Clinical trial NCT05039918: Neonatal Experience of Social Touch
Official title: The Healing Power of Touch: Investigation of a Peripheral Neurological Mechanism for Reducing Pain and Enhancing Neurodevelopmental Outcomes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Premature Birth
Infant Development
Pain
Keywords: CT Fibres
Affective touch
Lead sponsor: Liverpool John Moores University
Sponsor class: OTHER
Collaborators: name: Liverpool Women's NHS Foundation Trust
First posted: 2021-09-10
Enrollment: 40
Sex: ALL
Minimum age (years): 35
Maximum age (years): 42
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this randomised control trial is to determine the efficacy of CT-optimal touch (gentle stroking at 3cm/s) for newborn's who require a heel prick.

Detailed description: Newborn 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 increase salivary cortisol levels. Excluding surgery and mechanical ventilation, the most common procedural pain sources in newborns are heel-lancing and venepuncture. Tactile interventions such as skin to skin care 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; yet, dynamic touch interventions have reported to be more beneficial than static touch interventions.

A distinct type of nerve fibres, CT (C tactile) afferents, found exclusively in hairy skin, that respond optimally to gentle stroking at a velocity of \~1-10cm/s, are part of a system for processing pleasant and social rewarding touch. CT fibre activation also plays a role in pain inhibition and may be linked to the development of self-regulation, thereby, serving a neuroprotective function for the developing infant brain. Here we will investigate whether tactile stimulation at CT-optimal velocity will reduce biochemical and physiological indicators of stress in infants, as determined by salivary cortisol, heart rate and blood oxygenation levels.

Eligibility criteria: Inclusion Criteria:

* The infant is born between 35 and 42 weeks.
* Require a heel prick
* Infants may be treated with antibiotics.
* Infants may be supported with non-invasive respiratory support.
* Infants may require blood sugar monitoring.
* Infants may be monitored for jaundice or infection.
* Written consent has been obtained from the person(s) with parental responsibility.

Exclusion Criteria:

* Have a history of neurological problems.
* Receiving pharmacological analgesics.
* Known genetic condition.
* Breastfed babies
* Admitted to high dependency or intensive care
* Invasive respiratory support
* Receiving parenteral nutrition
* Has received any treatment for seizures
* Clinical instability in the judgment of nurses/midwives and paediatricians looking after the baby and mother.

Primary outcomes:
measure: Salivary cortisol
timeFrame: Immediately before heel prick and 20 minutes after
Secondary outcomes:
measure: Heart rate
timeFrame: Baseline, time of event, 20 mins after and 60 minutes after
measure: Blood oxygenation
timeFrame: Baseline, time of event, 20 mins after and 60 minutes after
Other outcomes:
Locations:
city: Liverpool
country: United Kingdom
facility: Liverpool Women's Hospital
Study officials:
affiliation: Liverpool John Moores University
name: Francis McGlone, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Manzotti A, Cerritelli F, Esteves JE, Lista G, Lombardi E, La Rocca S, Gallace A, McGlone FP, Walker SC. Dynamic touch reduces physiological arousal in preterm infants: A role for c-tactile afferents? Dev Cogn Neurosci. 2019 Oct;39:100703. doi: 10.1016/j.dcn.2019.100703. Epub 2019 Aug 21.
citation: Gursul D, Goksan S, Hartley C, Mellado GS, Moultrie F, Hoskin A, Adams E, Hathway G, Walker S, McGlone F, Slater R. Stroking modulates noxious-evoked brain activity in human infants. Curr Biol. 2018 Dec 17;28(24):R1380-R1381. doi: 10.1016/j.cub.2018.11.014.