Care Outcomes in Preterm Infants Following the Implementation of Family-centered Interventions
NCT ID: NCT05765136
Last Updated: 2023-03-13
Study Results
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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UNKNOWN
30000 participants
OBSERVATIONAL
2021-09-01
2023-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Close collaboration group
Preterm infants born in hospitals where the Close Collaboration with Parents training program has been successfully implemented
No interventions assigned to this group
Single-family room group
Preterm infants born in hospitals that have implemented an architectural change to single-family room design
No interventions assigned to this group
Control group
Preterm infants born in hospitals that have not gone through any of the two aforementioned interventions (single-family room architecture or Close Collaboration with Parents training program)
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
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University of Turku
OTHER
Responsible Party
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Professor Liisa Lehtonen
Principal Investigator
Principal Investigators
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Liisa Lehtonen, Professor
Role: PRINCIPAL_INVESTIGATOR
Turku University Hospital and University of Turku
Locations
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University of Turku
Turku, , Finland
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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VVM_LOS_2021
Identifier Type: -
Identifier Source: org_study_id
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