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Neonatal Experience of Social Touch (NEST)

Primary Purpose

Premature Birth, Infant Development, Pain

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Affective touch
Sponsored by
Liverpool John Moores University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Premature Birth focused on measuring CT Fibres, Affective touch

Eligibility Criteria

35 Weeks - 42 Weeks (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Liverpool Women's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Salivary cortisol
Change between cortisol levels at baseline and 20 minutes after

Secondary Outcome Measures

Heart rate
Change from baseline heart rate to to time of event and two post test periods
Blood oxygenation
Change from baseline oxygenation levels to time of event and two post test periods

Full Information

First Posted
August 3, 2021
Last Updated
September 6, 2021
Sponsor
Liverpool John Moores University
Collaborators
Liverpool Women's NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT05039918
Brief Title
Neonatal Experience of Social Touch
Acronym
NEST
Official Title
The Healing Power of Touch: Investigation of a Peripheral Neurological Mechanism for Reducing Pain and Enhancing Neurodevelopmental Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 2021 (Anticipated)
Primary Completion Date
February 2022 (Anticipated)
Study Completion Date
March 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Liverpool John Moores University
Collaborators
Liverpool Women's NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Birth, Infant Development, Pain
Keywords
CT Fibres, Affective touch

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
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.
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Affective touch
Intervention Description
Gentle stroking at CT-optimal speed
Primary Outcome Measure Information:
Title
Salivary cortisol
Description
Change between cortisol levels at baseline and 20 minutes after
Time Frame
Immediately before heel prick and 20 minutes after
Secondary Outcome Measure Information:
Title
Heart rate
Description
Change from baseline heart rate to to time of event and two post test periods
Time Frame
Baseline, time of event, 20 mins after and 60 minutes after
Title
Blood oxygenation
Description
Change from baseline oxygenation levels to time of event and two post test periods
Time Frame
Baseline, time of event, 20 mins after and 60 minutes after

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Weeks
Maximum Age & Unit of Time
42 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Francis McGlone, Professor
Phone
0151 904 6332
Email
F.P.McGlone@ljmu.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Laura Mulligan
Phone
0151 904 6332
Email
l.a.mulligan@2017.ljmu.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francis McGlone, Professor
Organizational Affiliation
Liverpool John Moores University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Liverpool Women's Hospital
City
Liverpool
ZIP/Postal Code
L8 7SS
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Turner, Professor
Email
mark.turner@liverpool.ac.uk
First Name & Middle Initial & Last Name & Degree
Louise Hardman
Email
louise.hardman@lwh.nhs.uk

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31487608
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.
Results Reference
background
PubMed Identifier
30562526
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.
Results Reference
background

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Neonatal Experience of Social Touch

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