Clinical trial NCT05765136: Care Outcomes in Preterm Infants Following the Implementation of Family-centered Interventions
Official title: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prematurity
Keywords: Infant, preterm
Length of stay
Neonatal intensive care
Postnatal growth
Lead sponsor: University of Turku
Sponsor class: OTHER
First posted: 2023-03-13
Enrollment: 30000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Complete preterm birth cohort included in the national Medical Birth Register

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.

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)

Primary outcomes:
measure: Length of stay
timeFrame: Immediately after discharge
Secondary outcomes:
measure: Weight
timeFrame: Immediately after discharge
measure: Length
timeFrame: Immediately after discharge
measure: Head circumference
timeFrame: Immediately after discharge
measure: Postnatal emergency visits
timeFrame: Within the first year of life (corrected gestational age) after discharge home
measure: Postnatal emergency hospitalizations
timeFrame: Within the first year of life (corrected gestational age) after discharge home
measure: Gestational age at discharge
timeFrame: Immediately after discharge
Other outcomes:
Locations:
city: Turku
country: Finland
facility: University of Turku
Study officials:
affiliation: Turku University Hospital and University of Turku
name: Liisa Lehtonen, Professor
role: PRINCIPAL_INVESTIGATOR
References: