UMIN-CTR Clinical Trial

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
Email	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
Email	smstn@ka2.so-net.ne.jp

Sponsor
Institute	Patent ductus arteriosus and Left Atrial Size Evaluation study in preterm infants (PLASE) Study Group
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018352