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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03731195

Enrollment

Registered

2018-11-06

Start date

2018-05-09

Completion date

2021-07-08

Last updated

2023-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cortical Response, Pleasant Touch

Keywords

Baby Massage, SSEP

Brief summary

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.

Detailed description

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

37 Weeks to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Measurement and development of SSEP response to positive touch stimuli	4 weeks	Standard Evoked Potentials

Secondary

Measure	Time frame	Description
Measurement of SSEP to positive touch stimuli	4 months	Standard Evoked Potentials
Neurodevelopmental Assessment	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

Countries

Ireland, United Kingdom

Outcome results