NCT02372266|Completed
Safety and Cost-Effectiveness of Early Maternal Newborn Infant Discharge
A Randomized Controlled Trial to Assess the Safety and Cost-Effectiveness of Early Maternal Newborn Infant Discharge
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A Randomized Controlled Trial to Assess the Safety and Cost-Effectiveness of Early Maternal Newborn Infant Discharge
Sponsor study identifier
Secondary identifiers
OTHER_GRANT · Department of Defense Women's Health Intramural Research
OTHER · Wilford Hall Medical Center
interventional
2,223
0 countries
N/A
Study Start
April 1997
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2001
Actual (reported)Study Completion
August 2001
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2001
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 1997
Date type not reportedThis date has not been verified as actual or estimated.
January 2001
Actual (reported)August 2001
Actual (reported)February 3, 2015
Actual (reported)February 26, 2015
Actual (reported)Admission to the Level II/III neonatal care unit or hospital
All admissions to the Level II/III neonatal care unit following delivery
72 hours
Emergency department visits, clinic visits, or hospital admissions
72 hours
Emergency department visits, clinic visits, or hospital admissions
14 days
Emergency department visits, clinic visits, or hospital admissions
8 weeks
Emergency department visits, clinic visits, or hospital admissions
6 months
Breastfeeding score (5 point Likert scale)
At discharge (12 to 72 hours after delivery)
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.
Women and newborns were discharged no sooner than 48 hours after delivery and could stay voluntarily up to 72 hours.
Discharge from the hospital between 12-24 hours of life
Discharge of the mother and newborn 2 to 3 days after delivery
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
William H Barth, MD
Massachusetts General Hospital
2,223 participants (actual enrollment reported by the registry).
First Submitted
February 3, 2015
First Posted
February 26, 2015
Study Start
April 1997
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
January 2001
Actual (reported)Study Completion
August 2001
Actual (reported)Last Updated
February 26, 2015
Record last verified: 2015-02
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Source: ClinicalTrials.gov.
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