Ignite Creation Date:
2025-12-24 @ 9:12 PM
Ignite Modification Date:
2026-01-26 @ 9:25 PM
Study NCT ID:
NCT03690804
Status:
COMPLETED
Last Update Posted:
2018-10-31
First Post:
2018-09-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Autonomic Co-regulation Between Newborn and Parent During Kangaroo Care Sessions in Neonatal Intensive Care Units
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2018-10-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-30', 'studyFirstSubmitDate': '2018-09-24', 'studyFirstSubmitQcDate': '2018-09-28', 'lastUpdatePostDateStruct': {'date': '2018-10-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change form baseline high frequency index (HFnu) of variability RR short-term heart rate (HRV) in the frequency domain, from the parent and the child at 1 hour', 'timeFrame': 'Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.', 'description': 'Measured during the ECG recording'}], 'secondaryOutcomes': [{'measure': 'Evaluation of the NIPE index of comfort and discomfort (Mdoloris Medical Systems ®) for the newborn', 'timeFrame': 'Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.', 'description': 'NIPΣ (neonatal index of parasympathetic activity) : evaluate the comfort of the newborn during the skin-to-skin session.\n\nNIPΣ is physiologically above 60%. The threshold of discomfort in the newborn would correspond to a value \\<60.'}, {'measure': 'Evaluation of the ANI index of comfort and discomfort (Mdoloris Medical Systems ®) for the parent.', 'timeFrame': 'Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.', 'description': 'ANI (analgesia nociception index) : evaluate an index of continuous analgesia during the skin-to-skin session.\n\nANI is physiologically above 60%. The threshold of discomfort in the newborn would correspond to a value \\<60.'}, {'measure': 'gestational age', 'timeFrame': 'at the inclusion'}, {'measure': 'Ptot (indices of variability of heart rate) for the parent', 'timeFrame': 'Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.', 'description': 'Measured during the ECG recording'}, {'measure': 'Ptot (indices of variability of heart rate) for the newborn', 'timeFrame': 'Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.', 'description': 'Measured during the ECG recording'}, {'measure': 'VLF (indices of variability of heart rate) for the parent', 'timeFrame': 'Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.', 'description': 'Measured during the ECG recording'}, {'measure': 'VLF (indices of variability of heart rate) for the newborn', 'timeFrame': 'Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.', 'description': 'Measured during the ECG recording'}, {'measure': 'LF (indices of variability of heart rate) for the parent', 'timeFrame': 'Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.', 'description': 'Measured during the ECG recording'}, {'measure': 'LF (indices of variability of heart rate) for the newborn', 'timeFrame': 'Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.', 'description': 'Measured during the ECG recording'}, {'measure': 'HF (indices of variability of heart rate) for the parent', 'timeFrame': 'Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.', 'description': 'Measured during the ECG recording'}, {'measure': 'HF (indices of variability of heart rate) for the newborn', 'timeFrame': 'Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.', 'description': 'Measured during the ECG recording'}, {'measure': 'ratio LF/HF (indices of variability of heart rate) for the parent', 'timeFrame': 'Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.', 'description': 'Measured during the ECG recording'}, {'measure': 'ratio LF/HF (indices of variability of heart rate) for the newborn', 'timeFrame': 'Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.', 'description': 'Measured during the ECG recording'}, {'measure': 'SDNN (indices of variability of heart rate) for the parent', 'timeFrame': 'Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.', 'description': 'Measured during the ECG recording'}, {'measure': 'SDNN (indices of variability of heart rate) for the newborn', 'timeFrame': 'Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.', 'description': 'Measured during the ECG recording'}, {'measure': 'SDANN (indices of variability of heart rate) for the parent', 'timeFrame': 'Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.', 'description': 'Measured during the ECG recording'}, {'measure': 'SDANN (indices of variability of heart rate) for the newborn', 'timeFrame': 'Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.', 'description': 'Measured during the ECG recording'}, {'measure': 'pNN30 and pNN50 (indices of variability of heart rate) for the parent', 'timeFrame': 'Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.', 'description': 'Measured during the ECG recording'}, {'measure': 'pNN30 and pNN50 (indices of variability of heart rate) for the newborn', 'timeFrame': 'Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.', 'description': 'Measured during the ECG recording'}, {'measure': 'RMSSD (indices of variability of heart rate) for the parent', 'timeFrame': 'Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.', 'description': 'Measured during the ECG recording'}, {'measure': 'RMSSD (indices of variability of heart rate) for the newborn', 'timeFrame': 'Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.', 'description': 'Measured during the ECG recording'}, {'measure': 'SD1 and SD2 (indices of variability of heart rate) for the parent', 'timeFrame': 'Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.', 'description': 'Measured during the ECG recording'}, {'measure': 'SD1 and SD2 (indices of variability of heart rate) for the newborn', 'timeFrame': 'Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.', 'description': 'Measured during the ECG recording'}, {'measure': 'Poincaré-plot index (indices of variability of heart rate) for the parent', 'timeFrame': 'Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.', 'description': 'Measured during the ECG recording'}, {'measure': 'Poincaré-plot index (indices of variability of heart rate) for the newborn', 'timeFrame': 'Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.', 'description': 'Measured during the ECG recording'}, {'measure': 'fractal index (indices of variability of heart rate) for the parent', 'timeFrame': 'Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.', 'description': 'Measured during the ECG recording'}, {'measure': 'fractal index (indices of variability of heart rate) for the newborn', 'timeFrame': 'Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.', 'description': 'Measured during the ECG recording'}, {'measure': 'entropy index (indices of variability of heart rate) for the parent', 'timeFrame': 'Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.', 'description': 'Measured during the ECG recording'}, {'measure': 'entropy index (indices of variability of heart rate) for the newborn', 'timeFrame': 'Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.', 'description': 'Measured during the ECG recording'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['kangaroo care', 'neonatal intensive care units', 'autonomic co-regulation'], 'conditions': ['Newborn']}, 'descriptionModule': {'briefSummary': "Mother-infant separation, as a result of hospitalization, leads to stress and anxiety for both parent and infant, lowers feelings of maternal competency and corrupts bonding process.\n\nKangaroo Care (KC), is as a widespread procedure in which the naked newborn is placed on the parent's bare chest. KC is known to enhance neonatal outcome by improving temperature regulation, cardiorespiratory stability or psychomotor development. It also promotes mother-infant interactions and enhances parental psychological well-being.\n\nHeart rate variability (HRV) analysis is a non-invasive tool able to consider autonomic nervous system activity. Previous studies have shown that pleasant feelings are associated with an increase of high frequencies variations index (HFnu index) reflecting a prevalence of parasympathetic activity. This one can be assess by a new monitor called NIPΣ (Neonatal index of parasympathetic activity) in newborns and ANI (Analgesic nociception index) in adults can provide a comfort index by quantifying the parasympathetic tone.\n\nThe investigators hypothesize that kangaroo care could induce an autonomic co-regulation between newborn and parent by increasing parasympathetic activity.\n\nThe study will involve 40 preterm or term newborns and their parent, performing a one hour kangaroo care session in intensive unit and neonatal intensive care unit from hospital of Saint-Etienne (France)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '3 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria for the newborn :\n\n* Neonates over 28 weeks of gestational age, under 3 months, hospitalized in neonatal intensive care units of the university hospital of Saint-Etienne (France),\n* performing a one hour (or more) kangaroo care session with his parent.\n\nInclusion Criteria for the parent (father or mother) :\n\n\\- To be a parent of a child eligible for the research protocol,\n\nExclusion Criteria for the newborn :\n\n* Newborn sedated\n* Newborn with a treatment known to alter the sympathetic or parasympathetic activity of the autonomic nervous system.\n* Associated and severe brain pathology\n* Anoxo-ischemic encephalopathy\n* Unbalanced congenital heart disease,\n\nExclusion Criteria for the parents :\n\n* Parent with a treatment known to alter the sympathetic or parasympathetic activity of the autonomic nervous system.\n* Heart surgery or cardiac pathology\n* History of psychiatric pathology'}, 'identificationModule': {'nctId': 'NCT03690804', 'acronym': 'Co-PAP', 'briefTitle': 'Assessment of Autonomic Co-regulation Between Newborn and Parent During Kangaroo Care Sessions in Neonatal Intensive Care Units', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Saint Etienne'}, 'officialTitle': 'Assessment of Autonomic Co-regulation Between Newborn and Parent During Kangaroo Care Sessions in Neonatal Intensive Care Units', 'orgStudyIdInfo': {'id': '18CH048'}, 'secondaryIdInfos': [{'id': '2018-A00765-50', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'newborn is above 28 weeks of gestational age', 'description': '40 parent-newborn duos in which the newborn is above 28 weeks of gestational age and less than 3 months of life and hospitalized in neonatal intensive care units of our university hospital (Saint-Etienne - France)', 'interventionNames': ['Device: Evaluation of Autonomic nervous system indices']}], 'interventions': [{'name': 'Evaluation of Autonomic nervous system indices', 'type': 'DEVICE', 'description': 'The ECG signal, respiration rate, SpO2 and NIPΣ or ANI are recorded simultaneously on a computer with a capture card. The other indices of HRV will be analyzed offline: SDNN (standard deviation of all NN intervals), pNN30 (NN30 count divided by the total number of all NN intervals), pNN50 (NN50 count divided by the total number of all NN intervals), RMSSD (quadratic mean of successive R-R intervals), SD1 (standard deviation), SD2 (standard deviation), LF (low frequencies), HF (high frequencies), VLF (very low frequencies), SDANN (standard deviation of the averages of NN intervals in all 5 min segments of the entire recording), ratio LF/ HF, Ptot, Poincaré plot (plot points corresponding to each R-R space of a record).', 'armGroupLabels': ['newborn is above 28 weeks of gestational age']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42055', 'city': 'Saint-Etienne', 'country': 'France', 'facility': 'CHU de Saint Etienne', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}], 'overallOfficials': [{'name': 'Hugues PATURAL, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU de Saint Etienne'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Saint Etienne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}