NCT05765136

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

March 13, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

March 13, 2023

Status Verified

February 1, 2023

Enrollment Period

1.7 years

First QC Date

September 1, 2021

Last Update Submit

February 28, 2023

Conditions

Prematurity

Keywords

Infant, pretermLength of stayNeonatal intensive carePostnatal growth

Outcome Measures

Primary Outcomes (1)

  • Length of stay

    The length in days on the initial hospitalization following preterm birth

    Immediately after discharge

Secondary Outcomes (6)

  • Weight

    Immediately after discharge

  • Length

    Immediately after discharge

  • Head circumference

    Immediately after discharge

  • Postnatal emergency visits

    Within the first year of life (corrected gestational age) after discharge home

  • Postnatal emergency hospitalizations

    Within the first year of life (corrected gestational age) after discharge home

  • +1 more secondary outcomes

Study Arms (3)

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)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Complete preterm birth cohort included in the national Medical Birth Register

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Turku

Turku, 20521, Finland

RECRUITING

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Liisa Lehtonen, Professor

    Turku University Hospital and University of Turku

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kjell Helenius, MD, PhD

CONTACT

+358405597347kkhele@utu.fi

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 1, 2021

First Posted

March 13, 2023

Study Start

September 1, 2021

Primary Completion

May 1, 2023

Study Completion

May 1, 2023

Last Updated

March 13, 2023

Record last verified: 2023-02

Locations

FI(1)