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临床试验/NCT03754439
NCT03754439Unknown不适用

Minimising the Adverse Physiological Effects of Transportation on the Premature Infant

University of Nottingham1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年10月31日最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
试验地点
1
主要终点
Noise

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
— 至 4 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Infant < 32 weeks gestation (Phase 1) or any neonatal patient (Phase 2)
  • Less than 72 hours of age
  • With written maternal consent

排除标准

  • Lethal and/or major congenital abnormality known at study entry
  • No realistic prospect of survival
  • No informed consent
  • Maternal death

结局指标

主要结局

Noise

时间窗: An average of 90 minutes

Sound exposure levels during the ambulance journey or inpatient measurement period both inside and outside the incubator (dB)

Vibration

时间窗: 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)

次要结局

  • Intraventricular haemorrhage(Until discharge from hospital, on average 3-4 months after admission.)
  • Pulse oximetery (oxygen saturation %)(An average of 90 min)
  • Heart rate (beats per minute)(an average of 90 min)
  • Near infrared spectroscopy (regional oxygen saturations)(An average of 90 min)
  • Urine biochemical measurements(3 days)
  • Respiratory rate (breaths per minute)(An average of 90 min)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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