Neonatal Experience of Social Touch
NEST
The Healing Power of Touch: Investigation of a Peripheral Neurological Mechanism for Reducing Pain and Enhancing Neurodevelopmental Outcomes
2 other identifiers
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 3, 2021
CompletedStudy Start
First participant enrolled
September 1, 2021
CompletedFirst Posted
Study publicly available on registry
September 10, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2022
CompletedSeptember 10, 2021
August 1, 2021
5 months
August 3, 2021
September 6, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Salivary cortisol
Change between cortisol levels at baseline and 20 minutes after
Immediately before heel prick and 20 minutes after
Secondary Outcomes (2)
Heart rate
Baseline, time of event, 20 mins after and 60 minutes after
Blood oxygenation
Baseline, time of event, 20 mins after and 60 minutes after
Study Arms (2)
Intervention
EXPERIMENTALFollowing 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.
Control
NO INTERVENTIONInfants 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Liverpool Women's Hospital
Liverpool, L8 7SS, United Kingdom
Related Publications (2)
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.
PMID: 31487608BACKGROUNDGursul 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.
PMID: 30562526BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Francis McGlone, Professor
Liverpool John Moores University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- 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.
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 3, 2021
First Posted
September 10, 2021
Study Start
September 1, 2021
Primary Completion
February 1, 2022
Study Completion
March 1, 2022
Last Updated
September 10, 2021
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will not share