Clinical Trials Directory

Trials / Completed

CompletedNCT02372266

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
2,223 (actual)
Sponsor
59th Medical Wing · Federal
Sex
All
Age
Healthy volunteers
Accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
OTHEREarly Maternal-Newborn Infant DischargeDischarge from the hospital between 12-24 hours of life
OTHERRoutine dischargeDischarge of the mother and newborn 2 to 3 days after delivery

Timeline

Start date
1997-04-01
Primary completion
2001-01-01
Completion
2001-08-01
First posted
2015-02-26
Last updated
2015-02-26

Source: ClinicalTrials.gov record NCT02372266. Inclusion in this directory is not an endorsement.