Discharge Criteria of Preterm Infants

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

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.

Study Overview

• Status: Completed
• Conditions: 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 Type: Observational
• Enrollment (Actual): 71

Contacts and Locations

Study Locations

• Japan
  • Nagano
    • Azumino, Nagano, Japan, 39982822
      • Nagano Children's Hospita

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The postmenstrual age for each discharge criterion	The postmenstrual age for each discharge criterion that was met	at discharge (about 2 months of age)

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): July 31, 2022

Study Registration Dates

• First Submitted: November 16, 2023
• First Submitted That Met QC Criteria: November 16, 2023
• First Posted (Estimated): November 22, 2023

Study Record Updates

• Last Update Posted (Estimated): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 16, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Early discharge; Tube feeding; Family centered care; Transition to home; Neonatal home care
• Other Study ID Numbers: S-04-49

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: It might be possible only after the necessary procedures have been followed including study permissions in both study sites.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No