UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045589 |
|---|---|
| Receipt number | R000052037 |
| Scientific Title | Growth and development of the term infants with apnea in otherwise healthy: A prospective observational study |
| Date of disclosure of the study information | 2021/10/01 |
| Last modified on | 2023/10/24 15:26:15 |
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Basic information
Public title
Growth and development of the term infants with apnea in otherwise healthy: A prospective observational study
Acronym
Growth and development of the term infants with apnea in otherwise healthy
Scientific Title
Growth and development of the term infants with apnea in otherwise healthy: A prospective observational study
Scientific Title:Acronym
Growth and development of the term infants with apnea in otherwise healthy
Region
| Japan |
Condition
Condition
Apnea in the otherwise healthy, term infants
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate growth and development of the term infants with apnea in otherwise healthy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Development at the age of one and a half
Key secondary outcomes
Clinical symptoms up to one and a half years
Base
Study type
Observational
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
| Not applicable |
Age-upper limit
| 3 | days-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients who were born at term and were normally managed without any problems at the postnatal examination.
2. Patients admitted to our NICU with apnea by 3 days after birth.
3. Patients, no cause of whose apnea found by NICU discharge.
4. Patients with written consent for the participation of the study by their guardians.
Key exclusion criteria
Patients who are assessed inappropriate for the study by the investigators.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | SHINJI |
| Middle name | |
| Last name | IRIE |
Organization
National Hospital Organization Miyakonojo Medical Center
Division name
Department of pediatrics
Zip code
8850014
Address
5033-1 Iwayoshi-machi, Miyakonojo City, Miyazaki
TEL
0986234111
1.2.3.doooon@gmail.com
Public contact
Name of contact person
| 1st name | SHINJI |
| Middle name | |
| Last name | IRIE |
Organization
National Hospital Organization Miyakonojo Medical Center
Division name
Department of pediatrics
Zip code
8850014
Address
5033-1 Iwayoshi-machi, Miyakonojo City, Miyazaki
TEL
0986234111
Homepage URL
1.2.3.doooon@gmail.com
Sponsor or person
Institute
National Hospital Organization Miyakonojo Medical Center
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization Miyakonojo Medical Center
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
National Hospital Organization Miyakonojo Medical Center
Address
5033-1 Iwayoshi-machi, Miyakonojo City, Miyazaki
Tel
0986234111
621-kanrika@mail.hosp.go.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
| 2021 | Year | 10 | 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
Terminated
Date of protocol fixation
| 2021 | Year | 09 | Month | 27 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 28 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
<study design>
-observational study
-prospective study
Management information
Registered date
| 2021 | Year | 09 | Month | 28 | Day |
Last modified on
| 2023 | Year | 10 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052037
