UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053350 |
|---|---|
| Receipt number | R000060580 |
| Scientific Title | A preterm infant life-saving package including a simple and affordable incubator and a portable flow generator mask-CPAP in resource-limited settings. SAVE Preterm trial, Saving preterm infants by Adopting Vital Equipment. |
| Date of disclosure of the study information | 2024/01/16 |
| Last modified on | 2024/02/19 14:12:24 |
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Basic information
Public title
A preterm infant life-saving package including a simple and affordable incubator and a portable flow generator mask-CPAP in resource-limited settings.
SAVE Preterm trial, Saving preterm infants by Adopting Vital Equipment.
Acronym
SAVE Preterm trial
Scientific Title
A preterm infant life-saving package including a simple and affordable incubator and a portable flow generator mask-CPAP in resource-limited settings.
SAVE Preterm trial, Saving preterm infants by Adopting Vital Equipment.
Scientific Title:Acronym
SAVE Preterm trial
Region
| Asia(except Japan) | Africa |
Condition
Condition
Preterm birth complications
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The case fatality rate in preterm infants varies by their birth weight. We hypothesize that the package with an incubator and respiratory device would most effectively improve the mortality and morbidity of preterm infants. The incubator can safely provide a neutral environment, in which these newborn babies minimize their energy consumption, and the portable flow generator mask-CPAP can continuously provide the necessary breathing support. It can treat the complications of preterm infants, such as hypothermia and breathing problems. These devices are designed to be used in resource-limited settings and have the potential to save a large number of newborns in developing countries.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome is survival to hospital discharge. In the research area, patients may be discharged to home care if high mortality is anticipated. Such discharges are also included in the category of survival discharge.
Key secondary outcomes
The secondary outcome is in-hospital mortality within 28 days of birth including death confirmed through telephone follow-up post-discharge.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Body temperature management with a simple and affordable incubator and respiratory support with a portable flow generator mask-CPAP.
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
| 2 | days-old | > |
Gender
Male and Female
Key inclusion criteria
Preterm infants who birth weight are from 1,200 to 1,799g with respiratory failure.
Key exclusion criteria
Neonates with congenital malformations.
Target sample size
350
Research contact person
Name of lead principal investigator
| 1st name | Eiji |
| Middle name | |
| Last name | Hirakawa |
Organization
Kagoshima City Hospital
Division name
Department of Neonatology
Zip code
890-8760
Address
37-1 Ue-Arata, Kagoshima, Kagoshima, JAPAN
TEL
099-230-7000
hirakawaeiji@gmail.com
Public contact
Name of contact person
| 1st name | Eiji |
| Middle name | |
| Last name | Hirakawa |
Organization
Kagoshima City Hospital
Division name
Department of Neonatology
Zip code
890-8760
Address
37-1 Ue-Arata, Kagoshima, Kagoshima, JAPAN
TEL
0990-230-7000
Homepage URL
hirakawaeiji@gmail.com
Sponsor or person
Institute
Kagoshima City Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
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
Nagasaki University School of tropical medicine and global health
Address
1-12-4 Sakamoto, Nagasaki, Nagasaki, JAPAN
Tel
+81-95-819-7008
tmgh_irb@ml.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
Savannakhet Provincial Hospital, Lao PDR.
Champasak Provincial Hospital, Lao PDR.
Khammouan Provincial Hospital, Lao PDR.
Saravan Provincial Hospital, Lao PDR.
Bo government Hospital, Republic of Sierra Leone.
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 01 | Month | 16 | 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
| 2022 | Year | 12 | Month | 22 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 22 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 01 | 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 | 01 | Month | 15 | Day |
Last modified on
| 2024 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060580
