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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05765136
Enrollment
30000
Registered
2023-03-13
Start date
2021-09-01
Completion date
2023-05-31
Last updated
2023-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prematurity

Keywords

Infant, preterm, Length of stay, Neonatal intensive care, Postnatal growth

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.

Interventions

None listed

Sponsors

University of Turku
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Length of stayImmediately after dischargeThe length in days on the initial hospitalization following preterm birth

Secondary

MeasureTime frameDescription
LengthImmediately after dischargeCentimeters
Head circumferenceImmediately after dischargeCentimeters
WeightImmediately after dischargeKilograms
Postnatal emergency hospitalizationsWithin the first year of life (corrected gestational age) after discharge homeDuration of unplanned emergency outpatient hospitalizations after discharge from initial hospitalization
Gestational age at dischargeImmediately after dischargeThe corrected gestational age of the infant at final discharge from neonatal care
Postnatal emergency visitsWithin the first year of life (corrected gestational age) after discharge homeAmount of unplanned emergency outpatient visits after discharge from initial hospitalization

Countries

Finland

Contacts

Primary ContactKjell Helenius, MD, PhD
kkhele@utu.fi+358405597347

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026