Clinical trial NCT03731195: GentleTouch (Study to Evaluate Somatosensory Evoked Potential (SSEP) Responses to Affective Touch and How it Develops in Healthy Term Babies)
Official title: GentleTouch (Study to Evaluate Somatosensory Evoked Potential (SSEP) Responses to Affective Touch and How it Develops in Healthy Term Babies)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pleasant Touch
Cortical Response
Keywords: Baby Massage
SSEP
Lead sponsor: University College Cork
Sponsor class: OTHER
Collaborators: name: University College London - Institute of Child Health (UCL-ICH)
name: Science Foundation Ireland
name: Johnson & Johnson
First posted: 2018-11-06
Enrollment: 90
Sex: ALL
Minimum age (years): 37
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy Term infants \>37 weeks Gestational Age

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.

Eligibility criteria: 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

Primary outcomes:
measure: Measurement and development of SSEP response to positive touch stimuli
timeFrame: 4 weeks
Secondary outcomes:
measure: Measurement of SSEP to positive touch stimuli
timeFrame: 4 months
measure: Neurodevelopmental Assessment
timeFrame: 4 months
Other outcomes:
Locations:
city: Wilton
country: Ireland
facility: Cork University Maternity Hospital
state: Cork
city: London
country: United Kingdom
facility: University College London - Institute of Child Health (UCL-ICH)
Study officials:
affiliation: University College London - Institute of Child Health (UCL-ICH)
name: Ronit Pressler, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ventura S, Mathieson SR, O'Toole JM, Livingstone V, Ryan MA, Boylan GB. Electroencephalographic sleep macrostructure and sleep spindles in early infancy. Sleep. 2022 Jan 11;45(1):zsab262. doi: 10.1093/sleep/zsab262.
citation: Wei L, Ventura S, Mathieson S, Boylan G, Lowery M, Mooney C. Spindle-AI: Sleep Spindle Number and Duration Estimation in Infant EEG. IEEE Trans Biomed Eng. 2022 Jan;69(1):465-474. doi: 10.1109/TBME.2021.3097815. Epub 2021 Dec 23.
citation: Wei L, Ventura S, Ryan MA, Mathieson S, Boylan GB, Lowery M, Mooney C. Deep-spindle: An automated sleep spindle detection system for analysis of infant sleep spindles. Comput Biol Med. 2022 Nov;150:106096. doi: 10.1016/j.compbiomed.2022.106096. Epub 2022 Sep 15.
citation: Wei L, Ventura S, Lowery M, Ryan MA, Mathieson S, Boylan GB, Mooney C. Random Forest-based Algorithm for Sleep Spindle Detection in Infant EEG. Annu Int Conf IEEE Eng Med Biol Soc. 2020 Jul;2020:58-61. doi: 10.1109/EMBC44109.2020.9176339.
citation: Lenehan SM, Fogarty L, O'Connor C, Mathieson S, Boylan GB. The Architecture of Early Childhood Sleep Over the First Two Years. Matern Child Health J. 2023 Feb;27(2):226-250. doi: 10.1007/s10995-022-03545-9. Epub 2022 Dec 31.
citation: O Sullivan MP, Livingstone V, Korotchikova I, Dempsey EM, Murray DM, Boylan GB. Reference centiles for infant sleep parameters from 4 to 16 weeks of age: findings from an Irish cohort. Arch Dis Child. 2023 Jun;108(6):481-485. doi: 10.1136/archdischild-2022-324016. Epub 2023 Mar 21.
citation: Ventura S, Mathieson SR, O'Sullivan MP, O'Toole JM, Livingstone V, Pressler RM, Dempsey EM, Murray DM, Boylan GB. Parent-led massage and sleep EEG for term-born infants: A randomized controlled parallel-group study. Dev Med Child Neurol. 2023 Oct;65(10):1395-1407. doi: 10.1111/dmcn.15565. Epub 2023 Mar 14.