<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/NCT03283215</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00008717</org_study_id>
    <nct_id>NCT03283215</nct_id>
  </id_info>
  <brief_title>Causes and Underlying Factors of Faltering Growth Among Infants</brief_title>
  <official_title>Causes and Underlying Factors of Faltering Growth Among Infants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</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>
      to research in the different causes of failure to thrive in children including organic and&#xD;
      non organic causes&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Altered growth velocity in infants has been traditionally described by the term (failure to&#xD;
      thrive ) . More recently the preferred terms are faltering growth ,slow weight gain or&#xD;
      undernourishment as failure to thrive has been associated with negative connotations of&#xD;
      parents failing in their job as careproviders.&#xD;
&#xD;
      The expression 'to falter' means to hesitate. Faltering growth is an observation,without&#xD;
      value judgement, of slower than expected rate of growth along an infant's previously defined&#xD;
      growth curve.&#xD;
&#xD;
      Faltering growth is a common pediatric problem with many untoward effects . More studies&#xD;
      showed that children who failed to thrive in infancy are lighter and shorter at school age&#xD;
      with adverse intellectual outcomes (corbett and drewett,2004)(Natale etal., 2014). Weight&#xD;
      faltering in the first months of life is particularly associated with these adverse effects.&#xD;
&#xD;
      Infants with faltering growth also have a higher prevalence of feeding problems (Young etal.,&#xD;
      2013).Growth failure is more common during infancy than during any other stage of life&#xD;
      because programmed growth rates and nutritional needs are high (&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">October 1, 2017</start_date>
  <completion_date type="Anticipated">September 30, 2018</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2018</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>to recognize nutritional causes of faltering growth</measure>
    <time_frame>from october 2017 to september 2018</time_frame>
    <description>o recognize nutritional causes of faltering growth by measuring weight ,height ,mid arm circumference ,skin fold thickness</description>
  </primary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Infants Aged One Month to 2 Years , Infants With Any Type of Feeding (Breast or Artificial or Weaned Attend Assiut University Children Hospital )</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>complete blood count , electrolytes</intervention_name>
    <description>it is a labarotory test to assess hemoglobin white blood count plate let</description>
    <other_name>urine analysis</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        infants aged 1month upto 2 years infants with any type of feeding (breast , artificial or&#xD;
        weaned)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        :Infants attending assiut university children hospital who are stunting(decrease height for&#xD;
        age ), wasting(decrease weight for lenght ), and underweight (decreases weight for age ) .&#xD;
        When all of theses less than -1 Z scores (normal Z-score from -1 to +1 ) . Also mid arm&#xD;
        circumference below than 115 mm&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
        Children complaining of any of the follolowing:&#xD;
&#xD;
          -  Malignancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Month</minimum_age>
    <maximum_age>2 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 29, 2017</study_first_submitted>
  <study_first_submitted_qc>September 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 14, 2017</study_first_posted>
  <last_update_submitted>September 14, 2017</last_update_submitted>
  <last_update_submitted_qc>September 14, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 15, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>marina asem shafic</investigator_full_name>
    <investigator_title>principal investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Failure to Thrive</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/NCT03283215
org study id: IRB00008717
nct id: NCT03283215
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
to research in the different causes of failure to thrive in children including organic and
      non organic causes
Altered growth velocity in infants has been traditionally described by the term (failure to
      thrive ) . More recently the preferred terms are faltering growth ,slow weight gain or
      undernourishment as failure to thrive has been associated with negative connotations of
      parents failing in their job as careproviders.

      The expression 'to falter' means to hesitate. Faltering growth is an observation,without
      value judgement, of slower than expected rate of growth along an infant's previously defined
      growth curve.

      Faltering growth is a common pediatric problem with many untoward effects . More studies
      showed that children who failed to thrive in infancy are lighter and shorter at school age
      with adverse intellectual outcomes (corbett and drewett,2004)(Natale etal., 2014). Weight
      faltering in the first months of life is particularly associated with these adverse effects.

      Infants with faltering growth also have a higher prevalence of feeding problems (Young etal.,
      2013).Growth failure is more common during infancy than during any other stage of life
      because programmed growth rates and nutritional needs are high (
observational model: Cohort
time perspective: Prospective
measure: to recognize nutritional causes of faltering growth
time frame: from october 2017 to september 2018
description: o recognize nutritional causes of faltering growth by measuring weight ,height ,mid arm circumference ,skin fold thickness
intervention type: Diagnostic Test
intervention name: complete blood count , electrolytes
description: it is a labarotory test to assess hemoglobin white blood count plate let
other name: urine analysis
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 1 Month
maximum age: 2 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: marina asem shafic
investigator title: principal investigator
mesh term: Failure to Thrive