Ignite Creation Date:
2025-12-24 @ 7:04 PM
Ignite Modification Date:
2026-01-02 @ 10:49 AM
Study NCT ID:
NCT00565357
Status:
COMPLETED
Last Update Posted:
2007-11-29
First Post:
2007-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Silicone Earplugs for VLBW Newborns in Intensive Care
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': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-11', 'completionDateStruct': {'date': '2005-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-11-27', 'studyFirstSubmitDate': '2007-11-27', 'studyFirstSubmitQcDate': '2007-11-27', 'lastUpdatePostDateStruct': {'date': '2007-11-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-11-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weight', 'timeFrame': '34 weeks post-menstrual age'}], 'secondaryOutcomes': [{'measure': 'Length of stay in neonatal intensive care', 'timeFrame': 'hospital discharge'}, {'measure': 'Time on mechanical ventilator', 'timeFrame': 'hospital discharge'}, {'measure': 'Weight', 'timeFrame': '18 - 22 months of age'}, {'measure': 'Length', 'timeFrame': '18 - 22 months of age'}, {'measure': 'Frontal-occipital circumference', 'timeFrame': '18 - 22 months of age'}, {'measure': 'Bayley Mental Developmental Index', 'timeFrame': '18 - 22 months of age'}, {'measure': 'Bayley Psychomotor Developmental Index', 'timeFrame': '18 - 22 months of age'}, {'measure': 'ABR Hearing Screen', 'timeFrame': 'hospital discharge'}]}, 'conditionsModule': {'keywords': ['Postnatal Growth', 'Postnatal Development', 'Noise', 'Neonatal Intensive Care Unit'], 'conditions': ['Postnatal Growth']}, 'referencesModule': {'references': [{'pmid': '19194455', 'type': 'DERIVED', 'citation': 'Abou Turk C, Williams AL, Lasky RE. A randomized clinical trial evaluating silicone earplugs for very low birth weight newborns in intensive care. J Perinatol. 2009 May;29(5):358-63. doi: 10.1038/jp.2008.236. Epub 2009 Feb 5.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to determine the effects of individual noise reduction using silicone earplugs for very low birthweight newborns in neonatal intensive care on growth and development. The study hypothesis was that newborns who were randomized to the earplug group would be heavier than controls at 34 weeks post-menstrual age.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Days', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* birthweight between 401 and 1500 grams\n* less than 1 week of age\n* parental informed consent\n* availability of research personnel\n\nExclusion Criteria:\n\n* terminal illness\n* congenital anomalies\n* syndromes associated with hearing loss'}, 'identificationModule': {'nctId': 'NCT00565357', 'briefTitle': 'Silicone Earplugs for VLBW Newborns in Intensive Care', 'organization': {'class': 'NIH', 'fullName': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)'}, 'officialTitle': 'Silicone Earplugs for VLBW Newborns in Intensive Care: Feasibility, Sound Attenuation, and Outcomes From a Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'R01HD042639-01A3', 'link': 'https://reporter.nih.gov/quickSearch/R01HD042639-01A3', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'E', 'interventionNames': ['Device: Silicone Earplugs']}, {'type': 'NO_INTERVENTION', 'label': 'C', 'interventionNames': ['Other: Control']}], 'interventions': [{'name': 'Silicone Earplugs', 'type': 'DEVICE', 'description': 'Silicone earplugs worn from within 1 week of birth through 35 weeks post-menstrual age or hospital discharge, whichever came first', 'armGroupLabels': ['E']}, {'name': 'Control', 'type': 'OTHER', 'description': 'Standard care in the neonatal intensive care unit', 'armGroupLabels': ['C']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Robert E Lasky, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas Medical School at Houston'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}}}}