Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2026-01-23 @ 3:33 PM
Study NCT ID:
NCT02885051
Status:
TERMINATED
Last Update Posted:
2025-12-12
First Post:
2016-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Pain in Preterm Newborn
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 91}}, 'statusModule': {'whyStopped': 'At the end of the inclusion period, the observed correlations were much lower than expected. Thus, it did not seem relevant to prolong the inclusions.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-01-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2018-01-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-05', 'studyFirstSubmitDate': '2016-08-26', 'studyFirstSubmitQcDate': '2016-08-30', 'lastUpdatePostDateStruct': {'date': '2025-12-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-08-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-01-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation between HFVI index and PIPP-R pain score .', 'timeFrame': "12 months plus the total duration of the patient's hospitalization", 'description': 'In case of repeated measurements on the same child, only the first couple of steps will be considered for this correlation calculation.'}], 'secondaryOutcomes': [{'measure': 'Correlation between skin conductance and pain score PIPP-R.', 'timeFrame': "12 months plus the total duration of the patient's hospitalization", 'description': 'In case of repeated measurements on the same child, only the first couple of steps will be considered for this correlation calculation.'}, {'measure': 'Correlation between skin conductance, HFVI and PIPP-R according to the type of painful procedure: painful or not', 'timeFrame': "12 months plus the total duration of the patient's hospitalization", 'description': 'This correlation will be measured'}, {'measure': 'Correlation of cutaneous conductance, HFVI and PIPP-R according to the gestational age group type', 'timeFrame': "12 months plus the total duration of the patient's hospitalization", 'description': 'This correlation will be measured'}, {'measure': 'Correlation of cutaneous conductance, HFVI and PIPP-R according to the sex of the child', 'timeFrame': "12 months plus the total duration of the patient's hospitalization", 'description': 'This correlation will be measured'}, {'measure': 'Caregiver satisfaction with each technique via the likert scale.', 'timeFrame': "12 months plus the total duration of the patient's hospitalization", 'description': 'The score will be measured'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain', 'Preterm Newborn']}, 'referencesModule': {'references': [{'pmid': '32961546', 'type': 'RESULT', 'citation': 'Gendras J, Lavenant P, Sicard-Cras I, Consigny M, Misery L, Anand KJS, Sizun J, Roue JM. The newborn infant parasympathetic evaluation index for acute procedural pain assessment in preterm infants. Pediatr Res. 2021 May;89(7):1840-1847. doi: 10.1038/s41390-020-01152-4. Epub 2020 Sep 22.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to correlate the composite PIPP-R (Premature Infant Pain Profile-Revised) scale and the parasympathetic nervous system (heart rate variability).', 'detailedDescription': 'The premature newborns hospitalized for several weeks are exposed to a significant number of nursing procedures or painful or stressful medical. Repeated pain in the neonatal period may have negative consequences in the short and / or long term. The diagnosis of pain remains difficult because based on the hetero-assessment involving the use of validated scales. The PIPP-R scale (Premature Infant Pain Profile-Revised) appears to be the most complete and best validated scale as composite (behavior items, vegetative and contextual). However, it is rarely used in routine care in France.\n\nAlternatives to clinical scoring the pain level were described, in particular the analysis of the variability of the heart rate \\[VHR\\] by HFVI index (High Frequency Variability Index) or skin conductance. The analysis of the spectral components of high frequencies or HFVI would be an indicator of parasympathetic activity. The HFVI was compared to the EDIN scale, purely behavioral level, proposed as chronic pain marker. Skin conductance would be a stress marker reflecting variations of the sympathetic system.\n\nThese techniques are currently marketed for routine use. However, these methods have been compared and the NIPE (Newborn Infant parasympathetic Evaluation), which assesses the HFVI index, was not compared to a validated scale procedural acute pain (such as PIPP-R).\n\nIt seems important, before disseminating these methods, explore the consistency of these techniques with each other and validated scales, and their acceptability by nurses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '2 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Newborns with gestational age less than 36 weeks\n* Hospitalization in neonatology unit or intensive care unit\n* Signature of major parental consent for participation of their child\n\nExclusion Criteria:\n\n* Brain injury (intraventricular haemorrhage\\> Grade 2 or peri- ventricular leukomalacia extended)\n* Administration of anticholinergic or adrenergic antagonist in the previous 48 hours\n* Administration of curares\n* Genetic abnormality or severe malformation'}, 'identificationModule': {'nctId': 'NCT02885051', 'acronym': 'TRIPAIN', 'briefTitle': 'Evaluation of Pain in Preterm Newborn', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Brest'}, 'officialTitle': 'Comparative Analysis of a Behavioral Level, Skin Conductance and Heart Rate Variability in Assessing the Pain in Preterm Newborn', 'orgStudyIdInfo': {'id': 'TRIPAIN RB 16.002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'preterm newborn', 'description': 'Newborns hospitalized in the neonatal or Neonatal Resuscitation unit of Brest University Hospital and born before 36 weeks of gestation who will have recording of skin conductance and heart rate variability.', 'interventionNames': ['Procedure: Recording of skin conductance and heart rate variability.']}], 'interventions': [{'name': 'Recording of skin conductance and heart rate variability.', 'type': 'PROCEDURE', 'description': 'When a procedure of care will be prescribed, installation of the electrodes of measure of the cutaneous conductance on the foot and connection of the NIPE monitor to the cardio-respiratory monitor of the child used in routine. At this stage, beginning of the video recording.', 'armGroupLabels': ['preterm newborn']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29609', 'city': 'Brest', 'country': 'France', 'facility': 'CHRU Brest', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}], 'overallOfficials': [{'name': 'Jean-Michel Roue, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHRU de Brest'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Data will be available after the publication of result and ending fifteen years following the last visit of the last patient', 'ipdSharing': 'YES', 'description': 'All collected data that underlie results in a publication', 'accessCriteria': 'Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Brest', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}