Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-26 @ 2:08 AM
Study NCT ID:
NCT00306605
Status:
COMPLETED
Last Update Posted:
2017-06-21
First Post:
2006-03-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Emotional Experiences in Fathers of NICU Infants
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-19', 'studyFirstSubmitDate': '2006-03-22', 'studyFirstSubmitQcDate': '2006-03-23', 'lastUpdatePostDateStruct': {'date': '2017-06-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-03-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Perceived paternal stress levels will be lower for those fathers of infants who are hospitalized in a medical NICU compared with fathers of infants who are hospitalized in a surgical NICU.', 'timeFrame': "First 5 weeks of infant's life and / or hospitalization"}], 'secondaryOutcomes': [{'measure': 'Stress levels for fathers of hospitalized infants will decrease over time.', 'timeFrame': "Within the first 5 weeks of their infant's birth / hospitalization"}, {'measure': 'Depressive symptomatology modulates perceived stress in fathers of infants in NICUs.', 'timeFrame': "First 5 weeks after their infant's birth / hospitalization"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Emotional experiences', 'fathers', 'stress', 'depressive symptomatology', 'NICU', 'preterm birth'], 'conditions': ['Stress', 'Depressive Symptomatology']}, 'referencesModule': {'references': [{'pmid': '14502526', 'type': 'BACKGROUND', 'citation': 'Miles MS, Brunssen SH. Psychometric properties of the parental stressor scale: infant hospitalization. Adv Neonatal Care. 2003 Aug;3(4):189-96. doi: 10.1016/s1536-0903(03)00138-3.'}]}, 'descriptionModule': {'briefSummary': 'This study is designed to evaluate the emotional experiences of fathers who have preterm infants who are hospitalized in a (neonatal intensive care unit)NICU setting. In addition, we will compare the emotional responses experienced by father of surgical NICU babies and fathers of medical NICU babies.\n\nOur primary hypothesis is that paternal stress levels will be lower for those fathers of infants who are hospitalized in a medical NICU compared with fathers of infants who are hospitalized in a surgical NICU.\n\nSecondary hypotheses include: 1) Stress levels for fathers of hospitalized infants will decrease over time; 2) Depressive symptomatology modulates perceived stress in fathers of NICU infants.', 'detailedDescription': "It is well known that birth and hospitalization of a preterm infant is stressful for parents. Numerous studies have evaluated emotional factors such as maternal stress, parental role alteration, and maternal depression. Researchers have also investigated both maternal and paternal emotional responses in relation to their infant being hospitalized in the NICU. Studies examining paternal response alone have received less research attention. To date, no studies have compared the emotional response of fathers of medical NICU babies and fathers of surgical NICU babies.\n\nThe purpose of this study is to evaluate and compare perceived paternal stress and depressive symptomatology in fathers of preterm medical and surgical infants. Fathers who agree to participate will be given a questionnaire that is comprised of two self-report tools. Together these tools should take approximately 15-20 minutes to complete. Fathers who participate will be asked to complete these tools at three different times throughout their infants' stay in the NICU."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Fathers of preterm infants who are hospitalized in a newborn intensive care unit.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* consenting fathers who are English speaking\n* fathers with preterm infants \\< 30 weeks gestation and who are likely to survive\n* Infants who lack congenital or genetic abnormalities likely to be associated with significant neurodevelopmental handicaps.\n\nExclusion Criteria:\n\n* There are no specific exclusion criteria.'}, 'identificationModule': {'nctId': 'NCT00306605', 'briefTitle': 'Emotional Experiences in Fathers of NICU Infants', 'organization': {'class': 'OTHER', 'fullName': 'Christiana Care Health Services'}, 'officialTitle': 'Emotional Experiences in Fathers of NICU Babies: A Comparison of Fathers in Medical and Surgical NICUs.', 'orgStudyIdInfo': {'id': '26047'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Questionnaire', 'type': 'BEHAVIORAL', 'description': "Participants will be asked to complete a questionnaire 3 times throughout the first 5 weeks after their infant's birth / hospitalization"}]}, 'contactsLocationsModule': {'locations': [{'zip': '19718', 'city': 'Newark', 'state': 'Delaware', 'country': 'United States', 'facility': 'Christiana Hospital (Christiana Care Health Systems)', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}, {'zip': '19899', 'city': 'Wilmington', 'state': 'Delaware', 'country': 'United States', 'facility': 'A.I. duPont Hospital for Children', 'geoPoint': {'lat': 39.74595, 'lon': -75.54659}}], 'overallOfficials': [{'name': 'Amy B. Mackley, MSN, RNC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Christiana Care Health Systems'}, {'name': 'Michael L. Spear, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Christiana Care Health Systems; A.I. duPont Hospital for Children'}, {'name': 'Robert G. Locke, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Christiana Care Health Systems; A.I. duPont Hospital for Children'}, {'name': 'Rachel Joseph, MSN, CCRN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Alfred I. duPont Hospital for Children'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Christiana Care Health Services', 'class': 'OTHER'}, 'collaborators': [{'name': 'Alfred I. duPont Hospital for Children', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Amy Mackley', 'investigatorFullName': 'Amy Mackley', 'investigatorAffiliation': 'Christiana Care Health Services'}}}}