Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-26 @ 1:03 AM
Study NCT ID:
NCT04849234
Status:
COMPLETED
Last Update Posted:
2022-12-27
First Post:
2021-04-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Acoustic Analysis of the First Babies Crying in Delivery Room and Adaptation to Extra Uterine Life
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}, {'id': 'D003448', 'term': 'Crying'}, {'id': 'D018730', 'term': 'Infant Behavior'}], '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': 'D009633', 'term': 'Nonverbal Communication'}, {'id': 'D003142', 'term': 'Communication'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D002652', 'term': 'Child Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2021-05-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-23', 'studyFirstSubmitDate': '2021-04-13', 'studyFirstSubmitQcDate': '2021-04-13', 'lastUpdatePostDateStruct': {'date': '2022-12-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fo : maximum fundamental frequency (Hz) of the cry', 'timeFrame': 'During the first 15 minutes of life', 'description': 'Measured by device: Recorder ZOOM H4N and analyzed with PRAAT® software\n\nThe F0 and Apgar score will be correlated'}, {'measure': 'Apgar score (0-10)', 'timeFrame': 'During the first 15 minutes of life', 'description': 'The Apgar score is determined by evaluating the newborn baby on five simple criteria on a scale from zero to two, then summing up the five values thus obtained. The resulting score ranges from zero to 10.\n\nThe five criteria are : appearance, pulse, grimace, activity, respiration.\n\nThe F0 and Apgar score will be correlated'}], 'secondaryOutcomes': [{'measure': 'Pitch of the cry (Hz) Crying acoustic structures', 'timeFrame': 'During the first 15 minutes of life', 'description': 'Measured by device: Recorder ZOOM H4N and analyzed with PRAAT® software'}, {'measure': 'roughness of the cry (Hz)', 'timeFrame': 'During the first 15 minutes of life', 'description': 'Measured by device: Recorder ZOOM H4N and analyzed with PRAAT® software'}, {'measure': 'Duration of cry (s)', 'timeFrame': 'During the first 15 minutes of life', 'description': 'Measured by device: Recorder ZOOM H4N and analyzed with PRAAT® software'}, {'measure': 'Number of cry', 'timeFrame': 'During the first 15 minutes of life', 'description': 'Measured by device: Recorder ZOOM H4N and analyzed with PRAAT® software'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Crying', 'Apgar score', 'Infant Behavior', 'First cry', 'delivery room', 'extra uterine life'], 'conditions': ['Premature Birth']}, 'descriptionModule': {'briefSummary': "Interpreting the cry of new-borns is a real challenge not only for perinatal professionals but also for parents, who are confronted daily with those sounds.\n\nThe description and the acoustic analysis of baby's cry can allow healthcare professionals to better adapt their care during the first months of life.\n\nThanks to an objective analysis method as acoustic analysis, the particularities of the first cry should provide us information on the quality of adaptation to ambient air life.", 'detailedDescription': "Interpreting the cry of new-borns is a real challenge not only for perinatal professionals but also for parents, who are confronted daily with those sounds.\n\nThe description and the acoustic analysis of baby's cry can allow healthcare professionals to better adapt their care during the first months of life. Aiming for this objective, many studies have already been carried out on infants crying in the first months of life, in order to better understand their significance (pain, discomfort, hunger) and the mechanisms of recognition and discrimination by parents or listeners. Various techniques are promising to characterize the acoustic space of cry (maximum frequency, intensity, harmonics, duration…).\n\nHowever, few studies have investigated the acoustic characteristics of the first cry of life in the delivery room. Its intensity and characteristics are closely related to the laryngeal anatomy and respiratory capacity. Thus, a vigorous cry with its own acoustic characteristics could be the witness of a good adaptation to extra uterine life, while a weak or plaintive cry should warn the caregiver on difficulties in this adaptation.\n\nThanks to an objective analysis method as acoustic analysis, the particularities of the first cry should provide us information on the quality of adaptation to ambient air life.\n\nThe investigators hypothesize that the acoustic characteristics of the first cries of newborns recorded at birth are correlated with the criteria of extra uterine life adaptation (Apgar score, pH and lactates collected from the umbilical cord), with the respiratory score (Silverman) and with the early neonatal outcome (transfer to the intensive care unit)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Minutes', 'minimumAge': '1 Minute', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Infant newborn', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infant born between 37 and 42 SA\n* Live infant at birth\n* Parent who received informed written information about the study\n\nExclusion Criteria:\n\n\\- Emergency after childbirth (haemorrhage)'}, 'identificationModule': {'nctId': 'NCT04849234', 'acronym': 'FIRSTCRY', 'briefTitle': 'Acoustic Analysis of the First Babies Crying in Delivery Room and Adaptation to Extra Uterine Life', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Saint Etienne'}, 'officialTitle': 'FirstCRY Study : Acoustic Analysis of the First Babies Crying in Delivery Room and Adaptation to Extra Uterine Life', 'orgStudyIdInfo': {'id': 'IRBN262021/CHUSTE'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'New born', 'description': 'New born population aged 37 Weeks of Amenorrhea (SA) to 42 Weeks of Amenorrhea (SA) will be included. Their cries will be longitudinally registered.', 'interventionNames': ['Behavioral: newborn cries']}], 'interventions': [{'name': 'newborn cries', 'type': 'BEHAVIORAL', 'description': 'Their cries will be longitudinally registered from the age of birth until the first 15 minutes of birth using an automatic record device: Recorder ZOOM H4N.\n\nThe wav-sized files obtained from each recording will then be analyzed indiscriminately via an acoustic processing script created for the PRAAT software® by the post-doctoral fellows of the ENES laboratory (Sensory NeuroEthology Team) on the site of the Faculty of Sciences of Saint-Etienne.', 'armGroupLabels': ['New born']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Saint-Etienne', 'country': 'France', 'facility': 'Chu Saint-Etienne', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}], 'overallOfficials': [{'name': 'HUGUES PATURAL, MD PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU ST ETIENNE FRANCE'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Saint Etienne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}