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Completed

NCT Number: NCT03731195

GentleTouch (Study to Evaluate Somatosensory Evoked Potential (SSEP) Responses to Affective Touch and How it Develops in Healthy Term Babies)

This study will attempt to measure the direct effect of pleasant skin touch on the developing infant brain. The massage intervention stimulates a specific class of unmyelinated C-fibres in the skin called C-touch (CT) afferents, and effects will be assessed by monitoring brain responses (GentleTouch Project) in a prospective cohort study.

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Key information

Age range

37 week and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cork University Maternity Hospital, Wilton, Cork, Ireland

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About this study

This is a single-centre proof of concept translational study to determine how and when Somato-sensory evoked potentials develop over the first 4 months of life.

The aim of this study is to explore if the investigators can measure the cortical response from the scalp of infants using standard non-invasive EEG techniques, due to the activation of CT afferents and explore how the cortical response changes in regard to age. Preform a longitudinal study on 40 subjects at approximately 4 weeks and 4 months of age. The Gentle Touch study will examine the effect of gentle positive stimuli applied to an infant's forearm on cortical responses at two time points within the first 4 months of life.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Infants born > 37 weeks gestation
  • Single births
  • Not requiring admission to the Neonatal Unit
  • Healthy infants without suspected congenital or metabolic anomalies
  • Written Informed Consent

Exclusion criteria

  • Infants born < 37 weeks gestation
  • Multiple births
  • Severe metabolic or genetic anomaly that would require ongoing specialist care in the infancy period.
  • Admission to the Neonatal Unit.
  • No written Informed Consent obtained

Treatment and study plan

Primary outcomes

  1. Measurement and development of SSEP response to positive touch stimuli

    Time frame: 4 weeks

    Standard Evoked Potentials

Secondary outcomes

  1. Measurement of SSEP to positive touch stimuli

    Time frame: 4 months

    Standard Evoked Potentials

  2. Neurodevelopmental Assessment

    Time frame: 4 months

    Griffiths Mental Development Scales (GMDS)Griffiths III provides an overall measure of a child's development, as well as an individual profile of strengths and needs across five areas:

    • Foundations of Learning
    • Language and Communication
    • Eye and Hand Coordination
    • Personal-Social-Emotional
    • Gross Motor

    Very Superior 16-20 Scaled Score >130 Development Quotient Superior 14- <16 Scaled Score 120 - 129 Development Quotient Above Average 12- <14 Scaled Score 110 - 119 Development Quotient Average 8- <12 Scaled Score 90 - 109 Development Quotient Below Average 6- <8 Scaled Score 80 - 89 Development Quotient Borderline 4- <6 Scaled Score 70 - 79 Development Quotient Extremely Low 0- <4 Scaled Score ≤ 69 Development Quotient

Sponsors and collaborators

Lead sponsor

University College Cork

Other

Collaborators

  • Johnson & Johnson
  • Science Foundation Ireland
  • University College London - Institute of Child Health (UCL-ICH)

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Nov 6, 2018
Registry last updated
Dec 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.