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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

354 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-01

Study Completion Date

2018-07-29

Brief Summary

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

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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.

Conditions

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Hospital Readmission Newborn Morbidity Newborn Complication Newborn

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Outcome assessors consisted of hospital staff not involved in the investigation.

Study Groups

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Early discharge

Discharge between 24 and 48 hours

Group Type ACTIVE_COMPARATOR

Discharge time between 24 and 48 hours

Intervention Type OTHER

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.

Very early discharge

Discharge in less than 24 hours

Group Type EXPERIMENTAL

Time to discharge less than 24 hours

Intervention Type OTHER

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.

Interventions

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Time to discharge less than 24 hours

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.

Intervention Type OTHER

Discharge time between 24 and 48 hours

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.

Intervention Type OTHER

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.

Minimum Eligible Age

1 Minute

Maximum Eligible Age

2 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No