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Clinical Trials/NCT04422041
NCT04422041
Completed
Not Applicable

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

Universidad Autonoma de Nuevo Leon0 sites354 target enrollmentJuly 1, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hospital Readmission
Sponsor
Universidad Autonoma de Nuevo Leon
Enrollment
354
Primary Endpoint
Hospital readmission rate
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2016
End Date
July 29, 2018
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Universidad Autonoma de Nuevo Leon
Responsible Party
Principal Investigator
Principal Investigator

Erika Ochoa-Correa

Professor

Universidad Autonoma de Nuevo Leon

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Hospital readmission rate

Time Frame: 28 days

Proportion of participant newborns who were readmitted into the hospital during follow up

Secondary Outcomes

  • Rate of attention in emergency services(28 days)
  • Readmission rate associated factors(28 days)

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