UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040711 |
|---|---|
| Receipt number | R000046474 |
| Scientific Title | Effectiveness of the low-cost, portable, BUBBLE INCUBATOR for premature neonates in Republic of Sierra Leone |
| Date of disclosure of the study information | 2020/06/10 |
| Last modified on | 2020/06/10 15:45:12 |
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Basic information
Public title
Effectiveness of the low-cost, portable, BUBBLE INCUBATOR for premature neonates in Republic of Sierra Leone
Acronym
Effectiveness of the low-cost, portable, BUBBLE INCUBATOR for premature neonates in Republic of Sierra Leone
Scientific Title
Effectiveness of the low-cost, portable, BUBBLE INCUBATOR for premature neonates in Republic of Sierra Leone
Scientific Title:Acronym
Effectiveness of the low-cost, portable, BUBBLE INCUBATOR for premature neonates in Republic of Sierra Leone
Region
| Africa |
Condition
Condition
premature neonates
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study evaluated a low-cost portable bubble incubator (Atom Medical Inc, Tokyo, Japan) that does not require an electric power supply for neonatal intensive care at Ola During Children's Hospital, a tertiary care children's hospital in Sierra Leone.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome was the time that the body temperature remained at or above 36.5 degrees.
Key secondary outcomes
The secondary outcome that the temperature inside the incubator remained at or above 34 degrees.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
The study was conducted over two weeks between January 8 and 27, 2020. Neonates weighing 800 to 2000gram, with stable respiration and born at Ola During Children's Hospital were enrolled. Heart rate and SpO2 were continuously measured by pulse oximeters on the wrist or sole of the neonates. The same type of thermometer was used to measure the temperatures inside the bubble incubator, outside the bubble incubator, and the surface temperature of the hot water container insulation. The axillary temperature of the neonate was measured. The temperature inside the bubble incubator was measured by a probe positioned at its center. The probe for measuring the external temperature was positioned at the same height as the incubator. The oxygen concentration in the bubble incubator was measured by an oximeter placed approximately 10 cm above the mouth of the neonate. An oximeter rather than a CO2 meter was used for reasons of safety. A cylinder of water was heated when the temperature inside the bubble incubator was 32degees or less or the body temperature was 36.5 degrees or less. The body temperature of the newborns was measured every 4 hours for 24 hours before the start of the research. Body temperature, the temperature inside and outside the bubble incubator, and the surface temperature of the insulation around the water containers were measured every 15 minutes after the start of the study or turning the water heater on. The measurements were continued hourly unless the bubble incubator and body temperatures became too high. The neonates were taken out of the bubble incubator after 22 hours, and returned to a cot with monitoring of their body temperature and the environmental temperature of the intensive care unit every 4 hours for 24 hours.
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
Female
Key inclusion criteria
Newborn admitted to Ola During Children's Hospital.
Newborns from 800g to 2000g.
Written informed consent of the patient or his/her formal representative.
Key exclusion criteria
When informed consent cannot be obtained.
Newborns with fatal congenital diseases.
Newborns with critical conditions (breathing disorder, sepsis).
Newborns under 800g over 2000g.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Shuusaku |
| Middle name | |
| Last name | Kobori |
Organization
Funabashi Central Hospital
Division name
Perinatal Center
Zip code
273-8556
Address
6-13-10 Kaijin, Funabashi City, Chiba
TEL
0474332111
kobochannurann9@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Shuusaku |
| Middle name | |
| Last name | Kobori |
Organization
Funabashi Central Hospital
Division name
Perinatal Center
Zip code
273-8556
Address
6-13-10 Kaijin, Funabashi City, Chiba
TEL
0474332111
Homepage URL
kobochannurann9@yahoo.co.jp
Sponsor or person
Institute
Funabashi Central Hospital
Institute
Department
Personal name
Funding Source
Organization
Atom Medical Inc
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sierra Leone Ethics and Scientific Review Committee
Address
Ministry of Health and Sanitation Directorate of Policy, Planning & Information (DPPI) Youyi Building, Fifth Floor, East Wing
Tel
23278366493
efoday@health.gov.sl
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
Ola During Children's Hospital
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 06 | Month | 10 | 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
5
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
Completed
Date of protocol fixation
| 2019 | Year | 12 | Month | 28 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 09 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 09 | Day |
Last follow-up date
| 2020 | Year | 01 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 06 | Month | 10 | Day |
Last modified on
| 2020 | Year | 06 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046474
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