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The association between development and sleep quality using cerebral oxygenation in high risk infants.

Status Approved

First Submitted Date

2016/02/02
Registered Date

2016/04/05
Last Updated Date

2016/03/29

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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	KCT0001873
Unique Protocol ID	R1522051
Public/Brief Title	The association between development and sleep quality using cerebral oxygenation in high risk infants
Scientific Title	The association between development and sleep quality using cerebral oxygenation in high risk infants.
Acronym
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	AS15195
Approval Date	2016-02-02
Institutional Review Board Name	Korea University Ansan Hospital IRB
Institutional Review Board Address
Institutional Review Board Telephone
Data Monitoring Committee

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 Hee Seo
Title	Dr.
Telephone	+82-31-412-4840
Affiliation	Korea University Ansan Hospital
Address	123, Jeokgeum-ro, Danwon-gu, Ansan-si, Gyeonggi-do, Korea
Contact Person for Public Queries
Name	Won Hee Seo
Title	Dr.
Telephone	+82-31-412-4840
Affiliation	Korea University Ansan Hospital
Address	123, Jeokgeum-ro, Danwon-gu, Ansan-si, Gyeonggi-do, Korea
Contact Person for Updating Information
Name	Won Hee Seo
Title	Dr.
Telephone	+82-31-412-4840
Affiliation	Korea University Ansan Hospital
Address	123, Jeokgeum-ro, Danwon-gu, Ansan-si, Gyeonggi-do, 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
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Recruiting
Date of First Enrollment	2016-02-03 Actual
Target Number of Participant	50
Primary Completion Date
Study Completion Date	2018-12-29 , Anticipated
Name of Study	Korea University Ansan Hospital
Recruitment Status	Recruiting
Date of First Enrollment	2016-02-03 ,

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	National Research Foundation
Organization Type	Government
Project ID	2015R1D1A1A02062170

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Korea University Ansan Hospital
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	The purpose of this study is to assess the association between development and sleep quality and measurements of cerebral oxygenation in in high risk infants including preterm and low birth weight for 24 months. We will study that the assocation between sleep status in neonatal period and development ( Bayley development) and growth (body weight, height, head circumference) in high risk neonate using by polysomnography and measurements of cerebral oxygenation using NIRS(Near infrared spectroscopy) in neonatal period. After neonatal pedriod, we will study association between sleep quality and development (language, intelligence, motor skiil) through developmental exam, sleep questionnaire and objective sleep study includingg actigraphy, PSG. (2,4,6,12,18, 24 months, corrected age)

Study Summary Information

Lay Summary

The purpose of this study is to assess the association between development and sleep quality  and measurements of cerebral oxygenation in in high risk infants including preterm and low birth weight for  24 months. 
 We will study that the assocation  between sleep status in neonatal period and development ( Bayley development) and growth (body weight, height, head circumference) in   high risk neonate  using  by polysomnography and measurements of cerebral oxygenation using NIRS(Near infrared spectroscopy) in neonatal period. 
After neonatal pedriod, we will study association between sleep quality and development (language, intelligence, motor skiil) through developmental exam, sleep questionnaire and objective sleep study includingg actigraphy, PSG. (2,4,6,12,18, 24 months, corrected age)

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	50
Cohort/Group Number	1
Cohort/ Group 1	Cohort/Group Label High risk neonate
Cohort/ Group 1	Cohort/Group Description We will study that the assocation between sleep status in neonatal period and development ( motor development) and growth (body weight, height, head circumference) in high risk neonate using by polysomnography and measurements of cerebral oxygenation using NIRS(Near infrared spectroscopy). In 2nd~3 rd year, we will study association between sleep quality and development (language, intelligence, motor skiil) through developmental exam, sleep questionnaire and objective sleep study includingg actigraphy, PSG.
Biospecimen Collection & Archiving	Not collect nor Archive
Biospecimen Description

9. Subject Eligibility

Subject Eligibility Information
Study Population Description	Preterm Neonate with initial body weight below 2500g who admit in Korea University of Ansan Hospital
Sampling Method	Nonprobability sampling
Condition(s)/Problem(s)	* (P00-P96)Certain conditions originating in the perinatal period (P07.39)Other preterm infants, unspecified weeks
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 30Day~3Year
	Description Preterm Neonate with birth body weight below 2500g
Exclusion Criteria	Intracranial hemorrhage Abnormality in congenital central nervous system Chomosomal abnormality Metabolic disease Intrauterine infection Drug history of mother during pregnancy
Healthy Volunteers	No

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	Not applicable
Outcome	Sleep stage by polysomnography, Cerebral oxygenation
Timepoint	Neonatal period, 2,4,6,12,18,24months ( corrected age )
Secondary Outcome(s) 1
Outcome	Growth, Development
Timepoint	2,4,6,12,18,24 months ( corrected age )

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

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	Not provided at time of Registration

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