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临床试验/NCT06659978
NCT06659978已完成不适用

Missing Touch 1: Human Factors Validation and Acceptability Testing of a Neuro-engineered C-tactile Stimulation Device

University of Liverpool3 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2024年1月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
34
试验地点
3
主要终点
Infant device tolerance

研究概览

简要总结

Our team have developed a mattress topper, consisting of rubber tubes attached side to side that are deflated and inflated, mimicking dynamic touch and optimal CT stimulation (3cm/s). It is connected to a microprocessor control unit and a vacuum supply. By controlling the interval between the vacuum applied to each tube in the device it generates a flow sequence as each tube relaxes back to its original state. This will feel like a stroking across the skin - but non-frictional, thereby minimising the risk of friction related skin damage.

The device is placed on top of a standard mattress in a neonatal cot. It has been manufactured in line with European Union (EU) safety requirements. It has been calibrated to mimic optimal CT fibre activation at 3cm/s, in line with previous touch intervention studies (Gursul et al., 2018; Manzotti et al., 2019). The device is made from silicone and is fully waterproof. A cleaning protocol will be implemented between each use for infection control. The waterproof sheet will be covered by a standard cot sheet.

详细描述

New-born infants are subject to several novel experiences that cause physiological, biochemical and behavioural indicators of stress; even routine and common events such as handling, changing a diaper or being bathed can induce a stress response. Tactile interventions such as skin-to-skin touch and 'still containment hold' are widely used in clinical care with apparent positive results, such as lower mean respiratory heart rate and pain measures, and higher oxygen saturation (Boundy et al., 2016; Pineda et al., 2017); yet, dynamic touch interventions have reported to be more beneficial than static touch interventions (Field, Diego, Hernandez-Reif, Deeds, & Figuereido, 2006; Manzotti et al., 2019; Vickers, Ohlsson, Lacy, & Horsley, 2004).

A distinct class of unmyelinated C-fibre sensory neurons called C-tactile afferents (CT), found exclusively in the hairy skin of the body, that respond optimally to gentle stroking touch at a velocity of ~3cm/s, are hypothesised to process the pleasant and social rewarding properties of touch (Olausson et al., 2010, McGlone et al., 2014). CT fibre activation also plays a role in pain inhibition (Gursul et al., 2018; Habig et al., 2017; Liljencrantz et al., 2017) and may also be linked to the development of self-regulation (Van Puyvelde, Gorissen, Pattyn, & McGlone, 2019), thereby serving a neuroprotective function for the developing infant brain.

Touch induced-analgesia such as skin-to-skin contact and breastfeeding are also considered as standard care non-pharmacological interventions for procedural pain in infants (Campbell-Yeo et al., 2019; Chang, Filoteo, & Nasr, 2020). However, dynamic touch is not currently acknowledged as a non-pharmacological intervention in the UK.

Touch is the first sense to develop in utero at approximately 8-weeks gestational age and is the most mature sense postnatally (Marx & Nagy, 2015). The benefits of touch are now widely recognised in postnatal care with the World Health Organization (2019) recommending that term infants engage in skin-to-skin contact with their mother or carer for at least an hour after birth due to the physiological benefits for both infant and mother.

There is limited research into the underlying mechanism behind the physiological benefits of touch, either in-utero or post-partum; however, it is hypothesised that foetal movements cause the amniotic fluid to elicit movement of lanugo (fine hair), which activates specific nerve fibres - C-Tactile afferents (CTs) to facilitate growth regulation (Bystrova, 2009).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
34 Weeks 至 42 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • Infant is born between 34- and 42-weeks gestational age.
  • Infant an in-patient at LWH based on the low dependency unit or post-natal ward.
  • Infant is born from a low-risk pregnancy with no concerns identified antenatally or postnatally.
  • Infant has been identified as eligible by neonatal clinician (junior doctor or advanced neonatal nurse practitioner).
  • Written consent has been obtained from the person(s) with parental responsibility.
  • Infant has been normoglycaemic since birth or for at least 24 hours.

排除标准

  • Known genetic condition or undergoing investigation for a suspected genetic condition.
  • Previously admitted to high dependency or intensive care.
  • Has received invasive respiratory support.
  • Has received any treatment for seizures.
  • Is receiving phototherapy.
  • Is receiving caffeine.
  • Concerns about feeding (e.g., a condition that may interfere with feeding such as cleft palate or any tube feeding at the time of the study) NB tongue tie is NOT an exclusion criterion.
  • Needing any support for thermoregulation (in incubator or using "hot cot")
  • Clinical instability in the judgment of nurses/midwives and paediatricians looking after the baby and mother.

结局指标

主要结局

Infant device tolerance

时间窗: 25 minutes

Infant's physiological responses to the device are measured by heart rate and blood oxygenation

次要结局

  • Infant comfort levels(25 minutes)
  • Parental and clinical staff acceptability(15 minutes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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