Ignite Creation Date:
2025-12-24 @ 1:59 PM
Ignite Modification Date:
2026-06-04 @ 6:55 PM
Study NCT ID:
NCT03731195
Status:
COMPLETED
Last Update Posted:
2023-12-11
First Post:
2018-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
GentleTouch (Study to Evaluate Somatosensory Evoked Potential (SSEP) Responses to Affective Touch and How it Develops in Healthy Term Babies)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2021-07-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-04', 'studyFirstSubmitDate': '2018-11-02', 'studyFirstSubmitQcDate': '2018-11-05', 'lastUpdatePostDateStruct': {'date': '2023-12-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurement and development of SSEP response to positive touch stimuli', 'timeFrame': '4 weeks', 'description': 'Standard Evoked Potentials'}], 'secondaryOutcomes': [{'measure': 'Measurement of SSEP to positive touch stimuli', 'timeFrame': '4 months', 'description': 'Standard Evoked Potentials'}, {'measure': 'Neurodevelopmental Assessment', 'timeFrame': '4 months', 'description': "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:\n\n* Foundations of Learning\n* Language and Communication\n* Eye and Hand Coordination\n* Personal-Social-Emotional\n* Gross Motor\n\nVery 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"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Baby Massage', 'SSEP'], 'conditions': ['Pleasant Touch', 'Cortical Response']}, 'referencesModule': {'references': [{'pmid': '34755881', 'type': 'RESULT', '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."}, {'pmid': '34280088', 'type': 'RESULT', '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.'}, {'pmid': '36162199', 'type': 'RESULT', '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.'}, {'pmid': '33017930', 'type': 'RESULT', '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.'}, {'pmid': '36586054', 'type': 'RESULT', '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."}, {'pmid': '36944485', 'type': 'RESULT', '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.'}, {'pmid': '36917624', 'type': 'RESULT', '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."}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '37 Weeks', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy Term infants \\>37 weeks Gestational Age', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infants born \\> 37 weeks gestation\n* Single births\n* Not requiring admission to the Neonatal Unit\n* Healthy infants without suspected congenital or metabolic anomalies\n* Written Informed Consent\n\nExclusion Criteria:\n\n* Infants born \\< 37 weeks gestation\n* Multiple births\n* Severe metabolic or genetic anomaly that would require ongoing specialist care in the infancy period.\n* Admission to the Neonatal Unit.\n* No written Informed Consent obtained'}, 'identificationModule': {'nctId': 'NCT03731195', 'briefTitle': 'GentleTouch (Study to Evaluate Somatosensory Evoked Potential (SSEP) Responses to Affective Touch and How it Develops in Healthy Term Babies)', 'organization': {'class': 'OTHER', 'fullName': 'University College Cork'}, 'officialTitle': 'GentleTouch (Study to Evaluate Somatosensory Evoked Potential (SSEP) Responses to Affective Touch and How it Develops in Healthy Term Babies)', 'orgStudyIdInfo': {'id': 'GB01/18UCC'}}, 'contactsLocationsModule': {'locations': [{'zip': 'T12 DC4A', 'city': 'Wilton', 'state': 'Cork', 'country': 'Ireland', 'facility': 'Cork University Maternity Hospital'}, {'zip': 'WC1N 1EH', 'city': 'London', 'country': 'United Kingdom', 'facility': 'University College London - Institute of Child Health (UCL-ICH)', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Ronit Pressler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University College London - Institute of Child Health (UCL-ICH)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University College Cork', 'class': 'OTHER'}, 'collaborators': [{'name': 'University College London - Institute of Child Health (UCL-ICH)', 'class': 'UNKNOWN'}, {'name': 'Science Foundation Ireland', 'class': 'OTHER'}, {'name': 'Johnson & Johnson', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Neonatal Physiology and Director of INFANT Centre', 'investigatorFullName': 'Professor Geraldine Boylan', 'investigatorAffiliation': 'University College Cork'}}}}