UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053862 |
|---|---|
| Receipt number | R000061473 |
| Scientific Title | Effects of rehabilitation interventions on cardiopulmonary function for preterm infants |
| Date of disclosure of the study information | 2024/07/01 |
| Last modified on | 2024/03/14 15:05:05 |
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Basic information
Public title
Effects of rehabilitation interventions on cardiopulmonary function for preterm infants
Acronym
Effects of rehabilitation interventions on cardiopulmonary function for preterm infants
Scientific Title
Effects of rehabilitation interventions on cardiopulmonary function for preterm infants
Scientific Title:Acronym
Effects of rehabilitation interventions on cardiopulmonary function for preterm infants
Region
| Japan |
Condition
Condition
preterm infant
Classification by specialty
| Pediatrics | Nursing | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to examine the effects of rehabilitation interventions on the cardiopulmonary function and motor function for preterm infants, and the relationship between these functional changes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in heart rate, respiratory rate, and oxygen saturation after intervention
Key secondary outcomes
1. Changes in Dubowitz neurological examination scores after 1 week of intervention
2. Changes in General Movements scores after 1 week of intervention
3. Changes in Alberta Infant Motor Scale after 1 week of intervention
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
rehabilitation training (postural change, movements of limbs)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Preterm infants who receive inpatient treatment and management in a neonatal intensive care unit (NICU) and rehabilitation prescribed by their attending physician.
Key exclusion criteria
Premature infants who do not have a prescription for rehabilitation from their attending physician.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Naho |
| Middle name | |
| Last name | Kawasaki |
Organization
Graduate School of Biomedical Sciences, Nagasaki University
Division name
Division of Occupational Therapy
Zip code
852-8520
Address
1-7-1 Sakamoto, Nagasaki, Japan
TEL
095-819-7923
naho.umeki@outlook.jp
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | Murata |
Organization
Graduate School of Biomedical Sciences, Nagasaki University
Division name
Division of Occupational Therapy
Zip code
852-8520
Address
1-7-1 Sakamoto, Nagasaki, Japan
TEL
095-819-7923
Homepage URL
jmura@nagasaki-u.ac.jp
Sponsor or person
Institute
Graduate School of Biomedical Sciences, Nagasaki University
Institute
Department
Personal name
Naho Kawasaki
Funding Source
Organization
Graduate School of Biomedical Sciences, Nagasaki University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Graduate School of Biomedical Sciences, Nagasaki University
Address
1-7-1 Sakamoto, Nagasaki, Japan
Tel
095-819-7923
jmura@nagasaki-u.ac.jp
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
長崎医療センター
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 07 | 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
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
Preinitiation
Date of protocol fixation
| 2024 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 03 | Month | 14 | Day |
Last modified on
| 2024 | Year | 03 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061473
