Safety and Cost-Effectiveness of Early Maternal Newborn Infant Discharge

Study Overview
=================
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.

Official Title
-----------------
A Randomized Controlled Trial to Assess the Safety and Cost-Effectiveness of Early Maternal Newborn Infant Discharge

Conditions
-----------------
Pregnancy

Intervention / Treatment
-----------------
* Other: Early Maternal-Newborn Infant Discharge
* Other: Routine discharge


Participation Criteria
=================
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
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early Discharge Group<br>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. | Other: Early Maternal-Newborn Infant Discharge<br>* Discharge from the hospital between 12-24 hours of life<br>|
| Active Comparator: Routine Stay Group<br>Women and newborns were discharged no sooner than 48 hours after delivery and could stay voluntarily up to 72 hours. | Other: Routine discharge<br>* Discharge of the mother and newborn 2 to 3 days after delivery<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emergency department visits, clinic visits, or hospital admissions | Any unplanned pediatric visit to an emergency room, clinic or a hospital admission | 72 hours | 
| Emergency department visits, clinic visits, or hospital admissions | Any unplanned pediatric visit to an emergency room, clinic or a hospital admission | 14 days | 
| Emergency department visits, clinic visits, or hospital admissions | Any unplanned pediatric visit to an emergency room, clinic or a hospital admission | 8 weeks | 
| Emergency department visits, clinic visits, or hospital admissions | Any unplanned pediatric visit to an emergency room, clinic or a hospital admission | 6 months | 
| Breastfeeding score (5 point Likert scale) | 5 point Likert scale: Only breast, mostly breast, 50/50, mostly bottle, only bottle | At discharge (12 to 72 hours after delivery) | 
| Breastfeeding score (5 point Likert scale) | 5 point Likert scale: Only breast, mostly breast, 50/50, mostly bottle, only bottle | 14 days | 
| Breastfeeding score (5 point Likert scale) | 5 point Likert scale: Only breast, mostly breast, 50/50, mostly bottle, only bottle | 8 weeks | 
| Breastfeeding score (5 point Likert scale) | 5 point Likert scale: Only breast, mostly breast, 50/50, mostly bottle, only bottle | 6 months | 
| Maternal anxiety (State/Trait Anxiety Inventory) |  | At discharge (12 to 72 hours after delivery) | 
| Maternal anxiety (State/Trait Anxiety Inventory) | State/Trait Anxiety Inventory | 14 days | 
| Maternal depression (Generalized Contentment Scale) | Generalized Contentment Scale | At discharge (12 to 72 hours after delivery) | 
| Maternal depression (Generalized Contentment Scale) | Generalized Contentment Scale | 14 days | 
| Maternal confidence (Confidence on a Likert scale) | Confidence on a Likert scale | At discharge (12 to 72 hours after delivery) | 
| Maternal confidence (Confidence on a Likert scale) | Confidence on a Likert scale | 14 days | 
| Maternal satisfaction with length of stay (Likert scale) | Satisfaction with length of stay on a Likert scale | At discharge (12 to 72 hours after delivery) | 
| Maternal satisfaction with length of stay (Likert scale) | Satisfaction with length of stay on a Likert scale | 14 days | 
| Maternal satisfaction with overall experience (Likert scale) | Satisfaction with overall childbirth experience on a Likert scale | At discharge (12 to 72 hours after delivery) | 
| Maternal satisfaction with overall experience (Likert scale) | Satisfaction with overall childbirth experience on a Likert scale | 14 days | 
| Admission to the Level II/III neonatal care unit or hospital | All admissions to the Level II/III neonatal care unit following delivery | 14 days | 
| Admission to the Level II/III neonatal care unit or hospital | All admissions to the Level II/III neonatal care unit following delivery | 8 weeks | 
| Admission to the Level II/III neonatal care unit or hospital | All admissions to the Level II/III neonatal care unit following delivery | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Infant, Newborn, hospital discharge, Early newborn discharge, Newborn length of stay, Maternity length of stay