GentleTouch (Study to Evaluate Somatosensory Evoked Potential (SSEP) Responses to Affective Touch and How it Develops in Healthy Term Babies)
NCT ID: NCT03731195
Last Updated: 2023-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
90 participants
OBSERVATIONAL
2018-05-09
2021-07-08
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Single births
* Not requiring admission to the Neonatal Unit
* Healthy infants without suspected congenital or metabolic anomalies
* Written Informed Consent
Exclusion Criteria
* 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
37 Weeks
ALL
Yes
Sponsors
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University College London - Institute of Child Health (UCL-ICH)
UNKNOWN
Science Foundation Ireland
OTHER
Johnson & Johnson
INDUSTRY
University College Cork
OTHER
Responsible Party
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Professor Geraldine Boylan
Professor of Neonatal Physiology and Director of INFANT Centre
Principal Investigators
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Ronit Pressler, MD
Role: PRINCIPAL_INVESTIGATOR
University College London - Institute of Child Health (UCL-ICH)
Locations
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Cork University Maternity Hospital
Wilton, Cork, Ireland
University College London - Institute of Child Health (UCL-ICH)
London, , United Kingdom
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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GB01/18UCC
Identifier Type: -
Identifier Source: org_study_id