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临床试验/NCT04422041
NCT04422041已完成不适用

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

Universidad Autonoma de Nuevo Leon0 个研究点目标入组 354 人开始时间: 2016年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
354
主要终点
Hospital readmission rate

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

盲法说明

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

入排标准

年龄范围
1 Minute 至 2 Days(Child)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Hospital readmission rate

时间窗: 28 days

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

次要结局

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

研究者

发起方
Universidad Autonoma de Nuevo Leon
申办方类型
Other
责任方
Principal Investigator
主要研究者

Erika Ochoa-Correa

Professor

Universidad Autonoma de Nuevo Leon

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