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临床试验/NCT05765136
NCT05765136招募中不适用

The Effects of the Close Collaboration With Parents Training and Single-family Room Architecture on the Length of Stay and Growth Parameters of Preterm Infants - a National Multicenter Study in Finland

University of Turku1 个研究点 分布在 1 个国家目标入组 30,000 人开始时间: 2021年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
30,000
试验地点
1
主要终点
Length of stay

研究概览

简要总结

The proposed study evaluates the effects of two family-centered interventions on the length of stay and outpatient visits and growth of preterm infants.The interventions are 1) the Close Collaboration with Parents training for the staff and 2) moving from traditional neonatal intensive care unit architecture to single-family room architecture.

详细描述

The Close Collaboration with Parents training targeted to the health care team of neonatal intensive care units to facilitate parental involvement in infant care and to support parenting. The training program involves a structured education process, where trained mentors educate staff in neonatal units. The duration of the training program is 18 months per unit. The training program has been implemented in eleven neonatal units in Finland since 2009; another 12 units haver not gone through the training.

The other intervention, single-family room architecture, provides facilities for parents to stay in the room of their infant throughout there 24 hour day. This intervention has been carried out in four neonatal units in Finland since 2014; in one by restructuring the existing unit, and in three by building a new unit/hospital.

In this study, the investigators are going to use national, population-based registers (the Medical Birth Register, the small Preterm Infant Register and the Hospital Discharge Register) governed by the Finnish National Institute for Health and Welfare. These registers have been widely used for observational studies, and contain data on all newborn infants in the country.

There are currently 23 neonatal units in Finland. Three units have undergone both interventions, nine units have undergone one intervention, and 12 units have undergone neither. Preterm infants (born before 35 gestational weeks) discharged from any unit will be divided into those who have been cared for all, part or no time in a hospital with an intervention, separately for each intervention. The outcome measures of interest will be related to health care utilization such as the length of stay and unscheduled outpatient visits, and to clinical outcomes such as postnatal growth parameters.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Preterm infants (gestational age <35 weeks) born in Finland between 2006 and 2020

排除标准

  • Missing data on key variables (gestational age, place of birth, length of stay)

结局指标

主要结局

Length of stay

时间窗: Immediately after discharge

The length in days on the initial hospitalization following preterm birth

次要结局

  • Weight(Immediately after discharge)
  • Gestational age at discharge(Immediately after discharge)
  • Length(Immediately after discharge)
  • Postnatal emergency visits(Within the first year of life (corrected gestational age) after discharge home)
  • Head circumference(Immediately after discharge)
  • Postnatal emergency hospitalizations(Within the first year of life (corrected gestational age) after discharge home)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Professor Liisa Lehtonen

Principal Investigator

University of Turku

研究点 (1)

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