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NCT06144190 Clinical Trial

Discharge Criteria of Preterm Infants

Length of Stay Clinical Trial

Official title:
Impact of Discharge Criteria on the Length of Stay in Preterm Infants: a Retrospective Study in Japan and Finland

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06144190
Other study ID # S-04-49
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2020
Est. completion date July 31, 2022

Study information
Verified date November 2023
Source Nagano Children's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Description:

Aims: To compare discharge criteria and their impact on the length of stay among preterm infants in Japan and Finland. The possible discharge criteria include temperature control, apnea observation, periodic respiration, least weight limit, and parents' readiness. Study design and settings: This is a retrospective comparison study in two NICUs: a Level IV in Japan and a Level III in Finland. Patients: Eligible infants are those who were born between 28+0 and 31+6 weeks of gestation and who were discharged home from the study sites between January 2020 and December 2021. Infants will be excluded if (1) they have major anomalies at birth, (2) they are not discharged home from the study sites, or (3) they are discharged home with oxygen and/or after tracheostomy. Outcome measures: The primary outcomes are the most common last discharge criterion between the two NICUs, and the potential shortening effects of each discharge criterion on the length of stay. The secondary outcome is the postmenstrual age (PMA) for each discharge criterion. Statistics: The comparison between two continuous variables will be carried out by the student t test. Ethics: The Ethics Committee of Nagano Children's Hospital gave ethical approval to this study. The study permission was obtained in both study sites.

Recruitment information / eligibility
Status Completed
Enrollment 71
Est. completion date July 31, 2022
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Born between 28 and 31 weeks of gestation and - Discharged home from the study sites between January 2020 and December 2021 Exclusion Criteria: - Having major anomalies at birth - Need for home oxygen therapy, tracheostomy, and/or gastrostomy at discharge

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Japan Nagano Children's Hospita Azumino Nagano

Sponsors (1)
Lead Sponsor Collaborator
Nagano Children's Hospital

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Last discharge criterion The most common last discharge criterion that was met in each study site at discharge (about 2 months of age)
Primary 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 The postmenstrual age for each discharge criterion The postmenstrual age for each discharge criterion that was met at discharge (about 2 months of age)
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