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Clinical Trials/NCT05765136
NCT05765136
Recruiting
N/A

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 site in 1 country30,000 target enrollmentSeptember 1, 2021
ConditionsPrematurity

Overview

Phase
N/A
Intervention
Not specified
Conditions
Prematurity
Sponsor
University of Turku
Enrollment
30000
Locations
1
Primary Endpoint
Length of stay
Status
Recruiting
Last Updated
3 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2021
End Date
May 2023
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Professor Liisa Lehtonen

Principal Investigator

University of Turku

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Length of stay

Time Frame: Immediately after discharge

The length in days on the initial hospitalization following preterm birth

Secondary Outcomes

  • 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)

Study Sites (1)

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