NCT06144190

Brief Summary

This retrospective study aims to compare discharge criteria and their impact on the length of stay using two neonatal intensive care units from two countries. The possible discharge criteria include temperature control, apnea observation, periodic respiration, least weight limit, and parents' readiness. The data were collected retrospectively in each study site.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
71

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2022

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 16, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 22, 2023

Completed
Last Updated

November 22, 2023

Status Verified

November 1, 2023

Enrollment Period

2 years

First QC Date

November 16, 2023

Last Update Submit

November 16, 2023

Conditions

Length of Stay

Keywords

Early dischargeFamily centered careTube feedingTransition to homeNeonatal home care

Outcome Measures

Primary Outcomes (2)

  • Last discharge criterion

    The most common last discharge criterion that was met in each study site

    at discharge (about 2 months of age)

  • Effects of each discharge criterion on the length of stay

    The potential shortening effects of each discharge criterion on the length of stay

    at discharge (about 2 months of age)

Secondary Outcomes (1)

  • The postmenstrual age for each discharge criterion

    at discharge (about 2 months of age)

Study Arms (2)

Japan

Preterm infants born at 28 to 31 gestational weeks in 2020-2021 in a Level IV NICU in Japan

Finland

Preterm infants born at 28 to 31 gestational weeks in 2020-2021 in a Level III NICU in Finland

Eligibility Criteria

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

Newborns who were born and taken care of in two neonatal intensive care units (NICUs): a Level IV NICU at Nagano Children's Hospital in Japan and a Level III NICU at Turku University Hospital in Finland.

You may qualify if:

  • Born between 28 and 31 weeks of gestation and
  • Discharged home from the study sites between January 2020 and December 2021

You may not qualify if:

  • Having major anomalies at birth
  • Need for home oxygen therapy, tracheostomy, and/or gastrostomy at discharge

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nagano Children's Hospita

Azumino, Nagano, 39982822, Japan

Location

Study Officials

  • Ryo Itoshima, MD

    Nagano Children's Hospital

    PRINCIPAL INVESTIGATOR

  • Liisa Lehtonen, MD

    Turku University Hospital

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

November 16, 2023

First Posted

November 22, 2023

Study Start

January 1, 2020

Primary Completion

December 31, 2021

Study Completion

July 31, 2022

Last Updated

November 22, 2023

Record last verified: 2023-11

Locations

JP(1)