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/NCT05977972</url>
    </required_header>
    <id_info>
      <org_study_id>Neonatal hypoglycemia</org_study_id>
      <nct_id>NCT05977972</nct_id>
    </id_info>
    <brief_title>Pattern of Metabolic Causes of Neonatal Hypoglycemia</brief_title>
    <official_title>Pattern of Metabolic Causes of Neonatal Hypoglycemia at Assiut University Children's Hospital</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Assiut University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Assiut University</source>
    <brief_summary>
      <textblock>
        Inborn errors of metabolism (IEM) are disorders in which there is a block at some point in&#xD;
        the normal metabolic pathway caused by a genetic defect of a specific enzyme. The number of&#xD;
        diseases in humans known to be attributable to inherited point defects in metabolism now&#xD;
        exceeds 500.While the diseases individually are rare, they collectively account for a&#xD;
        significant proportion of neonatal and childhood morbidity and mortality. Diagnosis is&#xD;
        important not only for treatment and prognostication but also for genetic counselling and&#xD;
        antenatal diagnosis in subsequent pregnancies.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Inborn errors of metabolism (IEM) are disorders in which there is a block at some point in&#xD;
        the normal metabolic pathway caused by a genetic defect of a specific enzyme. The number of&#xD;
        diseases in humans known to be attributable to inherited point defects in metabolism now&#xD;
        exceeds 500.While the diseases individually are rare, they collectively account for a&#xD;
        significant proportion of neonatal and childhood morbidity and mortality. Diagnosis is&#xD;
        important not only for treatment and prognostication but also for genetic counselling and&#xD;
        antenatal diagnosis in subsequent pregnancies.So ,the main problems facing the physician&#xD;
        caring for a sick newborn infant are to know when to consider the possibility of a metabolic&#xD;
        disorder, what to do to determine quickly and efficiently whether a child has a metabolic&#xD;
        disease, and how to treat the patient until a diagnosis is established.&#xD;
  &#xD;
        One of the clinical presentations that raises red flags of inborn error of metabolism is&#xD;
        persistent or recurrent hypoglycemia. However recognizing hypoglycemia in the newborn may be&#xD;
        difficult, because the symptoms of hypoglycemia (i.e., lethargy, poor feeding, hypothermia,&#xD;
        and seizures) are non specific. Frequent blood sugar determinations are often required to&#xD;
        confirm the suspicion of hypoglycemia. Because inborn errors of metabolism are a relatively&#xD;
        infrequent cause of neonatal hypoglycemia, other diagnostic possibilities should be&#xD;
        investigated concurrently.&#xD;
  &#xD;
        The first possibility to consider is neonatal stress secondary to perinatal asphyxia,&#xD;
        hypothermia, or intrauterine malnutrition (e.g., placental abnormalities, prematurity,&#xD;
        multiple gestations). The second consideration is the possibility of a hormonal abnormality&#xD;
        affecting insulin regulation. The inborn errors of metabolism associated with insulin&#xD;
        dysregulation include 3-hydroxacyl-CoA dehydrogenase (HADH ) deficiency and&#xD;
        hyperammonemia/hyperinsulinism (HA/HI) syndrome, both of which are diazoxide-responsive.The&#xD;
        third possibility to consider is a malformation syndrome, specifically including those&#xD;
        syndromes associated with hormonal dysregulation such as Beckwith-Wiedemann syndrome. The&#xD;
        fourth possibility is that the patient has a severe hepatocellular or cirrhotic liver disease&#xD;
        that leads non specifically to fasting hypoglycemia.&#xD;
  &#xD;
        Hypoglycemia may be associated with five categories of inborn errors of metabolism: fatty&#xD;
        acid oxidation defects gluconeogenesis defects, glycogen storage diseases, ketogenesis&#xD;
        defects, and organic acidemias . The diagnostic approach to hypoglycemia, therefore, must&#xD;
        give consideration to entities belonging to each of these categories. Usually, Krebs cycle&#xD;
        defects and mitochondrial disorders do not produce hypoglycemia, but these defects should be&#xD;
        considered when other evidence points in their direction.&#xD;
  &#xD;
        The diagnostic approach must quickly narrow the field of possible diagnoses so that specific&#xD;
        treatment can be instituted. The classic approaches to the differential diagnosis of&#xD;
        hypoglycemic disorders in children are the fasting study and specialized challenge tests.&#xD;
        These studies are, however, not feasible in newborn infants because of the significant risks&#xD;
        and technical difficulties associated with performing such studies and because of the lack of&#xD;
        control data derived from normal neonates. Alternatively, efforts to determine the cause of&#xD;
        hypoglycemia in the newborn infant should include hormonal and biochemical studies before and&#xD;
        after feeding and especially during an acute episode of hypoglycemia. Definitive diagnosis&#xD;
        might have to be postponed several months until the child is old enough to tolerate a formal&#xD;
        fasting study or specialized in vitro cell studies.&#xD;
  &#xD;
        An algorithm for diagnosing the disorders that cause neonatal hypoglycemia can be generated&#xD;
        from the results of the following studies: blood electrolytes and pH, plasma and urinary&#xD;
        ketones, plasma free fatty acids, blood lactate and pyruvate, blood ammonia, liver function&#xD;
        tests, plasma and urinary carnitine and acylcarnitine analysis, and urinary organic acids. A&#xD;
        specific diagnosis might not be made by these studies, but they are necessary for providing a&#xD;
        provisional diagnosis that can be confirmed by specific enzyme analysis.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">August 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">June 1, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Pattern of metabolic diseases in neonates with hypoglycemia</measure>
      <time_frame>Baseline</time_frame>
      <description>Detection of Pattern of metabolic diseases in neonates with hypoglycemia who admitted to Neonatal Intensive Care Unit NICU at Assiut University Children's Hospital</description>
    </primary_outcome>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Neonatal Hypoglycemia</condition>
    <condition>Metabolic Disease</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Any Neonate aged 1 day to 28 days admitted to NICU during one and half year period&#xD;
          fulfilling the inclusion criteria.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age: 1day to 28 days .&#xD;
  &#xD;
            2. Sex : Both genders .&#xD;
  &#xD;
            3. Full Term infant ≥ 37 completed weeks.&#xD;
  &#xD;
            4. Persistent hypoglycemia (Blood glucose level ≤ 45 mg/dl/2,5 mmol /L) for more than one&#xD;
               reading and not responding to IV fluids and /or oral feeding.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Age more than 28 days.&#xD;
  &#xD;
            2. Newborn with surgical problems.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>1 Day</minimum_age>
      <maximum_age>28 Days</maximum_age>
    </eligibility>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 24, 2023</study_first_submitted>
    <study_first_submitted_qc>July 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>July 24, 2023</last_update_submitted>
    <last_update_submitted_qc>July 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Assiut University</investigator_affiliation>
      <investigator_full_name>Amany Mohammed Bakry Hassan</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>Hypoglycemia</mesh_term>
      <mesh_term>Metabolic Diseases</mesh_term>
    </condition_browse>
    <!-- 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/NCT05977972
  org study id: Neonatal hypoglycemia
  nct id: NCT05977972
  lead sponsor: 
  Inborn errors of metabolism (IEM) are disorders in which there is a block at some point in
        the normal metabolic pathway caused by a genetic defect of a specific enzyme. The number of
        diseases in humans known to be attributable to inherited point defects in metabolism now
        exceeds 500.While the diseases individually are rare, they collectively account for a
        significant proportion of neonatal and childhood morbidity and mortality. Diagnosis is
        important not only for treatment and prognostication but also for genetic counselling and
        antenatal diagnosis in subsequent pregnancies.
  Inborn errors of metabolism (IEM) are disorders in which there is a block at some point in
        the normal metabolic pathway caused by a genetic defect of a specific enzyme. The number of
        diseases in humans known to be attributable to inherited point defects in metabolism now
        exceeds 500.While the diseases individually are rare, they collectively account for a
        significant proportion of neonatal and childhood morbidity and mortality. Diagnosis is
        important not only for treatment and prognostication but also for genetic counselling and
        antenatal diagnosis in subsequent pregnancies.So ,the main problems facing the physician
        caring for a sick newborn infant are to know when to consider the possibility of a metabolic
        disorder, what to do to determine quickly and efficiently whether a child has a metabolic
        disease, and how to treat the patient until a diagnosis is established.
  
        One of the clinical presentations that raises red flags of inborn error of metabolism is
        persistent or recurrent hypoglycemia. However recognizing hypoglycemia in the newborn may be
        difficult, because the symptoms of hypoglycemia (i.e., lethargy, poor feeding, hypothermia,
        and seizures) are non specific. Frequent blood sugar determinations are often required to
        confirm the suspicion of hypoglycemia. Because inborn errors of metabolism are a relatively
        infrequent cause of neonatal hypoglycemia, other diagnostic possibilities should be
        investigated concurrently.
  
        The first possibility to consider is neonatal stress secondary to perinatal asphyxia,
        hypothermia, or intrauterine malnutrition (e.g., placental abnormalities, prematurity,
        multiple gestations). The second consideration is the possibility of a hormonal abnormality
        affecting insulin regulation. The inborn errors of metabolism associated with insulin
        dysregulation include 3-hydroxacyl-CoA dehydrogenase (HADH ) deficiency and
        hyperammonemia/hyperinsulinism (HA/HI) syndrome, both of which are diazoxide-responsive.The
        third possibility to consider is a malformation syndrome, specifically including those
        syndromes associated with hormonal dysregulation such as Beckwith-Wiedemann syndrome. The
        fourth possibility is that the patient has a severe hepatocellular or cirrhotic liver disease
        that leads non specifically to fasting hypoglycemia.
  
        Hypoglycemia may be associated with five categories of inborn errors of metabolism: fatty
        acid oxidation defects gluconeogenesis defects, glycogen storage diseases, ketogenesis
        defects, and organic acidemias . The diagnostic approach to hypoglycemia, therefore, must
        give consideration to entities belonging to each of these categories. Usually, Krebs cycle
        defects and mitochondrial disorders do not produce hypoglycemia, but these defects should be
        considered when other evidence points in their direction.
  
        The diagnostic approach must quickly narrow the field of possible diagnoses so that specific
        treatment can be instituted. The classic approaches to the differential diagnosis of
        hypoglycemic disorders in children are the fasting study and specialized challenge tests.
        These studies are, however, not feasible in newborn infants because of the significant risks
        and technical difficulties associated with performing such studies and because of the lack of
        control data derived from normal neonates. Alternatively, efforts to determine the cause of
        hypoglycemia in the newborn infant should include hormonal and biochemical studies before and
        after feeding and especially during an acute episode of hypoglycemia. Definitive diagnosis
        might have to be postponed several months until the child is old enough to tolerate a formal
        fasting study or specialized in vitro cell studies.
  
        An algorithm for diagnosing the disorders that cause neonatal hypoglycemia can be generated
        from the results of the following studies: blood electrolytes and pH, plasma and urinary
        ketones, plasma free fatty acids, blood lactate and pyruvate, blood ammonia, liver function
        tests, plasma and urinary carnitine and acylcarnitine analysis, and urinary organic acids. A
        specific diagnosis might not be made by these studies, but they are necessary for providing a
        provisional diagnosis that can be confirmed by specific enzyme analysis.
  observational model: Other
  time perspective: Prospective
  measure: Pattern of metabolic diseases in neonates with hypoglycemia
  time frame: Baseline
  description: Detection of Pattern of metabolic diseases in neonates with hypoglycemia who admitted to Neonatal Intensive Care Unit NICU at Assiut University Children's Hospital
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 1 Day
  maximum age: 28 Days
  responsible party type: Principal Investigator
  investigator affiliation: Assiut University
  investigator full name: Amany Mohammed Bakry Hassan
  investigator title: Principal Investigator
  mesh term: Hypoglycemia
  mesh term: Metabolic Diseases