Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2026-03-04 @ 8:23 PM
Study NCT ID:
NCT02372266
Status:
COMPLETED
Last Update Posted:
2015-02-26
First Post:
2015-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Cost-Effectiveness of Early Maternal Newborn Infant Discharge
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': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2223}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1997-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2001-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-19', 'studyFirstSubmitDate': '2015-02-03', 'studyFirstSubmitQcDate': '2015-02-19', 'lastUpdatePostDateStruct': {'date': '2015-02-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-02-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2001-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Admission to the Level II/III neonatal care unit or hospital', 'timeFrame': '72 hours', 'description': 'All admissions to the Level II/III neonatal care unit following delivery'}], 'secondaryOutcomes': [{'measure': 'Emergency department visits, clinic visits, or hospital admissions', 'timeFrame': '72 hours', 'description': 'Any unplanned pediatric visit to an emergency room, clinic or a hospital admission'}, {'measure': 'Emergency department visits, clinic visits, or hospital admissions', 'timeFrame': '14 days', 'description': 'Any unplanned pediatric visit to an emergency room, clinic or a hospital admission'}, {'measure': 'Emergency department visits, clinic visits, or hospital admissions', 'timeFrame': '8 weeks', 'description': 'Any unplanned pediatric visit to an emergency room, clinic or a hospital admission'}, {'measure': 'Emergency department visits, clinic visits, or hospital admissions', 'timeFrame': '6 months', 'description': 'Any unplanned pediatric visit to an emergency room, clinic or a hospital admission'}, {'measure': 'Breastfeeding score (5 point Likert scale)', 'timeFrame': 'At discharge (12 to 72 hours after delivery)', 'description': '5 point Likert scale: Only breast, mostly breast, 50/50, mostly bottle, only bottle'}, {'measure': 'Breastfeeding score (5 point Likert scale)', 'timeFrame': '14 days', 'description': '5 point Likert scale: Only breast, mostly breast, 50/50, mostly bottle, only bottle'}, {'measure': 'Breastfeeding score (5 point Likert scale)', 'timeFrame': '8 weeks', 'description': '5 point Likert scale: Only breast, mostly breast, 50/50, mostly bottle, only bottle'}, {'measure': 'Breastfeeding score (5 point Likert scale)', 'timeFrame': '6 months', 'description': '5 point Likert scale: Only breast, mostly breast, 50/50, mostly bottle, only bottle'}, {'measure': 'Maternal anxiety (State/Trait Anxiety Inventory)', 'timeFrame': 'At discharge (12 to 72 hours after delivery)'}, {'measure': 'Maternal anxiety (State/Trait Anxiety Inventory)', 'timeFrame': '14 days', 'description': 'State/Trait Anxiety Inventory'}, {'measure': 'Maternal depression (Generalized Contentment Scale)', 'timeFrame': 'At discharge (12 to 72 hours after delivery)', 'description': 'Generalized Contentment Scale'}, {'measure': 'Maternal depression (Generalized Contentment Scale)', 'timeFrame': '14 days', 'description': 'Generalized Contentment Scale'}, {'measure': 'Maternal confidence (Confidence on a Likert scale)', 'timeFrame': 'At discharge (12 to 72 hours after delivery)', 'description': 'Confidence on a Likert scale'}, {'measure': 'Maternal confidence (Confidence on a Likert scale)', 'timeFrame': '14 days', 'description': 'Confidence on a Likert scale'}, {'measure': 'Maternal satisfaction with length of stay (Likert scale)', 'timeFrame': 'At discharge (12 to 72 hours after delivery)', 'description': 'Satisfaction with length of stay on a Likert scale'}, {'measure': 'Maternal satisfaction with length of stay (Likert scale)', 'timeFrame': '14 days', 'description': 'Satisfaction with length of stay on a Likert scale'}, {'measure': 'Maternal satisfaction with overall experience (Likert scale)', 'timeFrame': 'At discharge (12 to 72 hours after delivery)', 'description': 'Satisfaction with overall childbirth experience on a Likert scale'}, {'measure': 'Maternal satisfaction with overall experience (Likert scale)', 'timeFrame': '14 days', 'description': 'Satisfaction with overall childbirth experience on a Likert scale'}, {'measure': 'Admission to the Level II/III neonatal care unit or hospital', 'timeFrame': '14 days', 'description': 'All admissions to the Level II/III neonatal care unit following delivery'}, {'measure': 'Admission to the Level II/III neonatal care unit or hospital', 'timeFrame': '8 weeks', 'description': 'All admissions to the Level II/III neonatal care unit following delivery'}, {'measure': 'Admission to the Level II/III neonatal care unit or hospital', 'timeFrame': '6 months', 'description': 'All admissions to the Level II/III neonatal care unit following delivery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Infant, Newborn', 'hospital discharge', 'Early newborn discharge', 'Newborn length of stay', 'Maternity length of stay'], 'conditions': ['Pregnancy']}, 'descriptionModule': {'briefSummary': 'To determine the effect of a policy of early maternal-newborn infant discharge (12-24 hours) with a home visit on admission to the Level II/III nursery and hospital admissions and readmissions.', 'detailedDescription': 'This is a randomized controlled trial designed to assess the safety of a policy of early maternal newborn infant discharge compared to a policy of routine discharge 2 to 3 days after delivery. The primary outcome is newborn admissions to the Level II or Level III neonatal care unit or hospital within three days of delivery. Secondary outcomes included admissions and readmissions at 2 weeks, 6 weeks and 6 months following delivery, maternal satisfaction with length of stay and overall birthing experience, lactation continuation rates, maternal anxiety, depression, confidence and family functioning. We applied the American Academy of Pediatrics criteria for early newborn discharge, but planned the analysis by intention to treat.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All pregnant women enrolling for obstetric care at a large military academic health center\n\nExclusion Criteria:\n\n* Planning a move from the area before delivery\n* Multiple gestations\n* Pre-existing maternal diabetes\n* Maternal chronic hypertension\n* Maternal age \\< 18'}, 'identificationModule': {'nctId': 'NCT02372266', 'briefTitle': 'Safety and Cost-Effectiveness of Early Maternal Newborn Infant Discharge', 'organization': {'class': 'FED', 'fullName': '59th Medical Wing'}, 'officialTitle': 'A Randomized Controlled Trial to Assess the Safety and Cost-Effectiveness of Early Maternal Newborn Infant Discharge', 'orgStudyIdInfo': {'id': 'SGO 96-042'}, 'secondaryIdInfos': [{'id': 'DI950076', 'type': 'OTHER_GRANT', 'domain': "Department of Defense Women's Health Intramural Research"}, {'id': 'FWH19960042H', 'type': 'OTHER', 'domain': 'Wilford Hall Medical Center'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Early Discharge Group', 'description': 'If safety criteria were met, women and infants were discharged home from the hospital at 12 to 24 hours after delivery with a planned home health visit within 48 hours of the discharge.', 'interventionNames': ['Other: Early Maternal-Newborn Infant Discharge']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Routine Stay Group', 'description': 'Women and newborns were discharged no sooner than 48 hours after delivery and could stay voluntarily up to 72 hours.', 'interventionNames': ['Other: Routine discharge']}], 'interventions': [{'name': 'Early Maternal-Newborn Infant Discharge', 'type': 'OTHER', 'description': 'Discharge from the hospital between 12-24 hours of life', 'armGroupLabels': ['Early Discharge Group']}, {'name': 'Routine discharge', 'type': 'OTHER', 'description': 'Discharge of the mother and newborn 2 to 3 days after delivery', 'armGroupLabels': ['Routine Stay Group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'William H Barth, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': '59th Medical Wing', 'class': 'FED'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chairman, Department of Obstetrics and Gynecology', 'investigatorFullName': 'William H. Barth, Jr., M.D., Col(ret), USAF, MC', 'investigatorAffiliation': '59th Medical Wing'}}}}