Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2026-03-22 @ 5:50 AM
Study NCT ID:
NCT02496104
Status:
RECRUITING
Last Update Posted:
2025-09-16
First Post:
2015-07-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Habituation's Mechanisms in Preterm and Term Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013016', 'term': 'Sound'}], 'ancestors': [{'id': 'D011840', 'term': 'Radiation, Nonionizing'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D055585', 'term': 'Physical Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-07-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2029-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-10', 'studyFirstSubmitDate': '2015-07-09', 'studyFirstSubmitQcDate': '2015-07-13', 'lastUpdatePostDateStruct': {'date': '2025-09-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-07-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Assessment of the package n°1 of the APIB (Assessment of Premature Infant's Behaviour)", 'timeFrame': 'At 40 weeks of postnatal gestational age for the preterm infants and at 3 days old for the term newborns'}], 'secondaryOutcomes': [{'measure': 'Salivary cortisol changes', 'timeFrame': 'Before and 30 minutes after the package n°1 of the APIB achievement'}, {'measure': 'Oxy and deoxyhemoglobin changes in NIRS (Near-infrared Spectroscopy)', 'timeFrame': 'During APIB package n°1 fulfillment'}, {'measure': 'Heart rate variations', 'timeFrame': 'During APIB package n°1 fulfillment'}, {'measure': 'Oxymetry variations', 'timeFrame': 'During APIB package n°1 fulfillment'}, {'measure': 'Brief Infant Sleep Questionnaire', 'timeFrame': 'At 6 and 12 months old (corrected age for the preterm infants)'}, {'measure': 'Ages and Stages Questionnaire', 'timeFrame': 'At 24 months old (corrected age for the preterm infants)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Preterm', 'Infant', 'Habituation', 'APIB'], 'conditions': ['Habituation, Psychophysiological', 'Preterm, Infant']}, 'descriptionModule': {'briefSummary': 'Each year in France, 7 % of newborns are born preterm (before 37 weeks of gestational age (GA)). The investigators called very preterm infants those who were born before 33 weeks of GA. These very preterm infants have a higher risk of developing neurological complications like developmental disabilities or cerebral palsy. To date, early assessment of these infants is difficult and not reliable enough to detect those who are at risks of developing neurological issues. Now, the investigators need to identify earlier these infants to provide them interventions to improve their development (physical therapy for example). Consequently, the investigators are examining a study whose aim is to assess preterm infants habituation. Habituation is the newborn ability to become familiar with new environmental stimulations (noise, light…). This habituation allows the newborn to maintain his sleep even at onset of a noise or light. To study this phenomenon in infants born preterm near to corrected term (around 40 weeks of postnatal GA), will allow us to better understand neurological development of these infants. The investigators plan to compare habituation skills of preterm infants near to their theorical date of birth (40 weeks of GA) to a population of infants born at term. The investigators will also study the link between habituation abilities and sleep quality as well as neurodevelopmental outcome at the corrected age of two years old.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Weeks', 'minimumAge': '2 Days', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Preterm infants and term infants born in Brest University Hospital', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Preterm infants: preterm infants born from 25 weeks to 32 weeks + 6 days of gestation near to 36 weeks of gestation (corrected postnatal age)\n* Term infants: term newborns with a gestational age between 39 and 41 weeks of gestation at day 3 with an Apgar ≥ 1 at 1 minute of life\n* For both groups: normal neurological physical examination, written informed consent of the parents\n\nExclusion Criteria:\n\n* no malformation or chromosomal abnormality, life threatening disease, administration of morphine or sedatives during the 24 hours before the study, context of maternal drug addiction, deafness, no psychoactive drug or anticonvulsivants during the last month of pregnancy for the term newborns, severe neurological disease'}, 'identificationModule': {'nctId': 'NCT02496104', 'acronym': 'HABIPREMA', 'briefTitle': "Habituation's Mechanisms in Preterm and Term Infants", 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Brest'}, 'officialTitle': "Habituation's Mechanisms in Preterm and Term Infants. Behavioral Evaluation: APIB (Assessment of Preterm Infant's Behavior). Assessment of the Cortical and Vegetative Responses", 'orgStudyIdInfo': {'id': '29BRC14.0059'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Preterm infants', 'description': 'Preterm infants born between 25 weeks and 32 weeks + 6 days of gestation', 'interventionNames': ['Behavioral: Package n°1 of the APIB']}, {'label': 'Term newborns', 'description': 'Infant born at term', 'interventionNames': ['Behavioral: Package n°1 of the APIB']}], 'interventions': [{'name': 'Package n°1 of the APIB', 'type': 'BEHAVIORAL', 'otherNames': ['Sound and light stimulations'], 'armGroupLabels': ['Preterm infants', 'Term newborns']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29609', 'city': 'Brest', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jean-Michel ROUE, Professor', 'role': 'CONTACT', 'email': 'jean-michel.roue@chu-brest.fr'}], 'facility': 'CHRU de Brest', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}], 'centralContacts': [{'name': 'Jean-Michel ROUE, Professor', 'role': 'CONTACT', 'email': 'jean-michel.roue@chu-brest.fr'}], 'overallOfficials': [{'name': 'Jean-Michel ROUE, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHRU de Brest'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Brest', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}