Clinical trial NCT02372266: Safety and Cost-Effectiveness of Early Maternal Newborn Infant Discharge
Official title: A Randomized Controlled Trial to Assess the Safety and Cost-Effectiveness of Early Maternal Newborn Infant Discharge
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Keywords: Infant, Newborn
hospital discharge
Early newborn discharge
Newborn length of stay
Maternity length of stay
Lead sponsor: 59th Medical Wing
Sponsor class: FED
First posted: 2015-02-26
Enrollment: 2223
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* All pregnant women enrolling for obstetric care at a large military academic health center

Exclusion Criteria:

* Planning a move from the area before delivery
* Multiple gestations
* Pre-existing maternal diabetes
* Maternal chronic hypertension
* Maternal age \< 18

Primary outcomes:
measure: Admission to the Level II/III neonatal care unit or hospital
timeFrame: 72 hours
Secondary outcomes:
measure: Emergency department visits, clinic visits, or hospital admissions
timeFrame: 72 hours
measure: Emergency department visits, clinic visits, or hospital admissions
timeFrame: 14 days
measure: Emergency department visits, clinic visits, or hospital admissions
timeFrame: 8 weeks
measure: Emergency department visits, clinic visits, or hospital admissions
timeFrame: 6 months
measure: Breastfeeding score (5 point Likert scale)
timeFrame: At discharge (12 to 72 hours after delivery)
measure: Breastfeeding score (5 point Likert scale)
timeFrame: 14 days
measure: Breastfeeding score (5 point Likert scale)
timeFrame: 8 weeks
measure: Breastfeeding score (5 point Likert scale)
timeFrame: 6 months
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
measure: Maternal depression (Generalized Contentment Scale)
timeFrame: At discharge (12 to 72 hours after delivery)
measure: Maternal depression (Generalized Contentment Scale)
timeFrame: 14 days
measure: Maternal confidence (Confidence on a Likert scale)
timeFrame: At discharge (12 to 72 hours after delivery)
measure: Maternal confidence (Confidence on a Likert scale)
timeFrame: 14 days
measure: Maternal satisfaction with length of stay (Likert scale)
timeFrame: At discharge (12 to 72 hours after delivery)
measure: Maternal satisfaction with length of stay (Likert scale)
timeFrame: 14 days
measure: Maternal satisfaction with overall experience (Likert scale)
timeFrame: At discharge (12 to 72 hours after delivery)
measure: Maternal satisfaction with overall experience (Likert scale)
timeFrame: 14 days
measure: Admission to the Level II/III neonatal care unit or hospital
timeFrame: 14 days
measure: Admission to the Level II/III neonatal care unit or hospital
timeFrame: 8 weeks
measure: Admission to the Level II/III neonatal care unit or hospital
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Massachusetts General Hospital
name: William H Barth, MD
role: PRINCIPAL_INVESTIGATOR
References: