UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047838 |
|---|---|
| Receipt number | R000054511 |
| Scientific Title | Examination of oral care methods for infants undergoing heart disease surgery using the amount of bacteria in saliva as an index |
| Date of disclosure of the study information | 2022/06/01 |
| Last modified on | 2023/05/24 10:33:37 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Examination of oral care methods for infants undergoing heart disease surgery using the amount of bacteria in saliva as an index
Acronym
Examination of oral care methods for infants undergoing heart disease surgery
Scientific Title
Examination of oral care methods for infants undergoing heart disease surgery using the amount of bacteria in saliva as an index
Scientific Title:Acronym
Examination of oral care methods for infants undergoing heart disease surgery
Region
| Japan |
Condition
Condition
Cardiovascular disease
Classification by specialty
| Pediatrics | Cardiovascular surgery | Dental medicine |
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Prevention of postoperative infection after cardiovascular surgery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Before and after surgery, the number of bacteria in saliva is measured immediately after each method (oral care using three types of mouthwash).
Key secondary outcomes
Medical record survey category (gender, date of birth, BMI, amount of feeding, Alb, presence or absence of erupted teeth, presence or absence of rodent teeth, operation time, bleeding amount, surgical method, type of prophylactic antibacterial drug, postoperative respiratory management method, operation date Presence or absence of SSI onset for 1 month, presence or absence of pneumonia for 1 month from the date of surgery)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Oral care for infants using povidone-iodine gargles.
Interventions/Control_2
Oral care for infants using Benzethonium chloride gargles.
Interventions/Control_3
Oral care for infants using water.
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 | weeks-old | <= |
Age-upper limit
| 20 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Infants undergoing thoracotomy for congenital heart disease.
Key exclusion criteria
Allergies occur withpovidone-iodine gargles or Benzethonium chloride gargles.
Doctor or dental doctor decides that oral care intervention is not possible.
Target sample size
105
Research contact person
Name of lead principal investigator
| 1st name | Hiromi |
| Middle name | |
| Last name | Honda |
Organization
Kyusyu Dental University
Division name
school of oral Health Sciences
Zip code
803-8580
Address
2-6-1,Manazuru,kokurakita-ku,kitakyushu,japan
TEL
093-285-3109
r18honda@univ.kyu-dent.ac.jp
Public contact
Name of contact person
| 1st name | Hiromi |
| Middle name | |
| Last name | Honda |
Organization
Kyusyu Dental University
Division name
school of oral Health Sciences
Zip code
803-8580
Address
2-6-1,Manazuru,kokurakita-ku,kitakyushu,japan
TEL
093-285-3109
Homepage URL
r18honda@univ.kyu-dent.ac.jp
Sponsor or person
Institute
Kyusyu Dental University
Institute
Department
Personal name
Funding Source
Organization
Kyusyu Dental University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyusyu Dental University
Address
2-6-1,Manazuru,kokurakita-ku,kitakyushu,japan
Tel
093-285-3011
kyoumu@kyu-dent.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 06 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 10 | Month | 29 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 29 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 02 | Day |
Last follow-up date
| 2025 | Year | 03 | 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
| 2022 | Year | 05 | Month | 24 | Day |
Last modified on
| 2023 | Year | 05 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054511
