Brain Injuries Clinical Trial
— TRiPsOfficial title:
Minimising the Adverse Physiological Effects of Transportation on the Premature Infant
NCT number | NCT03754439 |
Other study ID # | 18015 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | October 31, 2018 |
Est. completion date | July 31, 2020 |
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | July 31, 2020 |
Est. primary completion date | July 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 4 Months |
Eligibility |
Inclusion Criteria: - Infant < 32 weeks gestation (Phase 1) or any neonatal patient (Phase 2) - Less than 72 hours of age - With written maternal consent Exclusion Criteria: - Lethal and/or major congenital abnormality known at study entry - No realistic prospect of survival - No informed consent - Maternal death |
Country | Name | City | State |
---|---|---|---|
United Kingdom | University Hospitals Nottingham NHS Trust | Nottingham | Nottinghamshire |
Lead Sponsor | Collaborator |
---|---|
University of Nottingham |
United Kingdom,
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 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Vibration | Vibration exposure levels during ambulance journey or inborn measurement for period as experienced by the infant's head & incubator (m/s2) | An average of 90 minutes | |
Primary | Noise | Sound exposure levels during the ambulance journey or inpatient measurement period both inside and outside the incubator (dB) | An average of 90 minutes | |
Secondary | 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. | Until discharge from hospital, on average 3-4 months after admission. | |
Secondary | 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 | an average of 90 min | |
Secondary | 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 | An average of 90 min | |
Secondary | 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 | An average of 90 min | |
Secondary | 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 | An average of 90 min | |
Secondary | 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. | 3 days |
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