Length of StayNCT06144190
Discharge Criteria of Preterm Infants
An observational study of Length of Stay, run by Nagano Children's Hospital at 1 site in Japan.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Length of Stay
- Type of treatment
- Injection or infusion
- How many people
- 71 participants
- Where
- 1 siteJapan
- Study dates
- 1 Jan 2020to 31 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Born between 28 and 31 weeks of gestation and
- Discharged home from the study sites between January 2020 and December 2021
Who cannot join
- Having major anomalies at birth
- Need for home oxygen therapy, tracheostomy, and/or gastrostomy at discharge
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Length of Stay
- Keywords
- Early discharge, Family centered care, Tube feeding, Transition to home, Neonatal home care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Last discharge criterion
The most common last discharge criterion that was met in each study site
Measured: 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
Measured: at discharge (about 2 months of age)
Secondary outcomes (1)
The postmenstrual age for each discharge criterion
The postmenstrual age for each discharge criterion that was met
Measured: at discharge (about 2 months of age)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start1 Jan 2020
- Primary completion31 Dec 2021
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Length of StayStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nagano Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ryo Itoshima, Nagano Children's Hospital
- Investigators
- Ryo Itoshima, MD, Principal investigator, Nagano Children's HospitalLiisa Lehtonen, MD, Study director, Turku University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06144190
- Sponsor's protocol ID
- S-04-49
- Status last verified
- Nov 2023
- First submitted
- 16 Nov 2023
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It might be possible only after the necessary procedures have been followed including study permissions in both study sites.
Publications
Itoshima R, Ojasalo V, Lehtonen L. Impact of discharge criteria on the length of stay in preterm infants: A retrospective study in Japan and Finland. Early Hum Dev. 2024 Jun;193:106016. doi: 10.1016/j.earlhumdev.2024.106016. Epub 2024 Apr 21.
PubMed 38663141
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Discharge Criteria on the Length of Stay in Preterm Infants: a Retrospective Study in Japan and Finland
- ClinicalTrials.gov ID
- NCT06144190
- Acronym / sponsor ID
- S-04-49
- Conditions
- Length of Stay
- Keywords
- Early discharge, Family centered care, Tube feeding, Transition to home, Neonatal home care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Nagano Children's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 22 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Born between 28 and 31 weeks of gestation and
- Discharged home from the study sites between January 2020 and December 2021
Key exclusion criteria (2 listed)
- Having major anomalies at birth
- Need for home oxygen therapy, tracheostomy, and/or gastrostomy at discharge
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Last discharge criterion
Time frame: 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
Time frame: at discharge (about 2 months of age)
The potential shortening effects of each discharge criterion on the length of stay
1 secondary outcome
The postmenstrual age for each discharge criterion
Time frame: at discharge (about 2 months of age)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Derived from this study: PubMed 38663141Itoshima R, Ojasalo V, Lehtonen L. Impact of discharge criteria on the length of stay in preterm infants: A retrospective study in Japan and Finland. Early Hum Dev. 2024 Jun;193:106016. doi: 10.1016/j.earlhumdev.2024.106016. Epub 2024 Apr 21.
- Individual participant dataSharing planned: Undecided. It might be possible only after the necessary procedures have been followed including study permissions in both study sites.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ryo Itoshima, MD principal investigator
Nagano Children's Hospital
Liisa Lehtonen, MD study director
Turku University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Length of Stay, run by Nagano Children's Hospital at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Last discharge criterion (time frame: at discharge (about 2 months of age)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06144190, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023.