Discharge Criteria of Preterm Infants

Sponsor

Nagano Children's Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT06144190

Collaborator

(none)

Enrollment

Location

30.9

Actual Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Length of Stay

Detailed 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.

Study Design

Study Type:

Observational

Actual Enrollment :

71 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Jan 1, 2020

Actual Primary Completion Date :

Dec 31, 2021

Actual Study Completion Date :

Jul 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

Last discharge criterion [at discharge (about 2 months of age)]
The most common last discharge criterion that was met in each study site
Effects of each discharge criterion on the length of stay [at discharge (about 2 months of age)]
The potential shortening effects of each discharge criterion on the length of stay

Secondary Outcome Measures

The postmenstrual age for each discharge criterion [at discharge (about 2 months of age)]
The postmenstrual age for each discharge criterion that was met

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nagano Children's Hospita	Azumino	Nagano	Japan	39982822

Sponsors and Collaborators

Nagano Children's Hospital

Investigators

Principal Investigator: Ryo Itoshima, MD, Nagano Children's Hospital
Study Director: Liisa Lehtonen, MD, Turku University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ryo Itoshima, Chief physician, Nagano Children's Hospital

ClinicalTrials.gov Identifier:

NCT06144190

Other Study ID Numbers:

S-04-49

First Posted:

Nov 22, 2023

Last Update Posted:

Nov 22, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ryo Itoshima, Chief physician, Nagano Children's Hospital

Study Results

No Results Posted as of Nov 22, 2023