Title: Improving neonatal outcomes with an evidence-based, multi-disciplinary developed transport system
Funder: Department of Health and Social Care

Abstract: The project is planned in 7 integrated (and overlapping) phases or workpackages. Phase 1: Prototype incubator (month 1-12) Deliverable A design for the mechanical components of the transport system that reduce noise and vibration. Objectives Optimise damping at trolley/incubator and mattress/baby interface to reduce low amplitude and high frequency vibrations Optimise materials and design for neonatal 'nest' that surrounds the baby to improve comfort, safety, access and visibility. Incorporate novel head support components of the restraint system to reduce excess noise and vibration whilst fixing life support equipment safely. Phase 2: Instrumentation Development (month 1-12) Deliverable A validated sound and vibration measurement instrumentation (learning from prototype in pilot study), providing a complete picture of how noise and vibration are transmitted through the transport system from the ambulance floor to the baby. Objectives Elicit requirements for noise and vibration monitoring and display. Design and construction of a monitoring system that meets these requirements. Validation and calibration of the monitoring system. Phase 3: Crash protection design (month 6-28) Deliverable An improved restraint design that minimises head and neck injuries in the event of a collision. Objectives Optimisation of the restraint design using computer simulations of impacts. Design and construction of a prototype restraint system and incubator mounts to allow transport in a transverse position. Validation of the prototype system using physical crash testing. Phase 4: Manufacture and Certification of prototype trolley system (month 13-18) Deliverable A certified neonatal transport trolley, mattress and restraint system that can be used for final tests in an ambulance. Objectives Produce final design Manufacture final prototype Certification of new incubator for patient use Phase 5: Clinical Noise and Vibration Evaluation (month 19-30) Deliverable Clinical validation of the novel noise and vibration reducing transport system. Primary aim to reduce vibration to -2 and noise exposure to &le;55dB on average. Objectives Obtain ethical approval for clinical study and train ambulance transport teams. Collection of preliminary data using a manikin on actual transport routes Collection of clinical data using measurements taken from patients during routine transports. Phase 6: Development of in-ambulance display of noise and vibration levels (month 19-28) Deliverable Real-time in-ambulance monitoring system to log and provide live feedback about the noise and vibration levels experienced by the patient and feed into 'mapping' database including location and speed data.. Objectives Specification of display system elicited from ambulance teams and clinicians. Design and construction of a prototype in-ambulance display system linked to the instrumentation system developed in Phase 2. In ambulance trial of feedback system (function and usability) using a manikin on standard transport routes. Phase 7: Dissemination and Commercialisation (month 6-30) Deliverables A commercial low noise and vibration neonatal transport system with supporting scientific and clinical data along with detailed user and parental review. A proposal for a major study to establish the clinical effectiveness of reducing noise and vibration on serious neurological complications including: The validated low noise and vibration transport system to act as the treatment . A study design for the RCT. An estimate of the effect size based on the pilot data gathered in this study. A cost benefit analysis of this intervention.. At least 3 patent applications with supporting proof of concept data. Clinical and academic awareness of the work through peer reviewed publications, conferences, netwroks and trade displays. Patient and public awareness of the issues raised in the study and the solutions developed by the work.

Lay abstract: The centralisation of specialist newborn care services means that many premature infants need to be transferred to such centres during the first few days of their lives with around 16,000 (UK) and 70,000 (USA) babies moved each year. Unfortunately this need occurs at the time when they are most vulnerable. Minimising the risks associated with such transport is the topic of this project. Premature babies commonly experience bleeding in their brains, intraventricular haemorrhage (IVH), which often leads to developmental complications such as low IQ, deafness, blindness and cerebral palsy. Many studies have associated IVH with transporting babies between hospitals in early life, with a general acceptance that the relatively high noise and vibration exposure (factors that are known to lead to health problems) causes stress. This in turn produces changes in brain blood flow that influences the occurrence of IVH. Consequently, whilst a transfer may save a baby s life it may also increase their likelihood of acquiring a disability. The aim of this collaborative project, between a university, a hospital and a company who make infant transport incubators, is to produce the next generation of newborn transport systems that will reduce the noise and vibration experienced to a level such that the journey is much less stressful and so the risk of brain injury is significantly reduced. We will also provide the first live feedback system for noise/vibration exposure allowing steps to be taken during the journey to further reduce exposure. In addition, this redesign of the transport incubator will provide the opportunity to address known failings in current newborn restraint mechanisms (i.e. the baby's safety belt ) that are necessary since they are currently predicted to be less effective than is desirable.

Research activity codes: 5.3 MEDICAL DEVICES
Health categories: STROKE;REPRODUCTIVE HEALTH AND CHILDBIRTH