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/NCT05977400</url>
    </required_header>
    <id_info>
      <org_study_id>NANO Follow-Up</org_study_id>
      <nct_id>NCT05977400</nct_id>
    </id_info>
    <brief_title>NICU Antibiotics and Outcomes (NANO) Follow-up Study</brief_title>
    <acronym>NANO-FU</acronym>
    <official_title>NICU Antibiotics and Outcomes Follow-Up Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sharp HealthCare</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University of Pittsburgh</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Morgan Stanley Children's Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of Louisville</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Sharp Mary Birch Hospital for Women &amp; Newborns</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Children's Hospital of Philadelphia</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Jefferson Medical College of Thomas Jefferson University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of South Florida</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Westchester Medical Center</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Yale University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>The University of Texas Health Science Center at San Antonio</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Penn State University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>State University of New York - Downstate Medical Center</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Mount Sinai Hospital, Canada</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Sharp HealthCare</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 NANO follow-up study is designed to determine whether a simple, cost-effective&#xD;
        intervention- withholding antibiotics at birth- reduces clinically relevant outcomes such as&#xD;
        behavioral and neurological impairment at 2 years of age. This study will be the largest&#xD;
        study evaluating the effects of early antibiotics in children with comprehensive measures of&#xD;
        neurodevelopment linked to genomic variants and microbiota interactions.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The multidisciplinary team launched the NANO (NICU Antibiotics and Outcomes) Trial to study&#xD;
        the longstanding clinical practice of empirically administering intravenous antibiotics to&#xD;
        very preterm infants. The NANO trial is an 802-patient,13-site randomized blinded controlled&#xD;
        trial (R01HD09757801) discerning whether administration of antibiotics within the first three&#xD;
        days of life increases the incidence of short-term, life-threatening complications among very&#xD;
        preterm infants.&#xD;
  &#xD;
        The proposed NANO follow-up study will build upon the parent NANO trial to determine whether&#xD;
        avoiding antibiotics in very preterm infants - a simple, cost-effective intervention -&#xD;
        improves neurodevelopmental and behavioral outcomes during the toddler years. Evaluation of&#xD;
        children enrolled in the proposed NANO follow-up study will include serial comprehensive,&#xD;
        standardized assessments of motor, cognitive, behavioral and adaptive outcomes. To support&#xD;
        retention and provide an important early assessment, a first virtual visit at 1 year of age&#xD;
        will include the Hammersmith Infant Neurologic Exam (HINE) and the Developmental Assessment&#xD;
        of Young Children, Second Edition (DAYC-2). A second comprehensive follow-up visit in person&#xD;
        at 2 years will include the Bayley Scales of Infant Development 4th ed., Gross Motor Function&#xD;
        Classification System, Child Behavior Checklist for ages 1.5-5, and the Modified Checklist&#xD;
        for Autism in Toddlers, Revised, with Follow-up.&#xD;
  &#xD;
        In the NANO follow-up trial, outcomes will be assessed using the Desirability of outcome&#xD;
        ranking (DOOR), an innovative, patient-centered statistical approach used in clinical trials&#xD;
        to evaluate the global benefits and risks of an intervention. The ordinal neonatal follow-up&#xD;
        endpoint composite scale, to be named neoDOOR, will be developed by both clinicians and&#xD;
        families. Stakeholder meetings will develop consensus rankings of individual and composite&#xD;
        outcomes of different severities reported by the above developmental assessments. Neonatal&#xD;
        biospecimens collected during the parent NANO trial will allow for additional exploratory&#xD;
        analyses evaluating interactions among genetics, environment, and microbiota with antibiotic&#xD;
        exposure and long-term outcomes. Through these assessments and evaluation, the investigators&#xD;
        will provide substantial evidence for the use (or non-use) of early antibiotics for very&#xD;
        preterm infants at birth.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">April 2024</start_date>
    <completion_date type="Anticipated">March 2029</completion_date>
    <primary_completion_date type="Anticipated">March 2029</primary_completion_date>
    <phase>Phase 3</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>Treatment</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Rate of neurodevelopmental impairment or Death</measure>
      <time_frame>24 months corrected gestational age</time_frame>
      <description>The first primary outcome will be a composite of newborn or childhood death OR one of following: cognitive or motor composite scores &lt;80 on the Bayley-4, Gross Motor Function Classification Score score ≥2, bilateral blindness, severe functional hearing impairment. The incidence of the composite outcome will be compared between the placebo and early antibiotic groups.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>DOOR probability Distribution</measure>
      <time_frame>24 months corrected gestational age</time_frame>
      <description>The second primary outcome will be a comparison of the DOOR probability of more desirable outcomes at 2 years using a novel ordinal endpoint scale developed during the trial. Outcomes to be included in the rank are as follows: death, cognitive/language/motor composite scores&lt;80 on the Bayley-4, Gross Motor Function Classification Score ≥2, bilateral blindness, severe functional hearing impairment, Child Behavior Checklist (CBCL) scores &gt;70, autism risk scores (MCHAT R/F) of ≥2, and medical measures, such as need for oxygen support. The distribution of the finalized neoDOOR will be compared between the placebo and empiric antibiotic groups.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">802</enrollment>
    <condition>Premature Birth</condition>
    <condition>Antibiotics</condition>
    <condition>Neurodevelopment</condition>
    <arm_group>
      <arm_group_label>Very preterm infants that receive empiric antibiotic treatment in the first 48 hours of life</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Neonates in this group will have been enrolled and randomized into the NANO trial and received a blinded 48 hour course of empiric antibiotic treatment.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Very preterm infants that do not receive empiric antibiotic treatment in the first 48 hours of life</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Neonates in this group will have been enrolled and randomized into the NANO trial and received a blinded 48 hour course of placebo.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Ampicillin</intervention_name>
      <description>Intravenous Ampicillin</description>
      <arm_group_label>Very preterm infants that receive empiric antibiotic treatment in the first 48 hours of life</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Gentamicin</intervention_name>
      <description>Intravenous Gentamicin</description>
      <arm_group_label>Very preterm infants that receive empiric antibiotic treatment in the first 48 hours of life</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Intravenous Normal Saline</description>
      <arm_group_label>Very preterm infants that do not receive empiric antibiotic treatment in the first 48 hours of life</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria: Families that have agreed to participate and are enrolled in the parent&#xD;
          NANO trial will be eligible for the NANO follow-up study. There will be no exclusions for&#xD;
          eligible children entering the follow-up study.&#xD;
  &#xD;
          Parent NANO trial Criteria:&#xD;
  &#xD;
          I. Inclusion criteria: We will enroll newborn infants with gestational age of 23.0-30.6&#xD;
          weeks born to mothers 18 years or older at participating study sites. Only inborn infants&#xD;
          at participating study sites will be eligible.&#xD;
  &#xD;
          II. Exclusion criteria:&#xD;
  &#xD;
            1. Infants at low risk for early onset sepsis-Infants born for maternal indications via&#xD;
               caesarean section with rupture of membranes within 6 hours, without attempts to induce&#xD;
               labor, and without concern for maternal infection&#xD;
  &#xD;
            2. Infants at high risk for early onset sepsis- Infants born to mothers with intrapartum&#xD;
               fever (&gt; 38ºC) or clinical diagnosis of chorioamnionitis (suspected or definite),&#xD;
               infants born to mothers with proven Group B Streptococcus colonization or indication&#xD;
               for intrapartum antibiotic prophylaxis that did not receive adequate antibiotic&#xD;
               treatment according to specialty specific guidelines, (i.e., penicillin, ampicillin,&#xD;
               cefazolin), infant born to mother with previous infant with GBS disease/infection&#xD;
  &#xD;
            3. Infants with respiratory insufficiency requiring invasive mechanical ventilation and&#xD;
               fraction of inspired oxygen&gt; 0.40 or non-invasive ventilation and fraction of inspired&#xD;
               oxygen &gt; 0.60 at time of randomization&#xD;
  &#xD;
            4. Infants with ongoing hemodynamic instability requiring vasopressors or more than one&#xD;
               fluid bolus at time of randomization&#xD;
  &#xD;
            5. Clinician concern for sepsis due to physical exam findings or clinical history of&#xD;
               mother or infant&#xD;
  &#xD;
            6. Major congenital anomalies&#xD;
  &#xD;
            7. Infants not anticipated to survive beyond 72 hours&#xD;
  &#xD;
            8. Infants who have received antibiotics prior to randomization.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>23 Weeks</minimum_age>
      <maximum_age>30 Weeks</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Anup Katheria, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Sharp HealthCare</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Anup Katheria, MD</last_name>
      <phone>8589394170</phone>
      <email>anup.katheria@sharp.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Rebecca Dorner, MD</last_name>
      <email>rebecca.dorner@sharp.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Sharp Mary Birch Hospital for Women &amp; Newborns</name>
        <address>
          <city>San Diego</city>
          <state>California</state>
          <zip>92123</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Anup C Katheria, MD</last_name>
        <phone>858-939-4170</phone>
        <email>anup.katheria@sharp.com</email>
      </contact>
      <contact_backup>
        <last_name>Felix T Ines, RCP-RRT</last_name>
        <phone>858-939-4136</phone>
        <email>felix.ines@sharp.com</email>
      </contact_backup>
      <investigator>
        <last_name>Anup C Katheria, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Yale University</name>
        <address>
          <city>New Haven</city>
          <state>Connecticut</state>
          <zip>06511</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Angela Montgomery, MD</last_name>
        <email>angela.montgomery@yale.edu</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>University of South Florida</name>
        <address>
          <city>Tampa</city>
          <state>Florida</state>
          <zip>33620</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Tara Randis, MD</last_name>
        <email>trandis@usf.edu</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>University of Louisville</name>
        <address>
          <city>Louisville</city>
          <state>Kentucky</state>
          <zip>40292</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Elizabeth Schumacher</last_name>
        <email>eschumacher@louisville.edu</email>
      </contact>
      <contact_backup>
        <last_name>Tamina Singh, MD</last_name>
        <email>tamina.singh@louisville.edu</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>State University of New York Downstate</name>
        <address>
          <city>Brooklyn</city>
          <state>New York</state>
          <zip>11203</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Jacob Aranda, MD</last_name>
        <email>jacob.aranda@downstate.edu</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Columbia University</name>
        <address>
          <city>New York</city>
          <state>New York</state>
          <zip>10027</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Rich Polin</last_name>
        <email>rap32@cumc.columbia.edu</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>University of Rochester</name>
        <address>
          <city>Rochester</city>
          <state>New York</state>
          <zip>14611</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Carl D'Angio, MD</last_name>
        <email>Carl_Dangio@URMC.Rochester.edu</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Westchester Medical Center</name>
        <address>
          <city>Valhalla</city>
          <state>New York</state>
          <zip>10595</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>The Pennsylvania State University</name>
        <address>
          <city>Hershey</city>
          <state>Pennsylvania</state>
          <zip>17033-0850</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Chintan Gandhi, MD</last_name>
        <email>cgandhi@pennstatehealth.psu.edu</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>The Children's Hospital of Philadelphia</name>
        <address>
          <city>Philadelphia</city>
          <state>Pennsylvania</state>
          <zip>19104</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Karen Puopolo, MD</last_name>
        <email>Karen.Puopolo@pennmedicine.upenn.edu</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Jefferson Medical College of Thomas Jefferson University</name>
        <address>
          <city>Philadelphia</city>
          <state>Pennsylvania</state>
          <zip>19107</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Magee-Womens Hospital</name>
        <address>
          <city>Pittsburgh</city>
          <state>Pennsylvania</state>
          <zip>15213</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>The University of Pittsburgh Medical Center</name>
        <address>
          <city>Pittsburgh</city>
          <state>Pennsylvania</state>
          <zip>15213</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Michael Morowitz, MD</last_name>
        <email>michael.morowitz@chp.edu</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>University of Texas Health Science Center at San Antonio</name>
        <address>
          <city>San Antonio</city>
          <state>Texas</state>
          <zip>78229</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Leslie-Anne Dietrich</last_name>
        <email>dietrichL3@uthscsa.edu</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Sinai Health System</name>
        <address>
          <city>Toronto</city>
          <country>Canada</country>
        </address>
      </facility>
      <contact>
        <last_name>Ashraf Kharrat, MD</last_name>
        <email>Ashraf.Kharrat@sinaihealth.ca</email>
      </contact>
    </location>
    <location_countries>
      <country>Canada</country>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>May 24, 2021</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>July 28, 2023</last_update_submitted>
    <last_update_submitted_qc>July 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 4, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Sharp HealthCare</investigator_affiliation>
      <investigator_full_name>Anup Katheria, M.D.</investigator_full_name>
      <investigator_title>PI</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Premature Birth</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Gentamicins</mesh_term>
      <mesh_term>Ampicillin</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Data will be made available per NICHD requirements (National Institute of Child Health and Human Development).</ipd_description>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_time_frame>2 years after primary publication</ipd_time_frame>
      <ipd_access_criteria>An archived dataset with documentation will be made available for additional uses by outside investigators, in collaboration with the study investigators. We will work with NICHD program staff to develop a broad data sharing plan over time.</ipd_access_criteria>
    </patient_data>
    <!-- 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/NCT05977400
  org study id: NANO Follow-Up
  nct id: NCT05977400
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  The NANO follow-up study is designed to determine whether a simple, cost-effective
        intervention- withholding antibiotics at birth- reduces clinically relevant outcomes such as
        behavioral and neurological impairment at 2 years of age. This study will be the largest
        study evaluating the effects of early antibiotics in children with comprehensive measures of
        neurodevelopment linked to genomic variants and microbiota interactions.
  The multidisciplinary team launched the NANO (NICU Antibiotics and Outcomes) Trial to study
        the longstanding clinical practice of empirically administering intravenous antibiotics to
        very preterm infants. The NANO trial is an 802-patient,13-site randomized blinded controlled
        trial (R01HD09757801) discerning whether administration of antibiotics within the first three
        days of life increases the incidence of short-term, life-threatening complications among very
        preterm infants.
  
        The proposed NANO follow-up study will build upon the parent NANO trial to determine whether
        avoiding antibiotics in very preterm infants - a simple, cost-effective intervention -
        improves neurodevelopmental and behavioral outcomes during the toddler years. Evaluation of
        children enrolled in the proposed NANO follow-up study will include serial comprehensive,
        standardized assessments of motor, cognitive, behavioral and adaptive outcomes. To support
        retention and provide an important early assessment, a first virtual visit at 1 year of age
        will include the Hammersmith Infant Neurologic Exam (HINE) and the Developmental Assessment
        of Young Children, Second Edition (DAYC-2). A second comprehensive follow-up visit in person
        at 2 years will include the Bayley Scales of Infant Development 4th ed., Gross Motor Function
        Classification System, Child Behavior Checklist for ages 1.5-5, and the Modified Checklist
        for Autism in Toddlers, Revised, with Follow-up.
  
        In the NANO follow-up trial, outcomes will be assessed using the Desirability of outcome
        ranking (DOOR), an innovative, patient-centered statistical approach used in clinical trials
        to evaluate the global benefits and risks of an intervention. The ordinal neonatal follow-up
        endpoint composite scale, to be named neoDOOR, will be developed by both clinicians and
        families. Stakeholder meetings will develop consensus rankings of individual and composite
        outcomes of different severities reported by the above developmental assessments. Neonatal
        biospecimens collected during the parent NANO trial will allow for additional exploratory
        analyses evaluating interactions among genetics, environment, and microbiota with antibiotic
        exposure and long-term outcomes. Through these assessments and evaluation, the investigators
        will provide substantial evidence for the use (or non-use) of early antibiotics for very
        preterm infants at birth.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Rate of neurodevelopmental impairment or Death
  time frame: 24 months corrected gestational age
  description: The first primary outcome will be a composite of newborn or childhood death OR one of following: cognitive or motor composite scores <80 on the Bayley-4, Gross Motor Function Classification Score score ≥2, bilateral blindness, severe functional hearing impairment. The incidence of the composite outcome will be compared between the placebo and early antibiotic groups.
  measure: DOOR probability Distribution
  time frame: 24 months corrected gestational age
  description: The second primary outcome will be a comparison of the DOOR probability of more desirable outcomes at 2 years using a novel ordinal endpoint scale developed during the trial. Outcomes to be included in the rank are as follows: death, cognitive/language/motor composite scores<80 on the Bayley-4, Gross Motor Function Classification Score ≥2, bilateral blindness, severe functional hearing impairment, Child Behavior Checklist (CBCL) scores >70, autism risk scores (MCHAT R/F) of ≥2, and medical measures, such as need for oxygen support. The distribution of the finalized neoDOOR will be compared between the placebo and empiric antibiotic groups.
  arm group label: Very preterm infants that receive empiric antibiotic treatment in the first 48 hours of life
  arm group type: Active Comparator
  description: Neonates in this group will have been enrolled and randomized into the NANO trial and received a blinded 48 hour course of empiric antibiotic treatment.
  arm group label: Very preterm infants that do not receive empiric antibiotic treatment in the first 48 hours of life
  arm group type: Placebo Comparator
  description: Neonates in this group will have been enrolled and randomized into the NANO trial and received a blinded 48 hour course of placebo.
  intervention type: Drug
  intervention name: Ampicillin
  description: Intravenous Ampicillin
  arm group label: Very preterm infants that receive empiric antibiotic treatment in the first 48 hours of life
  intervention type: Drug
  intervention name: Gentamicin
  description: Intravenous Gentamicin
  arm group label: Very preterm infants that receive empiric antibiotic treatment in the first 48 hours of life
  intervention type: Drug
  intervention name: Placebo
  description: Intravenous Normal Saline
  arm group label: Very preterm infants that do not receive empiric antibiotic treatment in the first 48 hours of life
  criteria: 
  gender: All
  minimum age: 23 Weeks
  maximum age: 30 Weeks
  healthy volunteers: No
  last name: Anup Katheria, MD
  role: Principal Investigator
  affiliation: Sharp HealthCare
  last name: Anup Katheria, MD
  phone: 8589394170
  email: anup.katheria@sharp.com
  last name: Rebecca Dorner, MD
  email: rebecca.dorner@sharp.com
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  country: Canada
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Sharp HealthCare
  investigator full name: Anup Katheria, M.D.
  investigator title: PI
  mesh term: Premature Birth
  mesh term: Gentamicins
  mesh term: Ampicillin
  sharing ipd: Yes
  ipd description: Data will be made available per NICHD requirements (National Institute of Child Health and Human Development).
  ipd info type: Statistical Analysis Plan (SAP)
  ipd time frame: 2 years after primary publication
  ipd access criteria: An archived dataset with documentation will be made available for additional uses by outside investigators, in collaboration with the study investigators. We will work with NICHD program staff to develop a broad data sharing plan over time.