<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/NCT03253263</url>
  </required_header>
  <id_info>
    <org_study_id>OHB-607-202</org_study_id>
    <secondary_id>2018-001393-16</secondary_id>
    <secondary_id>jRCT2071200076</secondary_id>
    <nct_id>NCT03253263</nct_id>
  </id_info>
  <brief_title>A Clinical Efficacy and Safety Study of OHB-607 in Preventing Chronic Lung Disease in Extremely Premature Infants</brief_title>
  <official_title>A Phase 2b, Multicenter, Randomized, Open-label, Two-Arm Study to Evaluate the Clinical Efficacy and Safety of OHB-607 in Preventing Chronic Lung Disease in Extremely Premature Infants Compared to Standard Neonatal Care</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>OHB Neonatology Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Oak Hill Bio Ltd</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if an investigational drug can reduce the burden of&#xD;
      chronic lung disease in extremely premature infants, as compared to extremely premature&#xD;
      infants receiving standard neonatal care alone.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">May 9, 2019</start_date>
  <completion_date type="Anticipated">November 28, 2026</completion_date>
  <primary_completion_date type="Anticipated">August 28, 2026</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Reduction in the incidence of severe BPD at 36 weeks (±3 days) PMA, or death, whichever comes first as compared to the SNC group</measure>
    <time_frame>Baseline through 36 weeks postmenstrual age (PMA)</time_frame>
    <description>Severe BPD is defined by the modified NICHD severity grading</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Occurrence of severe (Grade 3 and 4) IVH at 36 weeks PMA, as assessed by cranial ultrasound as compared to the SNC group</measure>
    <time_frame>Baseline through 36 weeks postmenstrual age (PMA)</time_frame>
    <description>Severe IVH as classified according to the Volpe criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence and severity of BPD</measure>
    <time_frame>Baseline through 36 weeks postmenstrual age (PMA)</time_frame>
    <description>BPD severity is defined by the modified NICHD severity grading</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence and severity of IVH</measure>
    <time_frame>Baseline through 36 weeks postmenstrual age (PMA)</time_frame>
    <description>IVH grade as classified according to the Volpe criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neurodevelopment outcomes</measure>
    <time_frame>From 6 months CA through 24 months CA</time_frame>
    <description>Neurodevelopmental impairment, Physical and cognitive development will be measured by standardised questionnaires</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Retinopathy of Prematurity (ROP)</measure>
    <time_frame>Baseline through 40 weeks PMA</time_frame>
    <description>ROP is classified according to the International Classification</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality from birth through to 24 months CA</measure>
    <time_frame>From birth through 24 months CA</time_frame>
    <description>Mortality rates from &gt;12 hours after birth through 24 months CA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Exposure-response Pharmacokinetics/Pharmacodynamics relationships</measure>
    <time_frame>Baseline through 40 weeks PMA</time_frame>
    <description>Relationship between IGF-1 exposure and study endpoints</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">338</enrollment>
  <condition>Bronchopulmonary Dysplasia</condition>
  <condition>Chronic Lung Disease of Prematurity</condition>
  <condition>Intraventricular Hemorrhage</condition>
  <condition>Retinopathy of Prematurity (ROP)</condition>
  <arm_group>
    <arm_group_label>OHB-607</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive continuous IV infusion of OHB-607 through from birth up to PMA 29 weeks +6 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Neonatal Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard neonatal care alone will be provided.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>OHB-607</intervention_name>
    <description>Participants will receive intravenous infusion of OHB-607 from birth up to PMA 29 weeks + 6 days.</description>
    <arm_group_label>OHB-607</arm_group_label>
    <other_name>Mecasermin Rinfabate</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Written informed consents and/or assents must be signed and dated by the participant's&#xD;
             parent(s) prior to any study related procedures. The informed consent and any assents&#xD;
             for underage parents must be approved by the IRB/IEC (in accordance with local&#xD;
             regulations).&#xD;
&#xD;
          2. Written informed consents and/or assents must be signed and dated by the participant's&#xD;
             birth mother prior to providing study-related information related to birth mother&#xD;
             medical history, pregnancy and the birth of the participant. The informed consent and&#xD;
             any assents for underage birth mothers must be approved by the IRB/IEC (in accordance&#xD;
             with local regulations).&#xD;
&#xD;
          3. Subjects must be between 23 weeks +0 days and 27 weeks +6 days GA, inclusive.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Detectable major (or severe) congenital malformation identified before randomization.&#xD;
&#xD;
          2. Known or suspected chromosomal abnormality, genetic disorder, or syndrome, identified&#xD;
             before randomization, according to the investigator's opinion.&#xD;
&#xD;
          3. Hypoglycemia at Baseline (blood glucose less than (&lt;) 45 milligrams per deciliter&#xD;
             [mg/dL] or 2.5 milli moles per liter [mmol/L]) which persists in spite of glucose&#xD;
             supplementation, to exclude severe congenital abnormalities of glucose metabolism.&#xD;
&#xD;
          4. Clinically significant neurological disease identified before randomization according&#xD;
             to cranial ultrasound (hemorrhages confined to the germinal matrix are allowed) and&#xD;
             investigator's opinion.&#xD;
&#xD;
          5. Any other condition or therapy that, in the investigator's opinion, may pose a risk to&#xD;
             the participant or interfere with the participant's potential compliance with this&#xD;
             protocol or interfere with interpretation of results.&#xD;
&#xD;
          6. Current or planned participation in a clinical study of another investigational study&#xD;
             treatment, device, or procedure (participation in non-interventional studies is&#xD;
             permitted on a case-by-case basis).&#xD;
&#xD;
          7. The participant or participant's parent(s) is/are unable to comply with the protocol&#xD;
             or is unlikely to be available for long-term follow-up as determined by the&#xD;
             investigator.&#xD;
&#xD;
          8. Birth mother with active COVID-19 infection at birth or a history of severe COVID-19&#xD;
             infection (requiring intensive care hospitalization) during pregnancy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>0 Hours</minimum_age>
    <maximum_age>24 Hours</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of South Alabama Children's and Women's Hospital</name>
      <address>
        <city>Mobile</city>
        <state>Alabama</state>
        <zip>36604</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arkansas Children's Hospital</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72202-3500</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Arkansas for Medical Sciences</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72202-3500</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LAC USC Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tampa General Hospital</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Illinois at Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Hospital of South Bend</name>
      <address>
        <city>South Bend</city>
        <state>Indiana</state>
        <zip>46601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ochsner Baptist Medical Center</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Floating Hospital for Children</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boston Children's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Mississippi Medical Center</name>
      <address>
        <city>Jackson</city>
        <state>Mississippi</state>
        <zip>39216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Oklahoma Health Sciences Center</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical University of South Carolina Children Hospital</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Commonwealth University - Children's Hospital of Richmond at VCU</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sainte Justine Hospital</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mount Sinai Hospital</name>
      <address>
        <city>Toronto</city>
        <zip>M5G 1X5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oulun Yliopistollinen Sairaala</name>
      <address>
        <city>Oulu</city>
        <zip>90220</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Antoine Béclère</name>
      <address>
        <city>Clamart</city>
        <state>Hauts-de-Seine</state>
        <zip>92140</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Groupe Hospitalier Necker Enfants Malades</name>
      <address>
        <city>Paris</city>
        <zip>75015</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Freiburg</name>
      <address>
        <city>Freiburg</city>
        <state>Baden-Württemberg</state>
        <zip>79106</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitatsklinikum Leipzig</name>
      <address>
        <city>Leipzig</city>
        <state>Sachsen</state>
        <zip>04103</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Nürnberg</name>
      <address>
        <city>Nürnberg</city>
        <zip>90479</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cork University Maternity Hospital</name>
      <address>
        <city>Cork</city>
        <state>Wilton</state>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione Policlinico Universitario A Gemelli</name>
      <address>
        <city>Roma</city>
        <state>Lazio</state>
        <zip>00168</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico</name>
      <address>
        <city>Milano</city>
        <state>Lombardia</state>
        <zip>20122</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Di Padova</name>
      <address>
        <city>Padova</city>
        <state>Veneto</state>
        <zip>35128</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliero-Universitaria Careggi SOD Neonatologia e Terapia Intensiva Neonatale</name>
      <address>
        <city>Firenze</city>
        <zip>50134</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto Giannina Gaslini-Istituto Pediatrico di Ricovero e</name>
      <address>
        <city>Genova</city>
        <zip>16147</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Presidio Ospedaliero Di Treviso Ca' Foncello</name>
      <address>
        <city>Treviso</city>
        <zip>31100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kagoshima City Hospital</name>
      <address>
        <city>Kagoshima-shi</city>
        <state>Kagosima</state>
        <zip>890-0075</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nagano Children's Hospital</name>
      <address>
        <city>Azumino</city>
        <state>Nagano</state>
        <zip>399-8205</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kurashiki Central Hospital</name>
      <address>
        <city>Kurashiki-shi</city>
        <state>Okayama</state>
        <zip>710-0052</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saitama Medical Center</name>
      <address>
        <city>Kawagoe-shi</city>
        <state>Saitama</state>
        <zip>350-8550</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osaka Women's and Children's Hospital</name>
      <address>
        <city>Izumi</city>
        <state>Ôsaka</state>
        <zip>594-1101</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maastricht University Medical Center</name>
      <address>
        <city>Maastricht</city>
        <state>Limburg</state>
        <zip>6229 HX</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Academisch Medisch Centrum Amsterdam</name>
      <address>
        <city>Amsterdam-Zuidoost</city>
        <state>Noord-Holland</state>
        <zip>1105 AZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wilhelmina Children Hospital-University Medical Center Utrecht</name>
      <address>
        <city>Utrecht</city>
        <zip>3584 EA</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Garcia de Orta</name>
      <address>
        <city>Almada</city>
        <zip>2801-951</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maternidade Alfredo da Costa</name>
      <address>
        <city>Lisboa</city>
        <zip>1069-089</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Hospitalar Lisboa</name>
      <address>
        <city>Lisboa</city>
        <zip>1649-035</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Materno Infantil do Norte - Centro Hospital Universitario do Porto, E.P.E.</name>
      <address>
        <city>Porto</city>
        <zip>4050-651</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General Universitario Dr. Balmis</name>
      <address>
        <city>Alicante</city>
        <zip>03010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Skanes Universitetssjukhus</name>
      <address>
        <city>Lund</city>
        <zip>SE-22185</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Karolinska Solna</name>
      <address>
        <city>Stockholm</city>
        <zip>171 76</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Norfolk and Norwich University Hospital</name>
      <address>
        <city>Norwich</city>
        <state>Norfolk</state>
        <zip>NR4 7UY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ashford and St. Peter's Hospitals NHS Trust - St. Peter's Hospital</name>
      <address>
        <city>Chertsey</city>
        <state>Surrey</state>
        <zip>KT16 0PZ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Cambridge</name>
      <address>
        <city>Cambridge</city>
        <zip>CB2 0QQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University College London</name>
      <address>
        <city>London</city>
        <zip>NW1 2BU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chelsea and Westminster NHS Trust</name>
      <address>
        <city>London</city>
        <zip>SW3 6JJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Mary's Hospital</name>
      <address>
        <city>Manchester</city>
        <zip>M13 9WL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>Finland</country>
    <country>France</country>
    <country>Germany</country>
    <country>Ireland</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Netherlands</country>
    <country>Portugal</country>
    <country>Spain</country>
    <country>Sweden</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Israel</country>
    <country>Korea, Republic of</country>
  </removed_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>August 15, 2017</study_first_submitted>
  <study_first_submitted_qc>August 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 17, 2017</study_first_posted>
  <last_update_submitted>December 9, 2022</last_update_submitted>
  <last_update_submitted_qc>December 9, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 12, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</mesh_term>
    <mesh_term>Bronchopulmonary Dysplasia</mesh_term>
    <mesh_term>Retinopathy of Prematurity</mesh_term>
    <mesh_term>Premature Birth</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mecasermin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>De-identified individual participant data from this particular study will not be shared in order to minimize the risk that individual patients could be re-identified, given that there are limited numbers of study participants at each study site per year.</ipd_description>
  </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/NCT03253263
org study id: OHB-607-202
secondary id: 2018-001393-16
secondary id: jRCT2071200076
nct id: NCT03253263
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to determine if an investigational drug can reduce the burden of
      chronic lung disease in extremely premature infants, as compared to extremely premature
      infants receiving standard neonatal care alone.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Reduction in the incidence of severe BPD at 36 weeks (±3 days) PMA, or death, whichever comes first as compared to the SNC group
time frame: Baseline through 36 weeks postmenstrual age (PMA)
description: Severe BPD is defined by the modified NICHD severity grading
measure: Occurrence of severe (Grade 3 and 4) IVH at 36 weeks PMA, as assessed by cranial ultrasound as compared to the SNC group
time frame: Baseline through 36 weeks postmenstrual age (PMA)
description: Severe IVH as classified according to the Volpe criteria
measure: Incidence and severity of BPD
time frame: Baseline through 36 weeks postmenstrual age (PMA)
description: BPD severity is defined by the modified NICHD severity grading
measure: Incidence and severity of IVH
time frame: Baseline through 36 weeks postmenstrual age (PMA)
description: IVH grade as classified according to the Volpe criteria
measure: Neurodevelopment outcomes
time frame: From 6 months CA through 24 months CA
description: Neurodevelopmental impairment, Physical and cognitive development will be measured by standardised questionnaires
measure: Incidence of Retinopathy of Prematurity (ROP)
time frame: Baseline through 40 weeks PMA
description: ROP is classified according to the International Classification
measure: Mortality from birth through to 24 months CA
time frame: From birth through 24 months CA
description: Mortality rates from >12 hours after birth through 24 months CA
measure: Exposure-response Pharmacokinetics/Pharmacodynamics relationships
time frame: Baseline through 40 weeks PMA
description: Relationship between IGF-1 exposure and study endpoints
arm group label: OHB-607
arm group type: Experimental
description: Participants will receive continuous IV infusion of OHB-607 through from birth up to PMA 29 weeks +6 days.
arm group label: Standard Neonatal Care
arm group type: No Intervention
description: Standard neonatal care alone will be provided.
intervention type: Drug
intervention name: OHB-607
description: Participants will receive intravenous infusion of OHB-607 from birth up to PMA 29 weeks + 6 days.
arm group label: OHB-607
other name: Mecasermin Rinfabate
criteria: 
gender: All
minimum age: 0 Hours
maximum age: 24 Hours
healthy volunteers: No
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country: Canada
country: Finland
country: France
country: Germany
country: Ireland
country: Italy
country: Japan
country: Netherlands
country: Portugal
country: Spain
country: Sweden
country: United Kingdom
country: United States
country: Israel
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Lung Diseases
mesh term: Bronchopulmonary Dysplasia
mesh term: Retinopathy of Prematurity
mesh term: Premature Birth
mesh term: Hemorrhage
mesh term: Mecasermin
sharing ipd: No
ipd description: De-identified individual participant data from this particular study will not be shared in order to minimize the risk that individual patients could be re-identified, given that there are limited numbers of study participants at each study site per year.