Ignite Creation Date:
2025-12-25 @ 1:28 AM
Ignite Modification Date:
2026-01-05 @ 12:16 AM
Study NCT ID:
NCT04693494
Status:
COMPLETED
Last Update Posted:
2024-05-16
First Post:
2020-12-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of a Training Program for Parents of Babies in Their First Year of Life to Achieve Motor Milestones
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011596', 'term': 'Psychomotor Disorders'}], 'ancestors': [{'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': "Double blinded: spontaneous behavior of babies is evaluated, that doesn't depend of having knowledge of the intervention. Outcomes assessor doesn't know the evaluated baby group."}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Intervention and control group.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 82}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2023-01-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-13', 'studyFirstSubmitDate': '2020-12-28', 'studyFirstSubmitQcDate': '2020-12-30', 'lastUpdatePostDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Score of the Alberta Infant Motor Scale (AIMS) at month 9', 'timeFrame': '9 months old', 'description': 'AIMS is a validated observational scale for measurement of motor milestones. Higher scores mean a better outcome. Depending on the score, the percentile is obtained.'}, {'measure': 'Score of the Alberta Infant Motor Scale (AIMS) at month 12', 'timeFrame': '12 months old', 'description': 'AIMS is a validated observational scale for measurement of motor milestones. Higher scores mean a better outcome. Depending on the score, the percentile is obtained.Depending on the score, the percentile is obtained.'}, {'measure': 'Score of the Alberta Infant Motor Scale (AIMS) at month 15', 'timeFrame': '15 months old', 'description': 'AIMS is a validated observational scale for measurement of motor milestones. Higher scores mean a better outcome. Depending on the score, the percentile is obtained.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['motor milestones', 'term', 'newborn', 'motor development'], 'conditions': ['Term', 'Healthy', 'Motor Delay', 'Development, Infant']}, 'referencesModule': {'references': [{'pmid': '39891196', 'type': 'DERIVED', 'citation': 'Fernandez-Sola L, Cano-Diez B, Pons-Solaz Y, Vera-Egido B, Moreno-Gonzalez S. Effectiveness of a training program for the acquisition of motor milestones in infants: a randomized clinical trial. Ital J Pediatr. 2025 Jan 31;51(1):23. doi: 10.1186/s13052-025-01849-4.'}]}, 'descriptionModule': {'briefSummary': 'this study compares motor development of two groups of healthy term babies at the end of their first year of life. Parents of the intervention group have received a training program consisting in advices about correct positions, stimuli, how to play or how to carry their babies. The purpose of this study is to know if motor development can be improved by the environment.', 'detailedDescription': 'Infants in both groups are recruited by the principal investigator at the hospital within two to three days after birth. An initial assessment was carried out at 2 months of age.\n\nIntervention group:\n\n1. Four training sessions (before the baby is 1 month old, at 3 months, at 6, and at 9 months old) teaching the main motor milestones to get in the next 3 months and how to help infants with the correct stimuli, positions or plays; triptychs containing the main points explained at the session and links to short videos about the given bits of advice.\n2. Three evaluations of motor milestones at 9, 12, and 15 months old.\n\nControl group:\n\n1\\. Three evaluations of motor milestones at 9, 12, and 15 months old.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '9 Months', 'minimumAge': '1 Day', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy-term infants\n* Male and female\n* Apgar score of at least 7 in the first minute and at five minutes.\n* Natural or cesarean birth\n* Absence of congenital malformations or orthopedic injury\n* Absence of known congenital or genetic pathology\n* Normal neurological medical examination of the newborn at hospital discharge.\n\nExclusion Criteria:\n\n* Newborns who have required hospitalization before being enrolled.\n* Multiple births'}, 'identificationModule': {'nctId': 'NCT04693494', 'briefTitle': 'Effectiveness of a Training Program for Parents of Babies in Their First Year of Life to Achieve Motor Milestones', 'organization': {'class': 'OTHER', 'fullName': 'Universidad San Jorge'}, 'officialTitle': 'Effectiveness of a Training Program for Parents of Babies in Their First Year of Life to Achieve Motor Milestones', 'orgStudyIdInfo': {'id': 'ufernandez2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'Four training sessions (before the baby is 1 month old, at 3 months, at 6 and at 9 months old) teaching the main motor milestones to get in the next 3 months and how to help infants with the correct stimuli, positions or plays; triptychs containing the main points explained at the session and links to short videos about the given advices.\n\nThree evaluations of motor milestones at the age of 9, 12, and 15 months old', 'interventionNames': ['Other: Training program']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Three evaluations of motor milestones at the age of 9, 12, and 15 months old'}], 'interventions': [{'name': 'Training program', 'type': 'OTHER', 'description': 'Training program consisting in 4 sessions with information about milestones to achieve and advices for motor development. Triptychs and short videos containing the main points containing the main points.', 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50019', 'city': 'Zaragoza', 'state': 'Aragon', 'country': 'Spain', 'facility': 'Universidad San Jorge', 'geoPoint': {'lat': 41.65606, 'lon': -0.87734}}], 'overallOfficials': [{'name': 'Luis Fernández Sola, Physical Th', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad San Jorge'}, {'name': 'Beatriz Cano Díez, Physical Th', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Universidad San Pablo CEU'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': '5 years', 'ipdSharing': 'YES', 'description': 'All collected IPD after deidentified', 'accessCriteria': 'Información will be shared with editors or other investigators'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad San Jorge', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physical Therapist', 'investigatorFullName': 'Luis Fernandez', 'investigatorAffiliation': 'Universidad San Jorge'}}}}