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

Not Applicable

Completed

• Conditions: Newborn Complication; Hospital Readmission; Newborn Morbidity; Newborn
• Interventions: Other: Discharge time between 24 and 48 hours; Other: Time to discharge less than 24 hours

• Registration Number: NCT04422041
• Lead Sponsor: Universidad Autonoma de Nuevo Leon

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2016-07-01
• Primary Completion: 2018-06-29
• Study Completion: 2018-07-29
• Status Verified: 2020-06
• Study First Submitted: 2020-06-04
• Study First Submitted QC: 2020-06-04
• Last Update Submitted: 2020-06-04
• Study First Posted: 2020-06-09
• Last Update Posted: 2020-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 354

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early discharge	Discharge time between 24 and 48 hours	Discharge between 24 and 48 hours
Very early discharge	Time to discharge less than 24 hours	Discharge in less than 24 hours

Primary Outcome Measures

Name	Time	Method
Hospital readmission rate	28 days	Proportion of participant newborns who were readmitted into the hospital during follow up

Secondary Outcome Measures

Name	Time	Method
Rate of attention in emergency services	28 days	Proportion of participant newborns who attended the emergency services during follow up
Readmission rate associated factors	28 days	Statistical associations between the primary outcome and other variables of interest