Neonatal Experience of Social Touch

Pain Clinical Trial

— NEST  

Official title:

The Healing Power of Touch: Investigation of a Peripheral Neurological Mechanism for Reducing Pain and Enhancing Neurodevelopmental Outcomes

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05039918
• Other study ID #: 21LJMUSPONSOR051
• Secondary ID: 291417
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2021
• Est. completion date: March 2022

Study information

• Verified date: August 2021
• Source: Liverpool John Moores University
• Contact: Francis McGlone, Professor
• Phone: 0151 904 6332
• Email: F.P.McGlone[@]ljmu.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: March 2022
• Est. primary completion date: February 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Weeks to 42 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Infant Development
• Pain
• Premature Birth

Intervention

Behavioral:
• Affective touch
Gentle stroking at CT-optimal speed

Locations

Country	Name	City	State
United Kingdom	Liverpool Women's Hospital	Liverpool

Sponsors (2)

Lead Sponsor	Collaborator
Liverpool John Moores University	Liverpool Women's NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Salivary cortisol	Change between cortisol levels at baseline and 20 minutes after	Immediately before heel prick and 20 minutes after
Secondary	Heart rate	Change from baseline heart rate to to time of event and two post test periods	Baseline, time of event, 20 mins after and 60 minutes after
Secondary	Blood oxygenation	Change from baseline oxygenation levels to time of event and two post test periods	Baseline, time of event, 20 mins after and 60 minutes after