Clincosm LogoSign in Get a demo

NEST: Neonatal Experience of Social Touch

Sponsor
Liverpool John Moores University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05039918
Collaborator
Liverpool Women's NHS Foundation Trust (Other)
40
Enrollment
1
Location
2
Arms
5.9
Anticipated Duration (Months)
6.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Affective touch
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Masking Description:
Allocation sequence will be randomised in advance by a trusted member of LJMU staff who is not involved in the study, using a computerised website to generate random numbers. The sequences will be placed in sealed opaque envelopes and stored in a secure location on-site. The use of an off-site computerised system for group allocation will decrease the risk of allocation bias. Eligible infants whose person(s) with parental responsibility have provided consent will be assigned the next available envelope which will be accessed by the lead researcher prior to the intervention.
Primary Purpose:
Basic Science
Official Title:
The Healing Power of Touch: Investigation of a Peripheral Neurological Mechanism for Reducing Pain and Enhancing Neurodevelopmental Outcomes
Anticipated Study Start Date :
Sep 1, 2021
Anticipated Primary Completion Date :
Feb 1, 2022
Anticipated Study Completion Date :
Mar 1, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Salivary cortisol [Immediately before heel prick and 20 minutes after]

    Change between cortisol levels at baseline and 20 minutes after

Secondary Outcome Measures

  1. 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

  2. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
35 Weeks to 42 Weeks
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Liverpool Women's Hospital Liverpool United Kingdom L8 7SS

Sponsors and Collaborators

  • Liverpool John Moores University
  • Liverpool Women's NHS Foundation Trust

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Liverpool John Moores University
ClinicalTrials.gov Identifier:
NCT05039918
Other Study ID Numbers:
  • 21LJMUSPONSOR051
  • 291417
First Posted:
Sep 10, 2021
Last Update Posted:
Sep 10, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Liverpool John Moores University
CT Fibres
Affective touch
Additional relevant MeSH terms:
Premature Birth

Study Results

No Results Posted as of Sep 10, 2021