Ignite Creation Date:
2025-12-25 @ 3:40 AM
Ignite Modification Date:
2025-12-26 @ 2:24 AM
Study NCT ID:
NCT00850902
Status:
UNKNOWN
Last Update Posted:
2009-03-10
First Post:
2009-02-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Humidity Strategy to Decrease Morbidity and Mortality in Extremely Low Birth Weight Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 700}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-03', 'completionDateStruct': {'date': '2010-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-03-09', 'studyFirstSubmitDate': '2009-02-23', 'studyFirstSubmitQcDate': '2009-02-24', 'lastUpdatePostDateStruct': {'date': '2009-03-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-02-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Death prior to discharge or Bronchopulmonary Dysplasia (BPD) defined as oxygen requirement at 36 weeks postmenstrual age.', 'timeFrame': '36 weeks postmenstrual age'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['ELBW', 'Humidity', 'BPD'], 'conditions': ['Extremely Low Birth Weight']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to apply a different incubator humidity strategy at birth to decrease morbidity and mortality in extremely low birth (1000 g or less) infants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inborn Premature Infants with weight ≤ 1000 g at birth\n\nExclusion Criteria:\n\n* Outborn infants.\n* Failure to obtain parental consent for the study.\n* Congenital malformations likely to affect life expectancy or neurosensory development.\n* Unlikely to be available for follow up.'}, 'identificationModule': {'nctId': 'NCT00850902', 'briefTitle': 'Humidity Strategy to Decrease Morbidity and Mortality in Extremely Low Birth Weight Infants', 'organization': {'class': 'OTHER_GOV', 'fullName': 'King Fahad Medical City'}, 'officialTitle': 'Application of a Different Incubator Humidity Strategy at Birth to Decrease Morbidity and Mortality in Extremely Low Birth (1000 g or Less) Infants', 'orgStudyIdInfo': {'id': '08-049'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Moderate Humidity (MH)', 'interventionNames': ['Other: Moderate Humidity']}, {'type': 'EXPERIMENTAL', 'label': 'High Humidity', 'interventionNames': ['Other: High Humidity (HH)']}], 'interventions': [{'name': 'High Humidity (HH)', 'type': 'OTHER', 'description': 'High Humidity Level', 'armGroupLabels': ['High Humidity']}, {'name': 'Moderate Humidity', 'type': 'OTHER', 'description': 'Moderate Humidity Level', 'armGroupLabels': ['Moderate Humidity (MH)']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Jasim Anabrees', 'role': 'CONTACT', 'email': 'jasim1800@yahoo.com', 'phone': '+966 590 591 102'}], 'overallOfficials': [{'name': 'Jasim Anabrees', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'King Fahad Medical City'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'King Fahad Medical City', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': 'Jasim Anabrees', 'oldOrganization': 'King Fahad Medical City'}}}}