UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057394 |
|---|---|
| Receipt number | R000065578 |
| Scientific Title | A scoping review on the practices and impact of home monitoring in preterm infants with bronchopulmonary dysplasia receiving home oxygen therapy |
| Date of disclosure of the study information | 2025/04/01 |
| Last modified on | 2025/03/25 13:34:26 |
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Basic information
Public title
A scoping review on the practices and impact of home monitoring in preterm infants with bronchopulmonary dysplasia receiving home oxygen therapy
Acronym
BPD-MONITOR
Scientific Title
A scoping review on the practices and impact of home monitoring in preterm infants with bronchopulmonary dysplasia receiving home oxygen therapy
Scientific Title:Acronym
BPD-MONITOR
Region
| Japan |
Condition
Condition
Preterm infants with bronchopulmonary dysplasia
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To understand the actual practices of home monitoring in preterm infants with neonatal chronic lung disease, including the types of devices used (e.g., pulse oximeters),
their management methods, and the clinical effectiveness of monitoring in relation to mortality, physical and neurodevelopmental outcomes, physical growth, duration of
home oxygen therapy, and family quality of life.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
To identify the actual practices and management methods of home monitoring devices (e.g., pulse oximeters) in preterm infants with neonatal chronic lung disease, and to
examine their effectiveness in relation to mortality, physical and neurodevelopmental outcomes, physical growth, duration of home oxygen therapy, and family quality of life.
Key secondary outcomes
To identify reasons for not conducting home monitoring, to explore the detailed impact of home monitoring on family quality of life (including caregiver burden and
psychological effects), and to summarize variations in monitoring practices or guidelines across countries and institutions, as well as the availability of training and support
systems related to home monitoring devices.
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 1 | days-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
- Studies involving preterm infants (<37 weeks GA) with bronchopulmonary dysplasia (BPD)
- Home oxygen therapy (HOT) initiated at NICU discharge
- Descriptions of home monitoring devices (e.g., pulse oximeters)
- Inclusion of clinical outcomes such as mortality, development, growth, duration of HOT, and family QOL
- Study types: RCTs, prospective/retrospective cohort studies, and case-control studies
- Published in Japanese or English
- Conducted in developed countries (HDI >= 0.8)
- Guidelines may also be included
Key exclusion criteria
- Case reports, books, theses, review articles, non-peer-reviewed publications
- Basic science or animal studies
- Studies focusing on chronic lung disease other than BPD (e.g., congenital malformations, chromosomal abnormalities)
- Studies with no reference to monitoring practices
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Ryo |
| Middle name | |
| Last name | Ogawa |
Organization
Nagano Children's Hospital
Division name
Division of Neonatology
Zip code
399-8288
Address
3100 Toyoshina, Azumino, Nagano
TEL
0263736700
drryo0411@gmail.com
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Ogawa |
Organization
Nagano Children's Hospital
Division name
Division of Neonatology
Zip code
399-8288
Address
3100 Toyoshina, Azumino, Nagano
TEL
0263736700
Homepage URL
drryo0411@gmail.com
Sponsor or person
Institute
Life Science Research Center, Nagano Children's Hospital
Institute
Department
Personal name
Funding Source
Organization
the Research Programme on Rare and Intractable Diseases, Health, Labor, and Welfare Sciences Research Grants
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagano Children's Hospital
Address
3100 Toyoshina, Azumino, Nagano
Tel
0263736700
drryo0411@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
0
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2025 | Year | 01 | Month | 31 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 10 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 31 | Day |
Last follow-up date
| 2025 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a scoping review based on existing literature and does not involve any clinical intervention. The purpose is to map and summarize current evidence regarding
home monitoring practices and their clinical impact in preterm infants with bronchopulmonary dysplasia (BPD).
Management information
Registered date
| 2025 | Year | 03 | Month | 25 | Day |
Last modified on
| 2025 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065578
