Ignite Creation Date:
2025-12-24 @ 4:58 PM
Ignite Modification Date:
2025-12-29 @ 2:56 AM
Study NCT ID:
NCT03574350
Status:
COMPLETED
Last Update Posted:
2018-07-02
First Post:
2018-06-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect on Early Somatic Growth of a Daily Kinesthetic Stimulation on Preterm Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}], 'ancestors': [{'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007185', 'term': 'Incubators'}], 'ancestors': [{'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': "The nurses who did anthropometrics measures didn't know the interventions assigned to each participant of the study, because the night shift was in charge of taking the data at 7:00 am in the mornings and the interventions were delivered in the morning shifts from 8:00 am until 5:00 pm. No interventions were delivered in the night."}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two interventions groups of 33 each, participated in the study. The first group received Kinesthetic Stimulation in Kangaroo Position (KSKP) and the second group received Kinesthetic Stimulation In incubator (KSI ), both of the interventions were delivered by parents during the period of hospitalization and at home when the infant was discharged from Hospital until 40 weeks of gestational age.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2018-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-19', 'studyFirstSubmitDate': '2018-06-04', 'studyFirstSubmitQcDate': '2018-06-19', 'lastUpdatePostDateStruct': {'date': '2018-07-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weight gain after randomization up to 5 days', 'timeFrame': 'Between randomization and 5 days post randomization', 'description': 'weight gain (g/kg/day)'}, {'measure': 'Weight gain after randomization up to 15 days', 'timeFrame': 'Between randomization and 15 days post randomization', 'description': 'weight gain (g/kg/day)'}, {'measure': 'Weight at 40 weeks of gestational age', 'timeFrame': 'at 40 weeks of gestational age', 'description': 'Weight in grames'}], 'secondaryOutcomes': [{'measure': 'Weight gain after randomization up to 5 days if randomization was made before 5 days of chronological age', 'timeFrame': 'after randomization up to 5 days if randomization was made before 5 days of chronological age', 'description': 'Weight gain(g/k/d)'}, {'measure': 'Weight gain after randomization up to 15 days if randomization was made before 5 days of chronological age', 'timeFrame': 'after randomization up to 15 days of chronological age if randomization was made before 5 days of chronological age', 'description': 'Weight gain(g/k/d)'}, {'measure': 'Weight at 40 weeks if randomization was made before 5 days of chronological age', 'timeFrame': 'at 40 weeks of gestational age if randomization was made before 5 days of chronological age', 'description': 'Weight in grames'}, {'measure': 'Weight gain after randomization up to 5 days if randomization was made between 6 and 10 days of chronological age', 'timeFrame': 'after randomization up to 5 days if randomization was made between 6 and 10 days of chronological age', 'description': 'Weight gain(g/k/d)'}, {'measure': 'Weight gain after randomization up to 15 days if randomization was made between 6 and 10 days of chronological age', 'timeFrame': 'after randomization up to 15 days if randomization was made between 6 and 10 days of chronological age', 'description': 'Weight gain(g/k/d)'}, {'measure': 'Weight at 40 weeks if randomization was made between 6 and 10 days of chronological age', 'timeFrame': 'at 40 weeks of gestational age if randomization was made between 6 and 10 days of chronological age', 'description': 'Weight in grames'}, {'measure': 'Weight gain after randomization up to 5 days if randomization was made more than 10 days of chronological age', 'timeFrame': 'after randomization up to 5 days if randomization was made more than 10 days of chronological age', 'description': 'Weight gain(g/k/d)'}, {'measure': 'Weight gain after randomization up to 15 days if randomization was made more than 10 days of chronological age', 'timeFrame': 'after randomization up to 15 days if randomization was made more than 10 days of chronological age', 'description': 'Weight gain(g/k/d)'}, {'measure': 'Weight at 40 weeks if randomization was made more than 10 days of chronological age', 'timeFrame': 'at 40 weeks of gestational age if randomization was made more than 10 days of chronological age', 'description': 'Weight in grames'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Kangaroo position', 'Kinesthetic Stimulation', 'Kangaroo Mother Care', 'Bonding'], 'conditions': ['Preterm Infant', 'Growth Acceleration', 'Neurobehavioral Manifestations']}, 'referencesModule': {'references': [{'pmid': '21570125', 'type': 'RESULT', 'citation': 'Field T, Diego M, Hernandez-Reif M. Potential underlying mechanisms for greater weight gain in massaged preterm infants. Infant Behav Dev. 2011 Jun;34(3):383-9. doi: 10.1016/j.infbeh.2010.12.001. Epub 2011 May 13.'}, {'pmid': '16027695', 'type': 'RESULT', 'citation': 'Diego MA, Field T, Hernandez-Reif M. Vagal activity, gastric motility, and weight gain in massaged preterm neonates. J Pediatr. 2005 Jul;147(1):50-5. doi: 10.1016/j.jpeds.2005.02.023.'}, {'pmid': '19420271', 'type': 'RESULT', 'citation': 'Guzzetta A, Baldini S, Bancale A, Baroncelli L, Ciucci F, Ghirri P, Putignano E, Sale A, Viegi A, Berardi N, Boldrini A, Cioni G, Maffei L. Massage accelerates brain development and the maturation of visual function. J Neurosci. 2009 May 6;29(18):6042-51. doi: 10.1523/JNEUROSCI.5548-08.2009.'}], 'seeAlsoLinks': [{'url': 'https://www.youtube.com/watch?v=WrxDLOBiiZs', 'label': 'Kinesthetic stimulation in Kangaroo Position (KSKP)'}]}, 'descriptionModule': {'briefSummary': 'Kangaroo position (KP), the essential component of the Kangaroo Mother Care (KMC) method, has been increasingly implemented, given the benefits of early skin-to-skin contact on the cerebral maturation of preterm infants. In addition it allows for parents to bond with their infants and humanize the care of fragile infants in neonatal units. Evidence on kinesthetic stimulation (KS) is scarce and currently there is no available evidence on KS during the KP. KS is associated with massage in this paper', 'detailedDescription': 'The objective is to study the impact of standardized KS delivered either in KP (KSKP) or in an incubator (KSI) on the early growth of very preterm infants.\n\nPatients and methods: Sixty six newborns ≤32 weeks of gestational age at birth received KS delivered 3 times/day during KP or in an incubator. They were randomized when the infants were considered eligibleto initiate KMC which was part of the routine care for all newborns in the Neonatal Care Unit (NCU). The primary outcome were the weight gain (g/kg/day) between randomization, 5, and 15 days after the start of the intervention and weight at 40 weeks of gestational age (term). The secondary outcomes were the same measures according to the chronological age (days of life) of the infant at randomization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '33 Weeks', 'minimumAge': '30 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Preterm infants (GA ≤33 weeks of gestation)\n* Deemed clinically stable and eligible for the KMC intervention by the neonatologist were included.\n\nExclusion Criteria:\n\n* Infants with congenital anomalies\n* Unstable during the first 15 days of life'}, 'identificationModule': {'nctId': 'NCT03574350', 'acronym': 'KISONKAP', 'briefTitle': 'Effect on Early Somatic Growth of a Daily Kinesthetic Stimulation on Preterm Infants', 'organization': {'class': 'OTHER', 'fullName': 'Kangaroo Foundation'}, 'officialTitle': 'Effect on Early Somatic Growth of a Daily Kinesthetic Stimulation on Preterm Infants Either In Kangaroo Position or in Incubator: A Randomized Control Trial', 'orgStudyIdInfo': {'id': 'KangarooF'}, 'secondaryIdInfos': [{'id': 'xxxxx', 'type': 'OTHER', 'domain': 'Université Laval'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'KS in Kangaroo Position (KSKP)', 'description': 'KS is performed while the infant is in Kangaroo Position using a lycra band to maintain the position.', 'interventionNames': ['Behavioral: KS in Kangaroo Position']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'KS in incubator (KSI)', 'description': 'The infant is in the incubator, unclothed with diaper.', 'interventionNames': ['Behavioral: KS in incubator']}], 'interventions': [{'name': 'KS in Kangaroo Position', 'type': 'BEHAVIORAL', 'otherNames': ['KSKP'], 'description': "KSKP was applied daily at regular interval corresponding to the presence of parents. Our protocol is based on the Tiffany Field's protocol with some adjustments corresponding to the constraints of the hospital : the KS was applied 3 times a day and during 15 consecutive days in the hospital or at home and parents were responsible of delivering the intervention. Sunflower oil was used. During the first 5 days, parents performed KSKP with the support of the psychologist. After day 5, parents were expected to perform KSKP by themselves but could ask for help at any moment while in hospital or in the ambulatory follow-up. The KS always began approximately 60 minutes after the feed.", 'armGroupLabels': ['KS in Kangaroo Position (KSKP)']}, {'name': 'KS in incubator', 'type': 'BEHAVIORAL', 'otherNames': ['KSI'], 'description': 'The infant is in the incubator, unclothed with diaper. Parents delivered KSI with the infant in supine position, stroking with the flats of the fingers with moderate pressure. Five 1-minute intervals, consisting of six 10-s periods of stroking, were applied to the following body regions: head, back, both legs and arms. The same process was repeated in prone position. The last part of the intervention was composed of 6 flexions of each extremity.', 'armGroupLabels': ['KS in incubator (KSI)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110231', 'city': 'Bogotá', 'state': 'Cundinamarca', 'country': 'Colombia', 'facility': 'Nathalie Charpak'}], 'overallOfficials': [{'name': 'Andrea C Aldana Acosta, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad Piloto de Colombia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nathalie Charpak', 'class': 'OTHER'}, 'collaborators': [{'name': 'Laval University', 'class': 'OTHER'}, {'name': 'Hospital Universitario San Ignacio', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Dr Andrea Aldana', 'investigatorFullName': 'Nathalie Charpak', 'investigatorAffiliation': 'Kangaroo Foundation'}}}}