29700412
responsible party type: Principal Investigator
investigator affiliation: Hadassah Medical Organization
investigator full name: Avital Avraham
investigator title: Prof.
mesh term: Hypertrophy
sharing ipd: No