<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/NCT03019692</url>
  </required_header>
  <id_info>
    <org_study_id>0148-16-LND-2016121</org_study_id>
    <nct_id>NCT03019692</nct_id>
  </id_info>
  <brief_title>Longterm Outcome of Children With Neonatal Intra-Ventricular or Intra-Cranial Hemorrhage</brief_title>
  <acronym>NEONATAL ICH</acronym>
  <official_title>Longterm Outcome of Children With Neonatal Intra-Ventricular or Intra-Cranial Hemorrhage (IVH, ICH)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Laniado Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Laniado Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Intraventricular hemorrhage (IVH) is the most commonly recognized cerebral lesion on&#xD;
      ultrasound in extremely preterm infants. Papile classification is commonly used to grade the&#xD;
      severity of IVH. Grade III-IV IVH and other lesions noted on ultrasound including&#xD;
      periventricular leukomalacia (pvl) porencephaly, and ventriculomegaly are well Documented to&#xD;
      be associated with adverse neurodevelopmental outcomes.&#xD;
&#xD;
      However, the true impact of lower-grade IVH on the neurodevelopment of these extreme preterm&#xD;
      infants has not been well described.&#xD;
&#xD;
      Also Neurodevelopmental outcome for neonatal non-traumatic Intra Cranial Hemorrhage (ICH) is&#xD;
      not well established.&#xD;
&#xD;
      The aim of this study is to look retrospectively at babies with neonatal IVH or ICH and&#xD;
      follow their radiological, cognitive, motor and functional outcomes.&#xD;
&#xD;
      The study will focus on postnatal files, and on images performed as part of the child's&#xD;
      follow-up during hospitalization and after discharge.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will be performed as a Retrospective chart review with key words : IVH, ICH of&#xD;
      babies discharged from Laniado Hospital Neonatal care service or ICU, or being followed in&#xD;
      the pediatric neurosurgical clinic and prematurity/neonatology clinic of the hospital.&#xD;
&#xD;
      All charts of such children will be included, to review clinical, and radiological available&#xD;
      data.&#xD;
&#xD;
      Registration of Clinical, Radiological data as presented or submitted by the parents on&#xD;
      Neurosurgical neonatology and Neurological Followups will be performed by PI or CI and coded&#xD;
      in the data anonymously.&#xD;
&#xD;
      Follow up will be performed as clinically indicated without addition of any specific studies&#xD;
      due to the research.&#xD;
&#xD;
      The endpoints of the study:&#xD;
&#xD;
      primary endpoint:&#xD;
&#xD;
        1. How many children needed surgical intervention related to the hemorrhage (ICH, IVH)&#xD;
           secondary endpoints:&#xD;
&#xD;
        2. Clinical and functional outcome of children - REGARDING normal schooling, need for&#xD;
           assistance in ADL in difference from the parallel normal child.&#xD;
&#xD;
      correlation between the type of hemorrhage, clinical data related to gestational age and&#xD;
      weight at birth, and outcomes will be performed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">January 2027</completion_date>
  <primary_completion_date type="Anticipated">January 2027</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>need for surgery related to neonatal hemorrhage</measure>
    <time_frame>3 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>normal schooling according to age</measure>
    <time_frame>6 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>need for ADL assistance beyond acceptable per age</measure>
    <time_frame>6 years</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Neonates Premature</condition>
  <arm_group>
    <arm_group_label>enrolled babies with neonatal intracranial bleed</arm_group_label>
    <description>all babies who suffered from intra cranial or intraventricular bleed during neonatal period</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        newborns or premature babies who suffered intra-cranial or intra-ventricular hemorrhage&#xD;
        within the first 3 months after birth or before discharge after delivery&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        newborns or premature babies who suffered intra-cranial or intra-ventricular hemorrhage&#xD;
        children who are followed by PI in the neurosurgical clinic in Laniado hospital and&#xD;
        suffered from ICH or IVH and were treated elsewhere after birth -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        loss to followup within the first year after birth&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Hour</minimum_age>
    <maximum_age>3 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>LIANA ADANI BENI, MD</last_name>
    <phone>97298609336</phone>
    <email>DRLIANA.PEDNS@GMAIL.COM</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>INA FURMAN</last_name>
    <phone>97298609127</phone>
    <email>IFURMAN@LANIADO.ORG.IL</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Sharon Nechama, Laniado Hospital</name>
      <address>
        <city>Netanya</city>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nechama Sharone, MD</last_name>
      <phone>972-544303356</phone>
      <email>nsharon@laniado.org.il</email>
    </contact>
    <investigator>
      <last_name>Nechama Sharon, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 11, 2017</study_first_submitted>
  <study_first_submitted_qc>January 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 12, 2017</study_first_posted>
  <last_update_submitted>January 11, 2017</last_update_submitted>
  <last_update_submitted_qc>January 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Laniado Hospital</investigator_affiliation>
    <investigator_full_name>Laniado Hospital</investigator_full_name>
    <investigator_title>Liana.Adani</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intracranial Hemorrhages</mesh_term>
    <mesh_term>Premature Birth</mesh_term>
    <mesh_term>Hemorrhage</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/NCT03019692
org study id: 0148-16-LND-2016121
nct id: NCT03019692
lead sponsor: 
has dmc: No
Intraventricular hemorrhage (IVH) is the most commonly recognized cerebral lesion on
      ultrasound in extremely preterm infants. Papile classification is commonly used to grade the
      severity of IVH. Grade III-IV IVH and other lesions noted on ultrasound including
      periventricular leukomalacia (pvl) porencephaly, and ventriculomegaly are well Documented to
      be associated with adverse neurodevelopmental outcomes.

      However, the true impact of lower-grade IVH on the neurodevelopment of these extreme preterm
      infants has not been well described.

      Also Neurodevelopmental outcome for neonatal non-traumatic Intra Cranial Hemorrhage (ICH) is
      not well established.

      The aim of this study is to look retrospectively at babies with neonatal IVH or ICH and
      follow their radiological, cognitive, motor and functional outcomes.

      The study will focus on postnatal files, and on images performed as part of the child's
      follow-up during hospitalization and after discharge.
The study will be performed as a Retrospective chart review with key words : IVH, ICH of
      babies discharged from Laniado Hospital Neonatal care service or ICU, or being followed in
      the pediatric neurosurgical clinic and prematurity/neonatology clinic of the hospital.

      All charts of such children will be included, to review clinical, and radiological available
      data.

      Registration of Clinical, Radiological data as presented or submitted by the parents on
      Neurosurgical neonatology and Neurological Followups will be performed by PI or CI and coded
      in the data anonymously.

      Follow up will be performed as clinically indicated without addition of any specific studies
      due to the research.

      The endpoints of the study:

      primary endpoint:

        1. How many children needed surgical intervention related to the hemorrhage (ICH, IVH)
           secondary endpoints:

        2. Clinical and functional outcome of children - REGARDING normal schooling, need for
           assistance in ADL in difference from the parallel normal child.

      correlation between the type of hemorrhage, clinical data related to gestational age and
      weight at birth, and outcomes will be performed.
observational model: Cohort
time perspective: Retrospective
measure: need for surgery related to neonatal hemorrhage
time frame: 3 years
measure: normal schooling according to age
time frame: 6 years
measure: need for ADL assistance beyond acceptable per age
time frame: 6 years
arm group label: enrolled babies with neonatal intracranial bleed
description: all babies who suffered from intra cranial or intraventricular bleed during neonatal period
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 1 Hour
maximum age: 3 Months
healthy volunteers: No
last name: LIANA ADANI BENI, MD
phone: 97298609336
email: DRLIANA.PEDNS@GMAIL.COM
last name: INA FURMAN
phone: 97298609127
email: IFURMAN@LANIADO.ORG.IL
facility: 
status: Recruiting
contact: 
investigator: 
country: Israel
responsible party type: Principal Investigator
investigator affiliation: Laniado Hospital
investigator full name: Laniado Hospital
investigator title: Liana.Adani
mesh term: Intracranial Hemorrhages
mesh term: Premature Birth
mesh term: Hemorrhage