<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/NCT03754439</url>
  </required_header>
  <id_info>
    <org_study_id>18015</org_study_id>
    <nct_id>NCT03754439</nct_id>
  </id_info>
  <brief_title>Minimising the Adverse Physiological Effects of Transportation on the Premature Infant</brief_title>
  <acronym>TRiPs</acronym>
  <official_title>Minimising the Adverse Physiological Effects of Transportation on the Premature Infant</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Nottingham</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Nottingham</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>
      Centralisation of neonatal intensive care has led to an increase in postnatal inter-hospital&#xD;
      transfers within the first 72 hours of life. Studies have shown transported preterm infants&#xD;
      have an increased risk of intraventricular haemorrhage compared to inborns. The cause is&#xD;
      likely multi-factorial, however, during the transportation process infants are exposed to&#xD;
      noxious stimuli (excessive noise, vibration and temperature fluctuations), which may result&#xD;
      in microscopic brain injury. However, there is a paucity of evidence to evaluate the effect&#xD;
      of noise and vibration exposure during transportation.&#xD;
&#xD;
      In this study the investigators aim to quantify the level of vibration and noise as&#xD;
      experienced by a preterm infant during inter-hospital transportation in ground ambulance in&#xD;
      the United Kingdom&#xD;
&#xD;
      Secondary aims of the study are to:&#xD;
&#xD;
      i) measure the physiological and biochemical changes that occur as a result of ambulance&#xD;
      transportation (ii) quantify microscopic brain injury through measurement of urinary S100B&#xD;
      and other biomarkers (iii) evaluate the development of intraventricular haemorrhage on&#xD;
      cranial ultrasound iv) monitor vibration and sound exposure, using a prototype measuring&#xD;
      system, during neonatal transport using both a manikin and a small cohort of neonatal&#xD;
      patients.&#xD;
&#xD;
      v) evaluate vibration and sound exposure levels using an updated transportation system&#xD;
      modified to reduce effects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There were 50 000 premature births in the United Kingdom (UK) and this number is increasing&#xD;
      each year due to changes in demographics of the childbearing population with a trend towards&#xD;
      increasing maternal age, increased uptake in fertility treatments and a greater number of&#xD;
      medically induced deliveries. This has resulted in a greater risk of preterm delivery.&#xD;
      Significant advances in neonatal intensive care have led to better survival rates with more&#xD;
      preterm infants surviving at the extremes of gestational age. However, this is not without&#xD;
      significant co-morbidity in terms of increased incidence of respiratory disease, cerebral&#xD;
      palsy, learning difficulties and behavioural problems in surviving infants. The long term&#xD;
      effect of impairment in cognitive functioning has led to an increased incidence of special&#xD;
      education needs (one to one support, special schools), lower scores of cognitive ability&#xD;
      (e.g. reading &amp; maths), a higher rate of school failure and lower up take of higher education&#xD;
      in early adulthood in these infants.&#xD;
&#xD;
      Due to the increasing preterm birth rate year strategies to reduce this level of morbidity&#xD;
      are of great importance to public health care. In 2003, neonatal services were reorganised&#xD;
      into managed clinical network leading to the development of hospitals of different specialist&#xD;
      levels of care working together with the aim to improve provision of quality care and&#xD;
      neonatal outcomes. Although this change in practice has led to an increase in survival, the&#xD;
      level of neurodisability has remained the same. Furthermore, the number of neonatal&#xD;
      inter-hospital has subsequently increased (10,000 in 2010 to 16,000 in 2016) with the&#xD;
      necessity to move premature infants to higher level centres for on-going care but also the&#xD;
      need to move infants due to lack of available cots at higher level centres.&#xD;
&#xD;
      Neonatal transport has been associated with significant morbidity in terms of severe&#xD;
      intraventricular haemorrhage (IVH). A large study of 69 000 very low birth weight infants&#xD;
      based in the USA showed infants who undergo inter-hospital transportation within the first 72&#xD;
      hours of life, a period when infants are most vulnerable to IVH, are 75% more likely to&#xD;
      develop any IVH and 44% more likely to develop severe IVH compared to inborn non-transported&#xD;
      infants. Severe IVH has been associated with both short and long term neurological morbidity&#xD;
      and mortality. It has been estimated 50 to 80% of survivors with severe IVH develop cerebral&#xD;
      palsy and 70% have cognitive impairment. Mild IVH, although not significantly associated with&#xD;
      severe impairment, has been shown result in lower developmental scores at school age, with a&#xD;
      higher percentage of infants requiring educational support compared to infants who never&#xD;
      developed IVH.&#xD;
&#xD;
      Given the significant lifelong impact of severe IVH on premature infants, their families and&#xD;
      society, current practice needs to be stratified to reduce the risk associated with&#xD;
      transportation. The causation of this additional morbidity is unknown and likely to be&#xD;
      multifactorial. However, studies that have accounted for risk factors known to be associated&#xD;
      with IVH, such as, low birth weight and intubation using multivariable regression models have&#xD;
      still found an association between transport and IVH, which raises the question whether the&#xD;
      physical process of transportation itself contributes to the development of IVH.&#xD;
&#xD;
      During transportation infants are exposed to both excessive vibration and noise. Studies have&#xD;
      shown in healthy adults excessive vibration is associated with adverse health effects, such&#xD;
      as, fatigue, headaches, circulatory disturbance and neurological disorders. Studies have&#xD;
      shown neonates are exposed to vibration levels during neonatal transport to be in the range&#xD;
      of 0.4-5.6m/s2, which would be deemed extremely uncomfortable by International Standards&#xD;
      Organization (ISO) 2631. However, a weakness of all these studies accessing vibration levels&#xD;
      during transport is in the location of the vibration sensor during measurement, which is&#xD;
      either placed on the mattress or incubator and therefore may not give a true reflection of&#xD;
      the vibration exposure the neonate's head endures.&#xD;
&#xD;
      Currently, there is a paucity of evidence to evaluate the effect of vibration on neonates&#xD;
      especially during transportation. Cerebral blood flow can be monitored via near infra-red&#xD;
      spectrometry (NIRS), which is a real time and non-invasive technique. Soul et al demonstrated&#xD;
      that continuous monitoring of regional cerebral oxygenation with NIRS can be correlated with&#xD;
      changes in systemic blood pressure and provide insight into the fluctuating nature of&#xD;
      cerebral pressure in preterm infants and hence identify infants at risk of cerebral&#xD;
      pathology. NIRS monitoring during ambulance transfer would allow real time assessment of the&#xD;
      cerebral perfusion during ambulance transfer. Additionally, simultaneous vibration and noise&#xD;
      measurement will allow correlation of exposure levels with changes in cerebral perfusion.&#xD;
&#xD;
      In addition, exposure to excessive sound, like vibration, has been shown to have adverse&#xD;
      effects in healthy adults and neonates. Excessive noise has been shown to increase heart rate&#xD;
      (HR), increase blood pressure, increase respiratory rates (RR) and alter sleep cycles in both&#xD;
      term and preterm infants. Premature infants have decreased autonomic self-regulatory&#xD;
      mechanisms and are unable to adapt to loud noxious stimuli, which predisposes them to&#xD;
      physiological instability. This instability can potentially result in fluctuations in&#xD;
      cerebral blood flow, which could increase the risk of bleeds.&#xD;
&#xD;
      Although a small number of studies have documented vibration (although of the incubator) and&#xD;
      noise exposure during transportation, none of the studies have correlated the level of&#xD;
      exposure with physiological changes or biochemical markers of neurological injury.&#xD;
      Correlation of vibration exposure as experienced by the neonatal head and noise exposure&#xD;
      within the incubator will allow the investigators to plan interventional strategies aimed at&#xD;
      reducing both vibration and noise exposure. Overall, by reducing these noxious stimuli the&#xD;
      investigators aim to reduce both subtle neurological injury and IVH to improve long term&#xD;
      neurodevelopmental outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 31, 2018</start_date>
  <completion_date type="Anticipated">July 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">July 31, 2020</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>Vibration</measure>
    <time_frame>An average of 90 minutes</time_frame>
    <description>Vibration exposure levels during ambulance journey or inborn measurement for period as experienced by the infant's head &amp; incubator (m/s2)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Noise</measure>
    <time_frame>An average of 90 minutes</time_frame>
    <description>Sound exposure levels during the ambulance journey or inpatient measurement period both inside and outside the incubator (dB)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Intraventricular haemorrhage</measure>
    <time_frame>Until discharge from hospital, on average 3-4 months after admission.</time_frame>
    <description>Development of intraventricular haemorrhage on cranial ultrasound scan, Scans will be taken pre and 24 hours post transfer for transported groups. Both transported and inborn infants will have their routine cranial ultrasound scan results documented on day 1, 3, 7 and d28 or discharge cranial ultrasound, whichever came first, from time of birth until discharge from hospital.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate (beats per minute)</measure>
    <time_frame>an average of 90 min</time_frame>
    <description>Heart rate will be measured either during the ambulance journey or inpatient measurement period including following journery undertaken in modified transport system</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pulse oximetery (oxygen saturation %)</measure>
    <time_frame>An average of 90 min</time_frame>
    <description>Oxygen saturations will be measured either during the ambulance journey or inpatient measurement period including following journery undertaken in modified transport system</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Respiratory rate (breaths per minute)</measure>
    <time_frame>An average of 90 min</time_frame>
    <description>Respiratory rate will be measured every 15 minutes either during the ambulance journey or inpatient measurement period including following journery undertaken in modified transport system</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Near infrared spectroscopy (regional oxygen saturations)</measure>
    <time_frame>An average of 90 min</time_frame>
    <description>Regional oxygen saturations via NIRS will be measured either during the ambulance journey or inpatient measurement period including following journery undertaken in modified transport system</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urine biochemical measurements</measure>
    <time_frame>3 days</time_frame>
    <description>Urine will be collected within the first 24 hours, 48 hours and 72 hours following vibration and noise exposure in the ambulance. Inborn patients will have urine collected within the first 24, 48 and 72 hours following measurement period. Urine will be used to quantify level of S100B.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Prematurity</condition>
  <condition>Transfer Injury</condition>
  <condition>Brain Injuries</condition>
  <condition>Intraventricular Hemorrhage</condition>
  <condition>Vibration; Exposure</condition>
  <condition>Noise Exposure</condition>
  <arm_group>
    <arm_group_label>Inborn</arm_group_label>
    <description>Infants born within Nottingham University hospitals&#xD;
&lt; 32 weeks gestational age&#xD;
&lt; 72 hours old</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Transported</arm_group_label>
    <description>- Infants born outside of Nottingham University Hospitals or transferred between units Phase 1 &lt; 32 weeks gestational age and &lt;72 hours old Phase 2 any gestation and age</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Physiological changes to noise and vibration exposure</intervention_name>
    <description>Physiological parameters (HR, RR, Sats, NIRS) will be observed during a period of stay on the neonatal unit (Inborn group) or during ambulance transportation (Transported group) whilst simultaneous measurement of noise and vibration exposure. Urine will be collected during the first 24, 48 and 72 hours post exposure for biochemical markers of brain injury (S100B) and stress (Cortisol)</description>
    <arm_group_label>Inborn</arm_group_label>
    <arm_group_label>Transported</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Urine&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Neonatal patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Infant &lt; 32 weeks gestation (Phase 1) or any neonatal patient (Phase 2)&#xD;
&#xD;
          -  Less than 72 hours of age&#xD;
&#xD;
          -  With written maternal consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Lethal and/or major congenital abnormality known at study entry&#xD;
&#xD;
          -  No realistic prospect of survival&#xD;
&#xD;
          -  No informed consent&#xD;
&#xD;
          -  Maternal death&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>4 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Don Sharkey, MBBS, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Nottingham</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Don Sharkey, MBBS, PhD</last_name>
    <phone>01158230602</phone>
    <email>Don.Sharkey@nottingham.ac.uk</email>
  </overall_contact>
  <location>
    <facility>
      <name>University Hospitals Nottingham NHS Trust</name>
      <address>
        <city>Nottingham</city>
        <state>Nottinghamshire</state>
        <zip>NG7 2UH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Don Sharkey, MBBS PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Lara Shipley, MBChB(Hons)</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Aarti Mistry, MBChB</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <results_reference>
    <citation>Blaxter L, Yeo M, McNally D, Crowe J, Henry C, Hill S, Mansfield N, Leslie A, Sharkey D. Neonatal head and torso vibration exposure during inter-hospital transfer. Proc Inst Mech Eng H. 2017 Feb;231(2):99-113. doi: 10.1177/0954411916680235. Epub 2017 Jan 5.</citation>
    <PMID>28056712</PMID>
  </results_reference>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 12, 2018</study_first_submitted>
  <study_first_submitted_qc>November 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>November 26, 2018</last_update_submitted>
  <last_update_submitted_qc>November 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 27, 2018</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>Brain Injuries</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03754439
org study id: 18015
nct id: NCT03754439
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Centralisation of neonatal intensive care has led to an increase in postnatal inter-hospital
      transfers within the first 72 hours of life. Studies have shown transported preterm infants
      have an increased risk of intraventricular haemorrhage compared to inborns. The cause is
      likely multi-factorial, however, during the transportation process infants are exposed to
      noxious stimuli (excessive noise, vibration and temperature fluctuations), which may result
      in microscopic brain injury. However, there is a paucity of evidence to evaluate the effect
      of noise and vibration exposure during transportation.

      In this study the investigators aim to quantify the level of vibration and noise as
      experienced by a preterm infant during inter-hospital transportation in ground ambulance in
      the United Kingdom

      Secondary aims of the study are to:

      i) measure the physiological and biochemical changes that occur as a result of ambulance
      transportation (ii) quantify microscopic brain injury through measurement of urinary S100B
      and other biomarkers (iii) evaluate the development of intraventricular haemorrhage on
      cranial ultrasound iv) monitor vibration and sound exposure, using a prototype measuring
      system, during neonatal transport using both a manikin and a small cohort of neonatal
      patients.

      v) evaluate vibration and sound exposure levels using an updated transportation system
      modified to reduce effects.
There were 50 000 premature births in the United Kingdom (UK) and this number is increasing
      each year due to changes in demographics of the childbearing population with a trend towards
      increasing maternal age, increased uptake in fertility treatments and a greater number of
      medically induced deliveries. This has resulted in a greater risk of preterm delivery.
      Significant advances in neonatal intensive care have led to better survival rates with more
      preterm infants surviving at the extremes of gestational age. However, this is not without
      significant co-morbidity in terms of increased incidence of respiratory disease, cerebral
      palsy, learning difficulties and behavioural problems in surviving infants. The long term
      effect of impairment in cognitive functioning has led to an increased incidence of special
      education needs (one to one support, special schools), lower scores of cognitive ability
      (e.g. reading & maths), a higher rate of school failure and lower up take of higher education
      in early adulthood in these infants.

      Due to the increasing preterm birth rate year strategies to reduce this level of morbidity
      are of great importance to public health care. In 2003, neonatal services were reorganised
      into managed clinical network leading to the development of hospitals of different specialist
      levels of care working together with the aim to improve provision of quality care and
      neonatal outcomes. Although this change in practice has led to an increase in survival, the
      level of neurodisability has remained the same. Furthermore, the number of neonatal
      inter-hospital has subsequently increased (10,000 in 2010 to 16,000 in 2016) with the
      necessity to move premature infants to higher level centres for on-going care but also the
      need to move infants due to lack of available cots at higher level centres.

      Neonatal transport has been associated with significant morbidity in terms of severe
      intraventricular haemorrhage (IVH). A large study of 69 000 very low birth weight infants
      based in the USA showed infants who undergo inter-hospital transportation within the first 72
      hours of life, a period when infants are most vulnerable to IVH, are 75% more likely to
      develop any IVH and 44% more likely to develop severe IVH compared to inborn non-transported
      infants. Severe IVH has been associated with both short and long term neurological morbidity
      and mortality. It has been estimated 50 to 80% of survivors with severe IVH develop cerebral
      palsy and 70% have cognitive impairment. Mild IVH, although not significantly associated with
      severe impairment, has been shown result in lower developmental scores at school age, with a
      higher percentage of infants requiring educational support compared to infants who never
      developed IVH.

      Given the significant lifelong impact of severe IVH on premature infants, their families and
      society, current practice needs to be stratified to reduce the risk associated with
      transportation. The causation of this additional morbidity is unknown and likely to be
      multifactorial. However, studies that have accounted for risk factors known to be associated
      with IVH, such as, low birth weight and intubation using multivariable regression models have
      still found an association between transport and IVH, which raises the question whether the
      physical process of transportation itself contributes to the development of IVH.

      During transportation infants are exposed to both excessive vibration and noise. Studies have
      shown in healthy adults excessive vibration is associated with adverse health effects, such
      as, fatigue, headaches, circulatory disturbance and neurological disorders. Studies have
      shown neonates are exposed to vibration levels during neonatal transport to be in the range
      of 0.4-5.6m/s2, which would be deemed extremely uncomfortable by International Standards
      Organization (ISO) 2631. However, a weakness of all these studies accessing vibration levels
      during transport is in the location of the vibration sensor during measurement, which is
      either placed on the mattress or incubator and therefore may not give a true reflection of
      the vibration exposure the neonate's head endures.

      Currently, there is a paucity of evidence to evaluate the effect of vibration on neonates
      especially during transportation. Cerebral blood flow can be monitored via near infra-red
      spectrometry (NIRS), which is a real time and non-invasive technique. Soul et al demonstrated
      that continuous monitoring of regional cerebral oxygenation with NIRS can be correlated with
      changes in systemic blood pressure and provide insight into the fluctuating nature of
      cerebral pressure in preterm infants and hence identify infants at risk of cerebral
      pathology. NIRS monitoring during ambulance transfer would allow real time assessment of the
      cerebral perfusion during ambulance transfer. Additionally, simultaneous vibration and noise
      measurement will allow correlation of exposure levels with changes in cerebral perfusion.

      In addition, exposure to excessive sound, like vibration, has been shown to have adverse
      effects in healthy adults and neonates. Excessive noise has been shown to increase heart rate
      (HR), increase blood pressure, increase respiratory rates (RR) and alter sleep cycles in both
      term and preterm infants. Premature infants have decreased autonomic self-regulatory
      mechanisms and are unable to adapt to loud noxious stimuli, which predisposes them to
      physiological instability. This instability can potentially result in fluctuations in
      cerebral blood flow, which could increase the risk of bleeds.

      Although a small number of studies have documented vibration (although of the incubator) and
      noise exposure during transportation, none of the studies have correlated the level of
      exposure with physiological changes or biochemical markers of neurological injury.
      Correlation of vibration exposure as experienced by the neonatal head and noise exposure
      within the incubator will allow the investigators to plan interventional strategies aimed at
      reducing both vibration and noise exposure. Overall, by reducing these noxious stimuli the
      investigators aim to reduce both subtle neurological injury and IVH to improve long term
      neurodevelopmental outcomes.
observational model: Cohort
time perspective: Prospective
measure: Vibration
time frame: An average of 90 minutes
description: Vibration exposure levels during ambulance journey or inborn measurement for period as experienced by the infant's head & incubator (m/s2)
measure: Noise
time frame: An average of 90 minutes
description: Sound exposure levels during the ambulance journey or inpatient measurement period both inside and outside the incubator (dB)
measure: Intraventricular haemorrhage
time frame: Until discharge from hospital, on average 3-4 months after admission.
description: Development of intraventricular haemorrhage on cranial ultrasound scan, Scans will be taken pre and 24 hours post transfer for transported groups. Both transported and inborn infants will have their routine cranial ultrasound scan results documented on day 1, 3, 7 and d28 or discharge cranial ultrasound, whichever came first, from time of birth until discharge from hospital.
measure: Heart rate (beats per minute)
time frame: an average of 90 min
description: Heart rate will be measured either during the ambulance journey or inpatient measurement period including following journery undertaken in modified transport system
measure: Pulse oximetery (oxygen saturation %)
time frame: An average of 90 min
description: Oxygen saturations will be measured either during the ambulance journey or inpatient measurement period including following journery undertaken in modified transport system
measure: Respiratory rate (breaths per minute)
time frame: An average of 90 min
description: Respiratory rate will be measured every 15 minutes either during the ambulance journey or inpatient measurement period including following journery undertaken in modified transport system
measure: Near infrared spectroscopy (regional oxygen saturations)
time frame: An average of 90 min
description: Regional oxygen saturations via NIRS will be measured either during the ambulance journey or inpatient measurement period including following journery undertaken in modified transport system
measure: Urine biochemical measurements
time frame: 3 days
description: Urine will be collected within the first 24 hours, 48 hours and 72 hours following vibration and noise exposure in the ambulance. Inborn patients will have urine collected within the first 24, 48 and 72 hours following measurement period. Urine will be used to quantify level of S100B.
arm group label: Inborn
description: Infants born within Nottingham University hospitals
< 32 weeks gestational age
< 72 hours old
arm group label: Transported
description: - Infants born outside of Nottingham University Hospitals or transferred between units Phase 1 < 32 weeks gestational age and <72 hours old Phase 2 any gestation and age
intervention type: Behavioral
intervention name: Physiological changes to noise and vibration exposure
description: Physiological parameters (HR, RR, Sats, NIRS) will be observed during a period of stay on the neonatal unit (Inborn group) or during ambulance transportation (Transported group) whilst simultaneous measurement of noise and vibration exposure. Urine will be collected during the first 24, 48 and 72 hours post exposure for biochemical markers of brain injury (S100B) and stress (Cortisol)
arm group label: Inborn
arm group label: Transported
Urine
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 4 Months
healthy volunteers: No
last name: Don Sharkey, MBBS, PhD
role: Principal Investigator
affiliation: University of Nottingham
last name: Don Sharkey, MBBS, PhD
phone: 01158230602
email: Don.Sharkey@nottingham.ac.uk
facility: 
status: Recruiting
investigator: 
investigator: 
investigator: 
country: United Kingdom
citation: Blaxter L, Yeo M, McNally D, Crowe J, Henry C, Hill S, Mansfield N, Leslie A, Sharkey D. Neonatal head and torso vibration exposure during inter-hospital transfer. Proc Inst Mech Eng H. 2017 Feb;231(2):99-113. doi: 10.1177/0954411916680235. Epub 2017 Jan 5.
PMID: 28056712
responsible party type: Sponsor
mesh term: Brain Injuries
mesh term: Hemorrhage
mesh term: Wounds and Injuries
sharing ipd: No