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

Sponsor
University of Turku (Other)
Overall Status
Recruiting
CT.gov ID
NCT05765136
Collaborator
(none)
30,000
1
19.9
1504.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    30000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    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
    Actual Study Start Date :
    Sep 1, 2021
    Anticipated Primary Completion Date :
    May 1, 2023
    Anticipated Study Completion Date :
    May 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Close collaboration group

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

    Single-family room group

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

    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)

    Outcome Measures

    Primary Outcome Measures

    1. Length of stay [Immediately after discharge]

      The length in days on the initial hospitalization following preterm birth

    Secondary Outcome Measures

    1. Weight [Immediately after discharge]

      Kilograms

    2. Length [Immediately after discharge]

      Centimeters

    3. Head circumference [Immediately after discharge]

      Centimeters

    4. Postnatal emergency visits [Within the first year of life (corrected gestational age) after discharge home]

      Amount of unplanned emergency outpatient visits after discharge from initial hospitalization

    5. Postnatal emergency hospitalizations [Within the first year of life (corrected gestational age) after discharge home]

      Duration of unplanned emergency outpatient hospitalizations after discharge from initial hospitalization

    6. Gestational age at discharge [Immediately after discharge]

      The corrected gestational age of the infant at final discharge from neonatal care

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts 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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Turku Turku Finland 20521

    Sponsors and Collaborators

    • University of Turku

    Investigators

    • Principal Investigator: Liisa Lehtonen, Professor, Turku University Hospital and University of Turku

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Professor Liisa Lehtonen, Principal Investigator, University of Turku
    ClinicalTrials.gov Identifier:
    NCT05765136
    Other Study ID Numbers:
    • VVM_LOS_2021
    First Posted:
    Mar 13, 2023
    Last Update Posted:
    Mar 13, 2023
    Last Verified:
    Feb 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Professor Liisa Lehtonen, Principal Investigator, University of Turku
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 13, 2023