Comparison of Early Versus Very Early Postnatal Discharge on Hospital Readmissions in Newborns

Study Overview
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Brief Summary
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This study compared hospital readmission and complications between very early discharge and early discharge in healthy newborn patients.

Detailed Description
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Introduction. Very early postnatal discharge is defined as a hospital stay of the mother-child dyad of less than 24 hours. It is usually performed in public institutions of low-income countries due to high birth rates; it has not been associated to a higher proportion of neonatal admissions, however, very early discharge might increase this risk. The objective of this study was to compare the rate hospital readmission in patients with very early vs early postnatal discharge. Methods A prospective, randomized clinical study was performed with healthy term infants born in a hospital in Mexico from July 2016 to June 2018. Sample was randomized into two groups, a very early discharge group (<24 hours) and an early discharge group (24-48 hours). Hospital readmission rate was analyzed in both groups.

Official Title
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Comparison of Early Versus Very Early Postnatal Discharge on Hospital Readmissions in Newborns: A Prospective Study

Conditions
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Newborn Morbidity, Hospital Readmission, Newborn Complication, Newborn

Intervention / Treatment
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* Other: Time to discharge less than 24 hours
* Other: Discharge time between 24 and 48 hours


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy newborns that were born from vaginal delivery in primiparous or multiparous women where both the mother and the newborn were deemed as eligible for early discharge according to the American Association of Pediatrics criteria and by a clinical obstetric mother evaluation. Exclusion Criteria: Placenta praevia, abnormal bleeding during vaginal delivery (considered as greater than 500mL), inhability to deambulate, medical complications from previous a previous pregnancy, 3rd or 4th degree perineal laceration as well as medical conditions that required any monitorization for more than 24 hours after delivery.

Ages Eligible for Study
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Minimum Age: 1 Minute
Maximum Age: 2 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: They were selected based on a random computer program in a 1: 1 model, assigning each subject randomly to one of the two study groups
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Early discharge<br>Discharge between 24 and 48 hours | Other: Discharge time between 24 and 48 hours<br>* Allow the joint medical discharge of the newborn together with its mother between 24-48 hours after birth in a healthy patient, without obstetric complications and who does not present comorbidities and complications.<br>|
| Experimental: Very early discharge<br>Discharge in less than 24 hours | Other: Time to discharge less than 24 hours<br>* Allow the joint medical discharge of the newborn together with its mother in less than 24 hours after birth in a healthy patient, without obstetric complications and who does not present comorbidities and complications.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital readmission rate | Proportion of participant newborns who were readmitted into the hospital during follow up | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of attention in emergency services | Proportion of participant newborns who attended the emergency services during follow up | 28 days | 
| Readmission rate associated factors | Statistical associations between the primary outcome and other variables of interest | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Very early discharge, Newborn Infant, Hospital readmission, Early discharge