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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04422041
Enrollment
354
Registered
2020-06-09
Start date
2016-07-01
Completion date
2018-07-29
Last updated
2020-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hospital Readmission, Newborn, Newborn Complication, Newborn Morbidity

Keywords

Newborn Infant, Hospital readmission, Early discharge, Very early discharge

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.

Interventions

OTHERTime 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.

OTHERDischarge 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.

Sponsors

Universidad Autonoma de Nuevo Leon
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Masking description

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

Intervention 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

Eligibility

Sex/Gender
ALL
Age
1 Minutes to 2 Days
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Hospital readmission rate28 daysProportion of participant newborns who were readmitted into the hospital during follow up

Secondary

MeasureTime frameDescription
Rate of attention in emergency services28 daysProportion of participant newborns who attended the emergency services during follow up
Readmission rate associated factors28 daysStatistical associations between the primary outcome and other variables of interest

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026