Care Outcomes in Preterm Infants Following the Implementation of Family-centered Interventions

University of Turku

Status: Enrolling

Conditions: Prematurity

Study type: Observational

Funder types: Other

Identifiers

NCT05765136

VVM_LOS_2021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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)

Trial design

30,000 participants in 3 patient groups

Close collaboration group

Description:

Preterm infants born in hospitals where the Close Collaboration with Parents training program has been successfully implemented

Single-family room group

Description:

Preterm infants born in hospitals that have implemented an architectural change to single-family room design

Control group

Description:

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)