Neonatal Experience of Social Touch

Not Applicable

• Conditions: Infant Development; Pain; Premature Birth
• Interventions: Behavioral: Affective touch

• Registration Number: NCT05039918
• Lead Sponsor: Liverpool John Moores University

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.

Study Timeline

• Status Verified: 2021-08
• Study First Submitted: 2021-08-03
• Study Start: 2021-09
• Study First Submitted QC: 2021-09-06
• Last Update Submitted: 2021-09-06
• Study First Posted: 2021-09-10
• Last Update Posted: 2021-09-10
• Primary Completion: 2022-02
• Study Completion: 2022-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Affective touch	Following randomisation, infants will receive CT-optimal stimulation (gentle stroking) at a velocity of 3cm/s over the area which the infant will be stroked (10cm) for a duration of 10s applied proximally to the pain site prior to the heel prick. Location of the heel prick will be based on clinical judgement. There will be an inter-stimulus interval of approximately 1 second between the end of the touch and heel prick, and touch stimulation will be applied to the lower leg ipsilateral to the heel receiving the noxious stimuli. All infants will have cardio-respiratory monitoring during the intervention. All other environmental factors will be as standard care (e.g., temperature, lighting and sounds). The heel prick will be performed by a member of the infants designated clinical team who have performed the procedures in a standardised manner according to the institutional and unit policy.

Primary Outcome Measures

Name	Time	Method
Salivary cortisol	Immediately before heel prick and 20 minutes after	Change between cortisol levels at baseline and 20 minutes after

Secondary Outcome Measures

Name	Time	Method
Heart rate	Baseline, time of event, 20 mins after and 60 minutes after	Change from baseline heart rate to to time of event and two post test periods
Blood oxygenation	Baseline, time of event, 20 mins after and 60 minutes after	Change from baseline oxygenation levels to time of event and two post test periods

Trial Locations

Locations (1)

Liverpool Women's Hospital; 🇬🇧 Liverpool, United Kingdom