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/NCT06032494</url>
    </required_header>
    <id_info>
      <org_study_id>PID16761</org_study_id>
      <nct_id>NCT06032494</nct_id>
    </id_info>
    <brief_title>Investigating Changes in Vital Signs in Neonates</brief_title>
    <acronym>Neo-vital</acronym>
    <official_title>Neo-vital: Investigating Changes in Vital Signs in Neonates</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Oxford</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Oxford</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        1 in 7 babies require neonatal care. During their time in hospital their vital signs (such as&#xD;
        heart rate, breathing rate and oxygen saturation) are continuously monitored as part of&#xD;
        standard care. Many factors lead to changes in vital signs, for example, medical procedures&#xD;
        such as blood tests can result in brief increases in heart rate. Medication can also alter&#xD;
        vital signs, either as an intended effect or as a side effect. However, different infants&#xD;
        will respond in different ways to both procedures and medication. Predicting how an&#xD;
        individual infant may respond could lead to better individualised care for infants. For&#xD;
        example, using an infant's baseline vital signs to predict whether they will experience&#xD;
        cardiorespiratory side effects from a particular drug could mean that doctors could choose an&#xD;
        alternative safer treatment plan. To develop these predictive models, it is essential to&#xD;
        first better understand how infants' vital signs are affected by different procedures and&#xD;
        drugs, and how these effects are impacted by other factors such as infection, other&#xD;
        pathologies, interaction between drugs and age.&#xD;
  &#xD;
        Despite their routine use in hospital neonatal units, detailed electronic records of vital&#xD;
        signs are often not recorded. Often, only major events or average values are stated on&#xD;
        clinical records. Subtle changes in vital signs are therefore missed, and more complex&#xD;
        analysis that may reveal important predictive features within the data is not possible. In&#xD;
        this study the investigators will electronically record infant vital signs across longer time&#xD;
        periods and during a variety of clinically-necessary procedures and administration of drugs,&#xD;
        to explore how these impact vital signs and are altered by factors such as age and pathology.&#xD;
        These will be compared with control procedures, such as a nappy change, or when the infant is&#xD;
        resting in their cot or receiving skin-to-skin care.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">September 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2024</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>Change in heart rate following drug administration</measure>
      <time_frame>1 day after drug administration, compared with baseline of 1 day before drug administration.</time_frame>
      <description>To characterise the change in heart rate in infants following drug administration in a wide range of commonly used drugs in neonatal care. Drugs will only be administered as part of clinical care, no drugs are administered for research purposes</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in oxygen saturation following drug administration</measure>
      <time_frame>1 day after drug administration, compared with baseline of 1 day before drug administration.</time_frame>
      <description>To characterise the change in oxygen saturation in infants following drug administration in a wide range of commonly used drugs in neonatal care. Drugs will only be administered as part of clinical care, no drugs are administered for research purposes</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in respiratory rate following drug administration</measure>
      <time_frame>1 day after drug administration, compared with baseline of 1 day before drug administration.</time_frame>
      <description>To characterise the change in heart rate in infants following drug administration in a wide range of commonly used drugs in neonatal care. Drugs will only be administered as part of clinical care, no drugs are administered for research purposes</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in heart rate following procedures</measure>
      <time_frame>1 day after procedure, compared with baseline of 1 day before procedure.</time_frame>
      <description>To characterise the change in heart rate in infants in relation to procedures, including (but not limited to) intubation and extubation, LISA (less invasive surfactant administration), blood transfusion and acute medically-required painful procedures.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in oxygen saturation following procedures</measure>
      <time_frame>1 day after procedure, compared with baseline of 1 day before procedure.</time_frame>
      <description>To characterise the change in oxygen saturation in infants in relation to procedures, including (but not limited to) intubation and extubation, LISA (less invasive surfactant administration), blood transfusion and acute medically-required painful procedures.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in respiratory rate following procedures</measure>
      <time_frame>1 day after procedure, compared with baseline of 1 day before procedure.</time_frame>
      <description>To characterise the change in respiratory rate in infants in relation to procedures, including (but not limited to) intubation and extubation, LISA (less invasive surfactant administration), blood transfusion and acute medically-required painful procedures.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Models of drug response</measure>
      <time_frame>1 day after drug administration, compared with baseline of 1 day before drug administration.</time_frame>
      <description>Prediction of drug regimen requirements in individual infants from respiratory rate.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Models of procedure response</measure>
      <time_frame>1 day after procedure, compared with baseline of 1 day before procedure.</time_frame>
      <description>Prediction of procedure outcome in individual infants (e.g. extubation success) from respiratory rate</description>
    </secondary_outcome>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Infant</condition>
    <condition>Newborn</condition>
    <eligibility>
      <study_pop>
        <textblock>
          This single-centre prospective observational exploratory study will take place at the John&#xD;
          Radcliffe Hospital, Oxford. Participants will be infants receiving inpatient care on the&#xD;
          Newborn Care Unit.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Infants will be eligible to be included in the study if they are:&#xD;
  &#xD;
            -  Born to, or expected to be born to, a mother aged 16 or over&#xD;
  &#xD;
            -  Admitted to the Newborn Care Unit, John Radcliffe Hospital, or anticipated delivery of&#xD;
               a baby who will require admittance to the Newborn Care Unit at birth&#xD;
  &#xD;
            -  Mother given informed written consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Infants will be ineligible if the following exclusion criteria applies:&#xD;
  &#xD;
          • Known chromosomal abnormality or life-threatening congenital abnormality&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>42 Weeks</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 9, 2023</study_first_submitted>
    <study_first_submitted_qc>September 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 4, 2023</last_update_submitted>
    <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>preterm</keyword>
    <keyword>respiration</keyword>
    <keyword>oxygen saturation</keyword>
    <keyword>heart rate</keyword>
    <!-- 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/NCT06032494
  org study id: PID16761
  nct id: NCT06032494
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  1 in 7 babies require neonatal care. During their time in hospital their vital signs (such as
        heart rate, breathing rate and oxygen saturation) are continuously monitored as part of
        standard care. Many factors lead to changes in vital signs, for example, medical procedures
        such as blood tests can result in brief increases in heart rate. Medication can also alter
        vital signs, either as an intended effect or as a side effect. However, different infants
        will respond in different ways to both procedures and medication. Predicting how an
        individual infant may respond could lead to better individualised care for infants. For
        example, using an infant's baseline vital signs to predict whether they will experience
        cardiorespiratory side effects from a particular drug could mean that doctors could choose an
        alternative safer treatment plan. To develop these predictive models, it is essential to
        first better understand how infants' vital signs are affected by different procedures and
        drugs, and how these effects are impacted by other factors such as infection, other
        pathologies, interaction between drugs and age.
  
        Despite their routine use in hospital neonatal units, detailed electronic records of vital
        signs are often not recorded. Often, only major events or average values are stated on
        clinical records. Subtle changes in vital signs are therefore missed, and more complex
        analysis that may reveal important predictive features within the data is not possible. In
        this study the investigators will electronically record infant vital signs across longer time
        periods and during a variety of clinically-necessary procedures and administration of drugs,
        to explore how these impact vital signs and are altered by factors such as age and pathology.
        These will be compared with control procedures, such as a nappy change, or when the infant is
        resting in their cot or receiving skin-to-skin care.
  observational model: Cohort
  time perspective: Prospective
  measure: Change in heart rate following drug administration
  time frame: 1 day after drug administration, compared with baseline of 1 day before drug administration.
  description: To characterise the change in heart rate in infants following drug administration in a wide range of commonly used drugs in neonatal care. Drugs will only be administered as part of clinical care, no drugs are administered for research purposes
  measure: Change in oxygen saturation following drug administration
  time frame: 1 day after drug administration, compared with baseline of 1 day before drug administration.
  description: To characterise the change in oxygen saturation in infants following drug administration in a wide range of commonly used drugs in neonatal care. Drugs will only be administered as part of clinical care, no drugs are administered for research purposes
  measure: Change in respiratory rate following drug administration
  time frame: 1 day after drug administration, compared with baseline of 1 day before drug administration.
  description: To characterise the change in heart rate in infants following drug administration in a wide range of commonly used drugs in neonatal care. Drugs will only be administered as part of clinical care, no drugs are administered for research purposes
  measure: Change in heart rate following procedures
  time frame: 1 day after procedure, compared with baseline of 1 day before procedure.
  description: To characterise the change in heart rate in infants in relation to procedures, including (but not limited to) intubation and extubation, LISA (less invasive surfactant administration), blood transfusion and acute medically-required painful procedures.
  measure: Change in oxygen saturation following procedures
  time frame: 1 day after procedure, compared with baseline of 1 day before procedure.
  description: To characterise the change in oxygen saturation in infants in relation to procedures, including (but not limited to) intubation and extubation, LISA (less invasive surfactant administration), blood transfusion and acute medically-required painful procedures.
  measure: Change in respiratory rate following procedures
  time frame: 1 day after procedure, compared with baseline of 1 day before procedure.
  description: To characterise the change in respiratory rate in infants in relation to procedures, including (but not limited to) intubation and extubation, LISA (less invasive surfactant administration), blood transfusion and acute medically-required painful procedures.
  measure: Models of drug response
  time frame: 1 day after drug administration, compared with baseline of 1 day before drug administration.
  description: Prediction of drug regimen requirements in individual infants from respiratory rate.
  measure: Models of procedure response
  time frame: 1 day after procedure, compared with baseline of 1 day before procedure.
  description: Prediction of procedure outcome in individual infants (e.g. extubation success) from respiratory rate
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: 42 Weeks
  healthy volunteers: No
  responsible party type: Sponsor