Ignite Creation Date:
2025-12-26 @ 11:10 AM
Ignite Modification Date:
2026-04-08 @ 4:39 PM
Study NCT ID:
NCT04757012
Status:
UNKNOWN
Last Update Posted:
2022-09-28
First Post:
2021-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy Study of a Device Allowing Broadcasting Maternal Voice and Heartbeat in Preterm Newborn (CALIPREM)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 32}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-04-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2023-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-26', 'studyFirstSubmitDate': '2021-01-24', 'studyFirstSubmitQcDate': '2021-02-15', 'lastUpdatePostDateStruct': {'date': '2022-09-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Heart rate variability / NIPE Index', 'timeFrame': 'Change of the NIPE index before and after intervention. Each baby is his own control. Nipe index is recorded 10 minutes before and 10 minutes after the intervention (Calinange (day 2/4/6) or nothing (day 1/3/5))', 'description': 'Recorded heart rate'}], 'secondaryOutcomes': [{'measure': 'Number of desaturation events', 'timeFrame': 'Change of the NIPE index before and after intervention. Each baby is his own control. Nipe index is recorded 10 minutes before and 10 minutes after the intervention (Calinange (day 2/4/6) or nothing (day 1/3/5))', 'description': 'Change in desaturation events before and after intervention'}, {'measure': 'Number of apnoeic events', 'timeFrame': 'Change of the NIPE index before and after intervention. Each baby is his own control. Nipe index is recorded 10 minutes before and 10 minutes after the intervention (Calinange (day 2/4/6) or nothing (day 1/3/5))', 'description': 'Change in apneic events before and after intervention'}, {'measure': 'Number of bradycardia events', 'timeFrame': 'Change of the NIPE index before and after intervention. Each baby is his own control. Nipe index is recorded 10 minutes before and 10 minutes after the intervention (Calinange (day 2/4/6) or nothing (day 1/3/5))', 'description': 'Change in bradycardia events before and after intervention'}, {'measure': 'Evaluate the benefits for the nurses', 'timeFrame': 'To be completed after each use of calinange ether on day 2, 4 and 6', 'description': 'Evaluation questionnaire'}, {'measure': 'Evaluate the benefits for the mother', 'timeFrame': 'At day 7, after the end of intervention', 'description': 'Satisfaction questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Preterm newborn', 'Maternal voice reccording', 'NIPE'], 'conditions': ['Preterm Newborn']}, 'referencesModule': {'references': [{'pmid': '23890732', 'type': 'BACKGROUND', 'citation': 'Alexandre C, De Jonckheere J, Rakza T, Mur S, Carette D, Logier R, Jeanne M, Storme L. [Impact of cocooning and maternal voice on the autonomic nervous system activity in the premature newborn infant]. Arch Pediatr. 2013 Sep;20(9):963-8. doi: 10.1016/j.arcped.2013.06.006. Epub 2013 Jul 23. French.'}, {'pmid': '23848529', 'type': 'BACKGROUND', 'citation': 'Filippa M, Devouche E, Arioni C, Imberty M, Gratier M. Live maternal speech and singing have beneficial effects on hospitalized preterm infants. Acta Paediatr. 2013 Oct;102(10):1017-20. doi: 10.1111/apa.12356. Epub 2013 Aug 8.'}, {'pmid': '31335378', 'type': 'BACKGROUND', 'citation': 'Williamson S, McGrath JM. What Are the Effects of the Maternal Voice on Preterm Infants in the NICU? Adv Neonatal Care. 2019 Aug;19(4):294-310. doi: 10.1097/ANC.0000000000000578.'}, {'pmid': '29535067', 'type': 'BACKGROUND', 'citation': "Provenzi L, Broso S, Montirosso R. Do mothers sound good? A systematic review of the effects of maternal voice exposure on preterm infants' development. Neurosci Biobehav Rev. 2018 May;88:42-50. doi: 10.1016/j.neubiorev.2018.03.009. Epub 2018 Mar 10."}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the benefits of an exposition to a maternal voice and heartbeat recording during hospital stay for preterm newborns. For that, we use of a specific neonatal device "Calinange" able to record maternal voice and heartbeats and to restore it with a sound level control. We hypothesize an improvement of the well being of the newborn under Calinange exposition.', 'detailedDescription': "Immediately after birth, preterm newborns are immersed in a hostile environment of intensive care unit with light, sound and painful stimulations. Previously, exposure to maternal voice has demonstrated improvement on infants' statements: reduction of bradycardia, desaturation events, improvement of tolerance feeding and sleep. Unfortunatly in most of the N ICU in France, the mothers' presence attendance time is reduced because of the absence of accommodation structure. The use of a specific neonatal device able to daily record maternal voice and hearbeats and to restore it when mother is gone could improve the environment and promote the well-being of the newborn."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Days', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* hospitalised premature newborn in Port-Royal NICU\n* age between 3 and 6 daysof life\n* gestational age between 27+0 and 31+6 weeks\n* hospitalisation in one bed room\n* parental consents\n* beneficiaries social security scheme\n\nExclusion Criteria\n\n* occurrence of one or more non-inclusion criteria\n* Non-inclusion Criteria:\n* Chromosomal abnormality, severe congenital malformation\n* Toxic substance consumption during pregnancy\n* Sedative medication in progress, High frequencies ventilation in progress\n* Neurological damage: intraventricular haemorrhage stage 3 and 4, bilateral and expanse periventricular leukomalacia lesions\n* Severe infectious state requiring haemodynamic support (inotropic drugs or hemissucinate)\n* Participation to a other intervention research'}, 'identificationModule': {'nctId': 'NCT04757012', 'acronym': 'CALIPREM', 'briefTitle': 'Efficacy Study of a Device Allowing Broadcasting Maternal Voice and Heartbeat in Preterm Newborn (CALIPREM)', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Pilot Study to Evaluate the Benefits of Preterm Newborn Exposition to a Maternal Voice and Heardbeat Recording During Hospital Stay', 'orgStudyIdInfo': {'id': 'En cours'}, 'secondaryIdInfos': [{'id': '2020-A01369-30', 'type': 'OTHER', 'domain': 'ID-RCB Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Calinage exposition', 'description': 'exposition to a maternal voice and heartbeat recording during hospital stay for preterm newborns at D2, D4 and D6', 'interventionNames': ['Device: calinange']}, {'type': 'NO_INTERVENTION', 'label': 'no exposition', 'description': 'No exposition to a maternal voice and heartbeat recording during hospital stay for preterm newborns at D1, D3 and D5'}], 'interventions': [{'name': 'calinange', 'type': 'DEVICE', 'description': 'calinange', 'armGroupLabels': ['Calinage exposition']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75014', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Juliana PATKAI, MD', 'role': 'CONTACT', 'email': 'juliana.patkai@aphp.fr', 'phone': '0033 1 58413645'}], 'facility': 'NICU of Port-Royal, Maternity of Port-Royal, Cochin Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Juliana PATKAI, MD', 'role': 'CONTACT', 'email': 'juliana.patkai@aphp.fr', 'phone': '033 1 58413645'}, {'name': 'Charly LARRIEU', 'role': 'CONTACT', 'email': 'charly.larrieu@aphp.fr', 'phone': '01 58 41 28 99'}], 'overallOfficials': [{'name': 'Juliana PATKAI, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Service de Médecine et Réanimation néonatales de Port-Royal APHP.Centre - Université de Paris. Site Cochin.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}