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Minimising the Adverse Physiological Effects of Transportation on the Premature Infant

NCT03754439 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2018-11-27

No results posted yet for this study

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. 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.

Conditions

  • Prematurity
  • Transfer Injury
  • Brain Injuries
  • Intraventricular Hemorrhage
  • Vibration; Exposure
  • Noise Exposure

Interventions

BEHAVIORAL

Physiological changes to noise and vibration exposure

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)

Sponsors & Collaborators

  • University of Nottingham

    lead OTHER

Principal Investigators

  • Don Sharkey, MBBS, PhD · University of Nottingham

Eligibility

Max Age
4 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-31
Primary Completion
2020-07-31
Completion
2020-07-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03754439 on ClinicalTrials.gov