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

University College Cork (UCC)

Status: Completed

Conditions: Cortical Response; Pleasant Touch

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03731195

GB01/18UCC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 37+ weeks old

Volunteers: Accepts Healthy Volunteers

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