UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016280 |
|---|---|
| Receipt number | R000018352 |
| Scientific Title | Patent ductus arteriosus and Left Atrial Size Evaluation study in preterm infants (multicenter prospective observational cohort study without interventions) |
| Date of disclosure of the study information | 2015/02/28 |
| Last modified on | 2019/07/25 10:01:35 |
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Basic information
Public title
Patent ductus arteriosus and Left Atrial Size Evaluation study in preterm infants
(multicenter prospective observational cohort study without interventions)
Acronym
PLASE study
Scientific Title
Patent ductus arteriosus and Left Atrial Size Evaluation study in preterm infants
(multicenter prospective observational cohort study without interventions)
Scientific Title:Acronym
PLASE study
Region
| Japan |
Condition
Condition
preterm infants
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1) To clarify the clinical, echocardiographic, radiologic, and laboratory findings and those changes after birth in preterm infants
2) To investigate the relationships between those clinical and diagnostic findings and clinical decision making of the medical and surgical interventions for patent ductus arteriosus as well as their prognosis
3) To provide the clues for the effective managements for the patent ductus arteriosus in preterm infants.
Basic objectives2
Others
Basic objectives -Others
1) To clarify the diagnostic findings to differentiate the infants just before PDA surgery from those without PDA surgery.
2) To clarify the most prognostic diagnostic finding at day 1, 3, and 7 for future PDA therapies.
3) To clarify the most prognostic diagnostic finding at day 1, 3, and 7 for mortality and other complications.
4) To clarify the prognostic diagnostic finding before PDA medical therapy which the most closely relates to the responsiveness of the therapy.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
PDA surgery
Key secondary outcomes
Symptomatic PDA
The number of COX inhibitor administration
Intraventricular hemorrhage (grade I-II)
Intraventricular hemorrhage (grade III- IV)
Pulmonary hemorrhage necessitating therapy
Intestinal perforation
Necrotizing enterocolitis
Chronic lung disease with moderate severity (FiO2<0.3, and no respiratory pressure support at 36 weeks of gestation)
Severe chronic lung disease (FiO2>=0.3, or respiratory pressure support at 36 weeks of gestation)
Severe retinopathy of prematurity(>= Stage3 of type I, or type 2 in Japanese criteria; or >=Stage 3 in international criteria; or who needs therapy for retinopathy)
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
| 23 | weeks-old | <= |
Age-upper limit
| 30 | weeks-old | > |
Gender
Male and Female
Key inclusion criteria
1)Neonates with gestational age at birth between 23 weeks & 0 day and 29 weeks & 6 days, and
2)Neonates who admitted to the NICUs participating in this study until 24 hours after birth, and
3)Neonates who survived 24 hours after birth.
Key exclusion criteria
Chromosomal abnormality:(13, 18, 21 trisomy, del 22q11.2, Noonan syndrome, etc).
Multiple anomalies, apparent clinical syndrome, congenital anomalies which needs operation during infancy.
Congenital heart disease other than PDA/PFO/PLSVC.
Congenital metabolic disease, endocrinologic disease, neuromuscular disease, systemic bone disease.
Family history of severe heredity disease such as neuromuscular disease or cardiomyopathy.
Neonates whose parents do not agree to provide the patients' data to the study.
Critical condition ineligible for this study, which was judged by attending physician.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Katsuaki |
| Middle name | |
| Last name | Toyoshima |
Organization
Kanagawa Children's Medical Center
Division name
Neonatology
Zip code
232-8555
Address
2-138-4 Mutsukawa, Minami-ku, Yokohama, 232-8555, Japan
TEL
045-711-2351
nqf37179@nifty.com
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Masutani |
Organization
Saitama Medical University
Division name
Pediatric Cardiology
Zip code
350-8550
Address
1981, Kamoda, Kawagoe, Saitama, 350-8550, Japan
TEL
049-228-3400
Homepage URL
smstn@ka2.so-net.ne.jp
Sponsor or person
Institute
Patent ductus arteriosus and Left Atrial Size Evaluation study in preterm infants (PLASE) Study Group
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research
(MEXT/JSPS KAKENHI )
Neonatal Research Network Japan
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
Ethical Comittie, Kanagawa children's medical center
Address
2-138-4 Mutsukawa, Minami-ku, Yokohama, 232-8555, Japan
Tel
045-711-2351
N/A
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
| 2015 | Year | 02 | Month | 28 | Day |
Related information
URL releasing protocol
http://square.umin.ac.jp/plase/data/plan2015_12_7.pdf
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/31256929
Number of participants that the trial has enrolled
710
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
Main results already published
Date of protocol fixation
| 2015 | Year | 01 | Month | 31 | Day |
Date of IRB
| 2014 | Year | 11 | Month | 21 | Day |
Anticipated trial start date
| 2015 | Year | 03 | Month | 15 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2017 | Year | 05 | Month | 07 | Day |
Date analysis concluded
| 2018 | Year | 09 | Month | 07 | Day |
Other
Other related information
multicenter prospective observational cohort study
Management information
Registered date
| 2015 | Year | 01 | Month | 20 | Day |
Last modified on
| 2019 | Year | 07 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018352
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
