Neonatal Experience of Social Touch (NEST)

September 6, 2021 updated by: Liverpool John Moores University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 months to 8 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention

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.
Behavioral: Affective touch
Gentle stroking at CT-optimal speed
No Intervention: Control
Infants who are randomised to the control group will receive standard care consistent with neonatal policy. The infant will undergo a heel prick in the incubator or crib in an identical fashion to the infants in the intervention group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Salivary cortisol
Time Frame: Immediately before heel prick and 20 minutes after
Change between cortisol levels at baseline and 20 minutes after
Immediately before heel prick and 20 minutes after

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart rate
Time Frame: 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
Baseline, time of event, 20 mins after and 60 minutes after
Blood oxygenation
Time Frame: 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
Baseline, time of event, 20 mins after and 60 minutes after

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Liverpool John Moores University

Collaborators

Liverpool Women's NHS Foundation Trust

Investigators

  • Principal Investigator: Francis McGlone, Professor, Liverpool John Moores University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2021

Primary Completion (Anticipated)

February 1, 2022

Study Completion (Anticipated)

March 1, 2022

Study Registration Dates

First Submitted

August 3, 2021

First Submitted That Met QC Criteria

September 6, 2021

First Posted (Actual)

September 10, 2021

Study Record Updates

Last Update Posted (Actual)

September 10, 2021

Last Update Submitted That Met QC Criteria

September 6, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21LJMUSPONSOR051
  • 291417 (Other Identifier: IRAS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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