Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2026-01-01 @ 9:20 AM
Study NCT ID:
NCT01684618
Status:
COMPLETED
Last Update Posted:
2013-11-08
First Post:
2012-09-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neonatal Cerebral Oxygenation and Changes in CPAP Flow Pressure - Evaluation With INVOS Oximeter
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-06', 'studyFirstSubmitDate': '2012-09-11', 'studyFirstSubmitQcDate': '2012-09-11', 'lastUpdatePostDateStruct': {'date': '2013-11-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-09-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in regional cerebral oxygen saturation, rSO2, during induced changes in CPAP flow pressure', 'timeFrame': 'Measurements will take between 30 minutes and 3 hours depending of situation. Within the first 4 weeks of life.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Preterm', 'Neonate', 'Newborn', 'Cerebral oxygenation', 'CPAP'], 'conditions': ['Cerebral Oxygenation']}, 'descriptionModule': {'briefSummary': '* Due to the increased risk of brain damage, continuous monitoring of the cerebral oxygenation is interesting. We will evaluate the capability of the INVOS Oximeter to detect induced changes in the cerebral regional saturation.\n* The purpose of the study is to investigate our hypothesis that a particular CPAP flow pressure optimizes the regional cerebral oxygenation.', 'detailedDescription': 'Preterm infants are at increased risk of brain damage compared with term infants, and cerebral hypoxia is considered to have an important role. The preterm infants are at increased risk of respiratory distress, episodes with low oxygenation, mechanical ventilation, risk of hypocapnia and labile or low blood pressure. These conditions can affect the microcirculation and hence the oxygenation of the brain. Hyperoxia is also a point of interest, since high levels of oxygen can cause vasoconstriction. Preterm infants is often treated with CPAP (Continuous positive airway pressure), but the effect of different flow pressures on the regional cerebral oxygenation is not known.\n\nThe investigators will examine the normal physiological response of the brain in a group of preterm infants with a gestational age (GA) of 32-37 weeks and a group of term infants to the commonly used treatment in neonatology, CPAP (Continuous positive airway pressure).\n\nThe investigators will do dynamic research with continuously monitoring of the cerebral oxygenation using the INVOS® Cerebral/Somatic Oximeter (Near InfraRed Spectroscopy (NIRS)). INVOS® is the first NIRS-based oximeter CE-approved for hospital use in Denmark.\n\nThere will be no follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '4 Weeks', 'minimumAge': '1 Hour', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inclusion Criteria: - Newborns with a gestational age of 32-40 weeks - Clinically stable - +/- CPAP with a oxygen limit below 30% - Parental consent\n\nExclusion Criteria:\n\n* Severe birth asphyxia - Prohibition of oxygen exposure'}, 'identificationModule': {'nctId': 'NCT01684618', 'briefTitle': 'Neonatal Cerebral Oxygenation and Changes in CPAP Flow Pressure - Evaluation With INVOS Oximeter', 'organization': {'class': 'OTHER', 'fullName': 'Copenhagen University Hospital, Hvidovre'}, 'officialTitle': 'Oxygenation of the Neonatal Brain - a Study Using the INVOS Oximeter', 'orgStudyIdInfo': {'id': 'CPAP - HH 527'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cerebral NIRS oximetry + CPAP', 'description': 'Cerebral NIRS oximetry, using the INVOS Cerebral/Somatic Oximeter, and changes in regional cerebral oxygen saturation, rSO2, during induced changes in CPAP flow pressure', 'interventionNames': ['Procedure: Cerebral NIRS Oximetry + CPAP']}], 'interventions': [{'name': 'Cerebral NIRS Oximetry + CPAP', 'type': 'PROCEDURE', 'otherNames': ['INVOS 5100C Oximeter'], 'description': 'CPAP flow pressure is increased for 5 minutes then 15 minutes with CPAP pressure at baseline. Repeated once', 'armGroupLabels': ['Cerebral NIRS oximetry + CPAP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2650', 'city': 'Hvidovre', 'country': 'Denmark', 'facility': 'Department of Paediatrics, Copenhagen University Hospital; Hvidovre', 'geoPoint': {'lat': 55.64297, 'lon': 12.47708}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Copenhagen University Hospital, Hvidovre', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Ludvig & Sara Elsass Foundation', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PH.D.', 'investigatorFullName': 'Line Carøe Sørensen', 'investigatorAffiliation': 'Copenhagen University Hospital, Hvidovre'}}}}