<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/NCT03247946</url>
  </required_header>
  <id_info>
    <org_study_id>0349-10-HMO</org_study_id>
    <nct_id>NCT03247946</nct_id>
  </id_info>
  <brief_title>The Influence of Upright Feeding Position on Pulmonary and Ear Morbidity</brief_title>
  <official_title>The Influence of Upright Feeding Position on Pulmonary and Ear Morbidity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hadassah Medical Organization</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hadassah Medical Organization</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Does upright feeding position of 3 month old infants reduce respiratory and ear morbidity&#xD;
      during the following year?&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators examined the influence of teaching mothers to feed infants with their head&#xD;
      in an upright position and evaluated the infant ear and respiratory morbidity during a&#xD;
      one-year follow-up. Mothers of 88 infants born during 2011 were instructed by trained nurses&#xD;
      at Maternal-Child-Health clinics to feed their infants with their head in upright position&#xD;
      (intervention group). The control group consisted of 75 mothers of infants of similar&#xD;
      socioeconomic background who fed their infant regularly without any instructions and were&#xD;
      followed at another Maternal-Child-Health clinic. Feeding position was evaluated at the&#xD;
      beginning and the end of the study, and morbidity data of both groups were evaluated at every&#xD;
      3-month follow-up meeting. The study was part of the PhD thesis of Efrat Danino, Head Nurse&#xD;
      of Pediatric Department at Hadassah Medical Organization.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 13, 2010</start_date>
  <completion_date type="Actual">August 19, 2012</completion_date>
  <primary_completion_date type="Actual">August 19, 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>3 month old infants were recruited from 2 Mother-Child-Health clinics and followed for 12 months. Mothers from intervention group were instructed to feed their babies (88 infants) with their head in upright position. Mothers from control group (75 infants) fed their infant regularly without any instructions . Respiratory and ear morbidity were evaluated during the following 12 month period.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Infant morbidity</measure>
    <time_frame>every 12 weeks visit to Mother Child Health clinic until end of 1 year follow up</time_frame>
    <description>respiratory (cough, wheezing, physician diagnosed bronchitis or pneumonia), ear (OM, SOM), prolonged fever, use of antibiotics and inhalations.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Feeding position angle</measure>
    <time_frame>at beginning and end of study (1 year follow up)</time_frame>
    <description>description of feeding position angle</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">163</enrollment>
  <condition>Feeding and Eating Disorders</condition>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>intervention: upright head position</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>no feeding position instructions</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>upright head position</intervention_name>
    <description>Bottle feeding of infants with their head in upward and not supine head position</description>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  healthy 3 month old infants, bottle fed at least once a day, parent agreeing to&#xD;
             participate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prematurity, need of supplemental oxygen, broncho-pulmonary dysplasia, cystic&#xD;
             fibrosis, familial dysautonomia, cleft lip or cleft palate, any ear-throat-lung or&#xD;
             airway congenital anomaly, congenital heart disease, any other chronic disease of&#xD;
             childhood or malignancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Months</minimum_age>
    <maximum_age>4 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</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>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 3, 2017</study_first_submitted>
  <study_first_submitted_qc>August 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 14, 2017</study_first_posted>
  <last_update_submitted>August 12, 2017</last_update_submitted>
  <last_update_submitted_qc>August 12, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 16, 2017</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>Principal investigator, Associate Professor, Institute of Pulmonology, email: avital@hadassah.org.il</investigator_title>
  </responsible_party>
  <keyword>infant</keyword>
  <keyword>feeding position</keyword>
  <keyword>respiratory</keyword>
  <keyword>ear</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Feeding and Eating Disorders</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/NCT03247946
org study id: 0349-10-HMO
nct id: NCT03247946
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Does upright feeding position of 3 month old infants reduce respiratory and ear morbidity
      during the following year?
The investigators examined the influence of teaching mothers to feed infants with their head
      in an upright position and evaluated the infant ear and respiratory morbidity during a
      one-year follow-up. Mothers of 88 infants born during 2011 were instructed by trained nurses
      at Maternal-Child-Health clinics to feed their infants with their head in upright position
      (intervention group). The control group consisted of 75 mothers of infants of similar
      socioeconomic background who fed their infant regularly without any instructions and were
      followed at another Maternal-Child-Health clinic. Feeding position was evaluated at the
      beginning and the end of the study, and morbidity data of both groups were evaluated at every
      3-month follow-up meeting. The study was part of the PhD thesis of Efrat Danino, Head Nurse
      of Pediatric Department at Hadassah Medical Organization.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: 3 month old infants were recruited from 2 Mother-Child-Health clinics and followed for 12 months. Mothers from intervention group were instructed to feed their babies (88 infants) with their head in upright position. Mothers from control group (75 infants) fed their infant regularly without any instructions . Respiratory and ear morbidity were evaluated during the following 12 month period.
primary purpose: Prevention
masking: None (Open Label)
measure: Infant morbidity
time frame: every 12 weeks visit to Mother Child Health clinic until end of 1 year follow up
description: respiratory (cough, wheezing, physician diagnosed bronchitis or pneumonia), ear (OM, SOM), prolonged fever, use of antibiotics and inhalations.
measure: Feeding position angle
time frame: at beginning and end of study (1 year follow up)
description: description of feeding position angle
arm group label: Intervention group
arm group type: Active Comparator
description: intervention: upright head position
arm group label: Control group
arm group type: No Intervention
description: no feeding position instructions
intervention type: Behavioral
intervention name: upright head position
description: Bottle feeding of infants with their head in upward and not supine head position
arm group label: Intervention group
criteria: 
gender: All
minimum age: 3 Months
maximum age: 4 Months
healthy volunteers: Accepts Healthy Volunteers
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
responsible party type: Principal Investigator
investigator affiliation: Hadassah Medical Organization
investigator full name: Avital Avraham
investigator title: Principal investigator, Associate Professor, Institute of Pulmonology, email: avital@hadassah.org.il
mesh term: Feeding and Eating Disorders
sharing ipd: No