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Development of Korean neonatal network to generate treatment indicators for the very low-birth-weight infants

Status Approved

  • First Submitted Date

    2016/02/03

  • Registered Date

    2019/05/24

  • Last Updated Date

    2019/05/10

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number    		 KCT0003983
    Unique Protocol ID 2013-E63008-00
    Public/Brief Title Development of Korean neonatal network to generate treatment indicators for the very low-birth-weight infants
    Scientific Title Development of Korean neonatal network to generate treatment indicators for the very low-birth-weight infants
    Acronym KNN
    MFDS Regulated Study No
    IND/IDE Protocol No
    Registered at Other Registry No
    Healthcare Benefit Approval Status Not applicable

  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number SMC2013-03-002-001
    Approval Date 2013-04-15
    Institutional Review Board Name samsung medical center Institutional Review Board
    Institutional Review Board Address (06351) 81 Irwon-Ro Gangnam-gu. Seoul, Korea
    Institutional Review Board Telephone 02-3410-2976
    Data Monitoring Committee Yes
    Office of research subject protection_ Research QA

  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name won soon park
    Title M.D.
    Telephone +82-2-3410-3523
    Affiliation Samsung Medical Center
    Address (06351) 81 Irwon-Ro Gangnam-gu. Seoul, Korea
    Contact Person for Public Queries
    Name so yoon ahn
    Title M.D.
    Telephone +82-2-3410-1373
    Affiliation Samsung Medical Center
    Address (06351) 81 Irwon-Ro Gangnam-gu. Seoul, Korea
    Contact Person for Updating Information
    Name hyeyoung song
    Title CRC
    Telephone +82-2-3410-3766
    Affiliation Samsung Medical Center
    Address (06351) 81 Irwon-Ro Gangnam-gu. Seoul, Korea

  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Multi-center Number of center : 64
    Overall Recruitment Status Recruiting
    Date of First Enrollment 2013-04-15 Actual
    Target Number of Participant 2000
    Primary Completion Date 2023-04-15 , Anticipated
    Study Completion Date 2023-04-15 , Anticipated
    Recruitment Status by Participating Study Site 1
    Name of Study Samsung Medical Center
    Recruitment Status Recruiting
    Date of First Enrollment 2013-04-15 ,
    Recruitment Status by Participating Study Site 2
    Name of Study Seoul National University Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2013-07-20 ,
    Recruitment Status by Participating Study Site 3
    Name of Study Asan Medical Center
    Recruitment Status Recruiting
    Date of First Enrollment 2013-05-21 ,
    Recruitment Status by Participating Study Site 4
    Name of Study Korea University Ansan Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2013-05-22 ,
    Recruitment Status by Participating Study Site 5
    Name of Study Ajou University Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2013-05-31 ,
    Recruitment Status by Participating Study Site 6
    Name of Study Seoul National University Bundang Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2013-04-22 ,
    Recruitment Status by Participating Study Site 7
    Name of Study Yonsei University Health System, Gangnam Severance Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2013-05-29 ,
    Recruitment Status by Participating Study Site 8
    Name of Study Ewha Womans University Medical Center
    Recruitment Status Recruiting
    Date of First Enrollment 2013-05-03 ,
    Recruitment Status by Participating Study Site 9
    Name of Study The Catholic University of Korea, Yeouido St. Mary's Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2013-05-28 ,
    Recruitment Status by Participating Study Site 10
    Name of Study Kangbuk Samsung Medical Center
    Recruitment Status Recruiting
    Date of First Enrollment 2013-04-27 ,
    Recruitment Status by Participating Study Site 11
    Name of Study Inje University Sanggye Paik Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2013-08-05 ,
    Recruitment Status by Participating Study Site 12
    Name of Study The Catholic University of Korea, Seoul St. Mary's Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2013-07-15 ,
    Recruitment Status by Participating Study Site 13
    Name of Study Yonsei University Health System, Severance Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2013-06-28 ,
    Recruitment Status by Participating Study Site 14
    Name of Study Wonkwang University Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2013-08-09 ,
    Recruitment Status by Participating Study Site 15
    Name of Study Korea University Anam Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2013-07-02 ,
    Recruitment Status by Participating Study Site 16
    Name of Study Gyeongsang National University Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2013-07-08 ,
    Recruitment Status by Participating Study Site 17
    Name of Study Pusan National University Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2013-11-21 ,
    Recruitment Status by Participating Study Site 18
    Name of Study Chosun University Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2013-07-20 ,
    Recruitment Status by Participating Study Site 19
    Name of Study Pusan National University Yangsan Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2013-09-16 ,
    Recruitment Status by Participating Study Site 20
    Name of Study Samsung Changwon Medical Center
    Recruitment Status Recruiting
    Date of First Enrollment 2013-10-07 ,
    Recruitment Status by Participating Study Site 21
    Name of Study Dong-A University Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2013-07-29 ,
    Recruitment Status by Participating Study Site 22
    Name of Study Kosin University Gospel Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2013-11-28 ,
    Recruitment Status by Participating Study Site 23
    Name of Study Kyungpook National University Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2013-10-08 ,
    Recruitment Status by Participating Study Site 24
    Name of Study Keimyung University Dongsan Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2013-06-28 ,
    Recruitment Status by Participating Study Site 25
    Name of Study Jeonbuk National University Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2013-09-30 ,
    Recruitment Status by Participating Study Site 26
    Name of Study Chonnam National University Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2013-07-10 ,
    Recruitment Status by Participating Study Site 27
    Name of Study Soon Chun Hyang University Hospital Cheonan
    Recruitment Status Recruiting
    Date of First Enrollment 2014-01-07 ,
    Recruitment Status by Participating Study Site 28
    Name of Study Chungnam National University Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2014-01-06 ,
    Recruitment Status by Participating Study Site 29
    Name of Study Eulji University Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2014-07-12 ,
    Recruitment Status by Participating Study Site 30
    Name of Study GangNeung Asan Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2013-10-08 ,
    Recruitment Status by Participating Study Site 31
    Name of Study Yonsei University, Wonju Severance Christian Hospital
    Recruitment Status Terminated Terminated Reason : 연구자 퇴사
    Date of First Enrollment 2013-10-15 ,
    Recruitment Status by Participating Study Site 32
    Name of Study CHA Gumi Medical Center
    Recruitment Status Recruiting
    Date of First Enrollment 2014-02-03 ,
    Recruitment Status by Participating Study Site 33
    Name of Study Kyung Hee University Hospital at Gangdong
    Recruitment Status Recruiting
    Date of First Enrollment 2014-03-31 ,
    Recruitment Status by Participating Study Site 34
    Name of Study Gachon University Gil Medical Center
    Recruitment Status Recruiting
    Date of First Enrollment 2013-10-15 ,
    Recruitment Status by Participating Study Site 35
    Name of Study Bundang CHA General Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2013-10-22 ,
    Recruitment Status by Participating Study Site 36
    Name of Study Seoul Metropolitan Government Seoul National University Boramae Medical Center
    Recruitment Status Recruiting
    Date of First Enrollment 2014-04-09 ,
    Recruitment Status by Participating Study Site 37
    Name of Study Hanyang University Seoul Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2013-10-02 ,
    Recruitment Status by Participating Study Site 38
    Name of Study KyungHee University Medical Center
    Recruitment Status Recruiting
    Date of First Enrollment 2013-11-18 ,
    Recruitment Status by Participating Study Site 39
    Name of Study Daegu Catholic University Medical Center
    Recruitment Status Recruiting
    Date of First Enrollment 2014-06-05 ,
    Recruitment Status by Participating Study Site 40
    Name of Study Busan St Mary's Hospital
    Recruitment Status Terminated Terminated Reason : 연구자 퇴사
    Date of First Enrollment 2014-01-28 ,
    Recruitment Status by Participating Study Site 41
    Name of Study The Catholic University of Korea, Bucheon St. Mary's Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2013-09-23 ,
    Recruitment Status by Participating Study Site 42
    Name of Study The Catholic University of Korea, St. Vincent's Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2014-05-28 ,
    Recruitment Status by Participating Study Site 43
    Name of Study Yeongnam University Medical Center
    Recruitment Status Recruiting
    Date of First Enrollment 2013-10-18 ,
    Recruitment Status by Participating Study Site 44
    Name of Study Ulsan Univeristy Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2013-09-27 ,
    Recruitment Status by Participating Study Site 45
    Name of Study The Catholic University of Korea, Uijeongbu St. Mary’s Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2013-10-11 ,
    Recruitment Status by Participating Study Site 46
    Name of Study Chung-Ang Univerisity Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2014-04-14 ,
    Recruitment Status by Participating Study Site 47
    Name of Study Inje University Busan Paik Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2013-09-03 ,
    Recruitment Status by Participating Study Site 48
    Name of Study Hallym University Medical Center
    Recruitment Status Terminated Terminated Reason : 연구자퇴사
    Date of First Enrollment 2014-06-12 ,
    Recruitment Status by Participating Study Site 49
    Name of Study Konyang University Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2013-07-15 ,
    Recruitment Status by Participating Study Site 50
    Name of Study Koera University Guro Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2013-12-21 ,
    Recruitment Status by Participating Study Site 51
    Name of Study Soon Chun Hyang University Hospital Seoul
    Recruitment Status Recruiting
    Date of First Enrollment 2014-05-20 ,
    Recruitment Status by Participating Study Site 52
    Name of Study Eulji University Medical Center
    Recruitment Status Recruiting
    Date of First Enrollment 2013-10-29 ,
    Recruitment Status by Participating Study Site 53
    Name of Study Soon Chun Hyang University Hospital Bucheon
    Recruitment Status Recruiting
    Date of First Enrollment 2014-05-11 ,
    Recruitment Status by Participating Study Site 54
    Name of Study Inje University Haeundae Paik Hospital
    Recruitment Status Terminated Terminated Reason : 연구자 퇴사
    Date of First Enrollment 2013-10-10 ,
    Recruitment Status by Participating Study Site 55
    Name of Study Kangwon National University Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2015-06-29 ,
    Recruitment Status by Participating Study Site 56
    Name of Study Konkuk University Medical Center
    Recruitment Status Recruiting
    Date of First Enrollment 2014-01-24 ,
    Recruitment Status by Participating Study Site 57
    Name of Study Sungae Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2013-11-13 ,
    Recruitment Status by Participating Study Site 58
    Name of Study Inje University Ilsan Paik Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2014-02-08 ,
    Recruitment Status by Participating Study Site 59
    Name of Study Cheil General Hospital and Women's Healthcare Center
    Recruitment Status Recruiting
    Date of First Enrollment 2013-08-26 ,
    Recruitment Status by Participating Study Site 60
    Name of Study Jeju National University Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2015-02-12 ,
    Recruitment Status by Participating Study Site 61
    Name of Study Hallym University Medical Center-Kangnam
    Recruitment Status Recruiting
    Date of First Enrollment 2014-01-06 ,
    Recruitment Status by Participating Study Site 62
    Name of Study Kangdong Sacred Heart Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2015-05-27 ,
    Recruitment Status by Participating Study Site 63
    Name of Study Dongguk University Ilsan Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2015-07-20 ,
    Recruitment Status by Participating Study Site 64
    Name of Study Hanyang University Guri Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2016-12-31 ,

  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Korea Centers for Disease Control and Prevention
    Organization Type Government
    Project ID 217

  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Korea Centers for Disease Control and Prevention
    Organization Type Government

  • 7. Study Summary

    Study Summary Information
    Lay Summary 
    Background and Aims: Even as South Korea rapidly becomes an aging society, with the risks of premature birth and other neonatal health risks exponentially increasing, the state of neonatal care in Korea lags behind the state of neonatal care in other advanced countries. Not only does neonatal care in Korea display a lower post-care survival rate in comparison to other advanced countries, but it also frequently leads to such complications as cerebral palsy and developmental disorders in those who survive. The overarching purpose of this research project is to develop a nationwide network of neonatal researchers and the mechanism for the network’s administration with a view to improving the survival rate of newborns with high health risks and reducing major complications of neonatal care they receive. More specifically, the project will involve developing a protocol for managing related research projects at multiple agencies and organizations, including projects on registering newborns with high health risks; improving the quality of neonatal intensive care units and their services; cohorts, and so forth.
Content and Methodology: This research proceeded through several steps, including: (1) collecting data on the frequency with which newborns with high risks are observed and other related issues; (2) analyzing the progress of related research and development in Korea and abroad; (3) developing a research protocol; (4) making a proposal for the establishment of a nationwide network for registering newborns with high health risks; (5) estimating the research cost and analyzing the cost and benefits of the project; and (6) developing a system of cooperation with experts in Korea and abroad, and suggesting a methodology for quality control. To satisfy each and every one of these goals, the researchers in this project conducted a survey of the literature and statistics on newborns with high health risks in Korea and abroad; benchmarked the advanced neonatal research networks overseas; and collected the required information and data by organizing meetings and interviews with experts. On the basis of all this work, the researchers in this project registered newborns with high health risks; improved the quality of neonatal intensive care units and their services; designed the frame of the multi-agency research project; and developed the research management protocol and the plan for its administration. 
Anticipated Benefits: In the short run, this project will provide core information and data that are necessary to generate an index that the KCDC could use to measure preventive control against major neonatal complications. Such information and data will also be necessary to design, develop, and administer a new neonatal research network especially concerning newborns with high risks. In the long run, the successful tryout and research of the neonatal research network that this project designs and develops will provide a good basis for collecting health statistics nationwide and developing appropriate measures of preventive control. Most importantly, the success of this project will help improve the quality of life for the public and reduce the socioeconomic costs associated with improving the survival rate of newborns with high health risks and reducing major neonatal complications.

  • 8. Study Design

    Study Design Information - Study Type, Observational Study Model, Time Perspective, Target Number of Participant, Cohort/Group Number, Cohort/Group, Cohort/Group Label, Cohort/Group Description, Biospecimen Collection & Archiving, Biospecimen Description
    Study Type Observational Study
    Observational Study Model Cohort
    Time Perspective Prospective  
    Target Number of Participant 2000
    Cohort/Group Number 1
    Cohort/
    Group 1

    Cohort/Group Label

    Very low birth weight infant (< birth weight 1500gram)

    Cohort/Group Description

    Demographic finding, respiratrory system, circulatory system, digestive system, discharge information observe the following items.
    Biospecimen
    Collection & Archiving    		 
    Not collect nor Archive
    Biospecimen Description 
    		
												
    
											    
										
    
									
									
								
							
    
						
    • 
						
  • 
							
    
								
    
									9. Subject Eligibility
								
    
								
							
    
							
    
								
    
									Subject Eligibility Information
									
										
											
    
												Study Population Description
												
    Very low birth weight infants (birth weight less than 1500g) admitted to neonatal intensive care units in South Korea.
    		
											
    
											
    
												Sampling Method
												
    convenience sampling
    		
											
    
										
										
    
											Condition(s)/Problem(s)
											
												
												* (P00-P96)Certain conditions originating in the perinatal period 
    
												
												
												   (P07.09)Extremely low birth weight, unspecified weight 
												
												
												

    
												(very low birth weight infant)
												
											    		
										
    
										
    
											Rare Disease
											
												
													
													No
												
											
										
    
										
    
											
												Inclusion Criteria
											
											
												
    Gender
    
												Both
											    		
										
    
										
    
											
												
    Age
    
												1Day~No Limit
											    		
										
    
										
    
											
												
    Description
    
												
    the subject should meet the folloving two criteria.

1. Very low birth weight infant (< birth weight 1500gram)

2. (1) infants who were born in the study site and admitted to its NICU(Neonatal intensive care unit) or (2) infants who were born in the hospital other than the study sites and then admitted to the NICU(Neonatal intensive care unit) of the study sites with 20 days after birth.
    
											    		
										
    
										
    
											
												Exclusion Criteria
											
											
												
    1. infants expired before 1st NICU(Neonatal intensive care unit) admission after birth


2. infants transferred to another hospital within postnatal day 28.
    
											    		
										
    
										
    
											
												Healthy Volunteers
											
											
												
													
													No
												
											
										
    
									    
								
    
							
    
						
    • 
						
  • 
							
    
								
    
									10. Outcome Measure(s)
								
    
								
							
    
							
    
								
    
									Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
									
										
    
											
												
												Type of Primary Outcome
											
											 Not applicable
										
    
										
											
    
												
													Primary Outcome(s) 1
												
											
    
											
    
												Outcome
												
    mortality
    		
											
    
											
    
												Timepoint
												
    first discharge at home from neonatal intesive care unit
    		
											
    
										
										
											
    
												
													Secondary Outcome(s) 1
												
											
    
											
    
												Outcome
												
    Bronchopulmonary dysplasia
    		
											
    
											
    
												Timepoint
												
    first discharge at home from neonatal intesive care unit
    		
											
    
										
											
    
												
													Secondary Outcome(s) 2
												
											
    
											
    
												Outcome
												
    retinopathy of prematurity
    		
											
    
											
    
												Timepoint
												
    first discharge at home from neonatal intesive care unit
    		
											
    
										
											
    
												
													Secondary Outcome(s) 3
												
											
    
											
    
												Outcome
												
    intraventricular hemorrahge
    		
											
    
											
    
												Timepoint
												
    first discharge at home from neonatal intesive care unit
    		
											
    
										
											
    
												
													Secondary Outcome(s) 4
												
											
    
											
    
												Outcome
												
    necrotizing enterocolitis
    		
											
    
											
    
												Timepoint
												
    first discharge at home from neonatal intesive care unit
    		
											
    
										
											
    
												
													Secondary Outcome(s) 5
												
											
    
											
    
												Outcome
												
    hospitalization duration
    		
											
    
											
    
												Timepoint
												
    first discharge at home from neonatal intesive care unit
    		
											
    
										
									    
								
    
							
    
						
    • 
						
  • 
							
    
								
    
									11. Study Results and Publication
								
    
								
							
    
							
    
								
    
									Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
									
										
    
											Result Registered
											
												
													
													No
												
												
												
											
										
    
										
									    
								
    
							
    
						
    • 
						
  • 
							
    
								
    
									12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
								
    
								
							
    
							
    
								
    
									Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
									
										
    
											Sharing Statement
											
												
													Yes
													
													
												
											
										
    
										
											
    
												Time of Sharing
												2021. 12
											
    
											
												
												
													
    
														Way of Sharing
														To be made available at a later date
															
																
																	
    (crchyeyoungsong@gmail.com)
																
															
														    		
													
    
												
											
										
									    
								
    
							
    
						
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