PrematurityTRiPsNCT03754439
Minimising the Adverse Physiological Effects of Transportation on the Premature Infant
An observational study of Prematurity and Transfer Injury, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 4 months
- Conditions the study is for
- Prematurity, Transfer Injury, Brain Injuries
- What is being tested?
- Physiological changes to noise and vibration exposure
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 31 Oct 2018to 31 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 4 months
- All sexes
- No healthy volunteers
- Child
Study population: Neonatal patients
Who may be able to join
- Infant < 32 weeks gestation (Phase 1) or any neonatal patient (Phase 2)
- Less than 72 hours of age
- With written maternal consent
Who cannot join
- Lethal and/or major congenital abnormality known at study entry
- No realistic prospect of survival
- No informed consent
- Maternal death
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University Hospitals Nottingham NHS Trust
Nottingham, Nottinghamshire, NG7 2UH
Don Sharkey, MBBS PhD
Lara Shipley, MBChB(Hons)
About this study
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
Read more
Secondary aims of the study are to:
- 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.
- evaluate vibration and sound exposure levels using an updated transportation system modified to reduce effects.
Read the detailed description
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.
- Conditions
- Prematurity, Transfer Injury, Brain Injuries, Intraventricular Hemorrhage, Vibration; Exposure, Noise Exposure
- Being tested
- Physiological changes to noise and vibration exposure
- Medical subject headings
- Premature Birth, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiological changes to noise and vibration exposureBehavioural
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)
| Study group | Role | What they receive |
|---|---|---|
| Inborn | * Infants born within Nottingham University hospitals
* < 32 weeks gestational age
* < 72 hours old Receives: Behavioral: Physiological changes to noise and vibration exposure | |
| Transported | - 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 Receives: Behavioral: Physiological changes to noise and vibration exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vibration
Vibration exposure levels during ambulance journey or inborn measurement for period as experienced by the infant's head \& incubator (m/s2)
Measured: An average of 90 minutes
Noise
Sound exposure levels during the ambulance journey or inpatient measurement period both inside and outside the incubator (dB)
Measured: An average of 90 minutes
Secondary outcomes (6)
Intraventricular haemorrhage
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.
Measured: Until discharge from hospital, on average 3-4 months after admission.
Heart rate (beats per minute)
Heart rate will be measured either during the ambulance journey or inpatient measurement period including following journery undertaken in modified transport system
Measured: an average of 90 min
Pulse oximetery (oxygen saturation %)
Oxygen saturations will be measured either during the ambulance journey or inpatient measurement period including following journery undertaken in modified transport system
Measured: An average of 90 min
Respiratory rate (breaths per minute)
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
Measured: An average of 90 min
Near infrared spectroscopy (regional oxygen saturations)
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
Measured: An average of 90 min
Urine biochemical measurements
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.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2018
- Study start31 Oct 2018
- Primary completion31 Jul 2020 (estimated)
- Study completion31 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PrematurityStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Don Sharkey, MBBS, PhD, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03754439
- Sponsor's protocol ID
- 18015
- Acronym
- TRiPs
- Status last verified
- Nov 2018
- First submitted
- 12 Nov 2018
- Last updated
- 27 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28056712
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimising the Adverse Physiological Effects of Transportation on the Premature Infant
- ClinicalTrials.gov ID
- NCT03754439
- Acronym / sponsor ID
- TRiPs / 18015
- Conditions
- Prematurity, Transfer Injury, Brain Injuries, Intraventricular Hemorrhage, Vibration; Exposure, Noise Exposure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- 31 Oct 2018 (actual)
- Primary completion
- 31 Jul 2020 (estimated)
- Study completion
- 31 Jul 2020 (estimated)
- First posted
- 27 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- evaluate vibration and sound exposure levels using an updated transportation system modified to reduce effects.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inborn | – | Behavioral: Physiological changes to noise and vibration exposure* Infants born within Nottingham University hospitals * < 32 weeks gestational age * < 72 hours old |
| Transported | – | Behavioral: Physiological changes to noise and vibration exposure- 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 |
Who may qualify
- Ages
- Up to 4 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Neonatal patients
Key inclusion criteria (3 listed)
- Infant < 32 weeks gestation (Phase 1) or any neonatal patient (Phase 2)
- Less than 72 hours of age
- With written maternal consent
Key exclusion criteria (4 listed)
- Lethal and/or major congenital abnormality known at study entry
- No realistic prospect of survival
- No informed consent
- Maternal death
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physiological changes to noise and vibration exposurePhysiological 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) | Behavioural | Inborn, Transported |
Primary outcome
Vibration
Time frame: An average of 90 minutes
Vibration exposure levels during ambulance journey or inborn measurement for period as experienced by the infant's head \& incubator (m/s2)
Noise
Time frame: An average of 90 minutes
Sound exposure levels during the ambulance journey or inpatient measurement period both inside and outside the incubator (dB)
6 secondary outcomes
Intraventricular haemorrhage
Time frame: Until discharge from hospital, on average 3-4 months after admission.
Heart rate (beats per minute)
Time frame: an average of 90 min
Pulse oximetery (oxygen saturation %)
Time frame: An average of 90 min
Respiratory rate (breaths per minute)
Time frame: An average of 90 min
Near infrared spectroscopy (regional oxygen saturations)
Time frame: An average of 90 min
Urine biochemical measurements
Time frame: 3 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2018.
- Results publication: PubMed 28056712Blaxter 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Don Sharkey, MBBS, PhD principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prematurity and Transfer Injury, run by University of Nottingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Don Sharkey, MBBS, PhD (01158230602, Don.Sharkey@nottingham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vibration (time frame: An average of 90 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03754439, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2018.