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Comparative analysis of the clinical effectiveness for capillary blood sampling in term newborns: laser lancing device versus automatic incision device. Randomized, Non-inferiority study.

Status Approved

First Submitted Date

2020/03/30
Registered Date

2020/04/08
Last Updated Date

2021/10/18

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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	KCT0004901
Unique Protocol ID	2020AS0077
Public/Brief Title	Comparative analysis of the clinical effectiveness for capillary blood sampling in term newborns: laser lancing device versus automatic incision device.
Scientific Title	Comparative analysis of the clinical effectiveness for capillary blood sampling in term newborns: laser lancing device versus automatic incision device. Randomized, Non-inferiority study.
Acronym
MFDS Regulated Study	No
IND/IDE Protocol
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	2020AS0077
Approval Date	2020-03-24
Institutional Review Board Name	Korea University Ansan Hospital Institutional Review Board
Institutional Review Board Address	123, Jeokgeum-ro, Danwon-gu, Ansan-si, Gyeonggi-do
Institutional Review Board Telephone	031-412-6514
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	Byung Min Choi
Title	Professor
Telephone	+82-31-412-5551
Affiliation	Korea University Ansan Hospital
Address	123, Jeokgeum-ro, Danwon-gu, Ansan-si, Gyeonggi-do, Republic of Korea
Contact Person for Public Queries
Name	Eui Kyung Choi
Title	professor
Telephone	+82-31-412-5551
Affiliation	Korea University Ansan Hospital
Address	123, Jeokgeum-ro, Danwon-gu, Ansan-si, Gyeonggi-do, Republic of Korea
Contact Person for Updating Information
Name	Eui Kyung Choi
Title	professor
Telephone	+82-31-412-5551
Affiliation	Korea University Ansan Hospital
Address	123, Jeokgeum-ro, Danwon-gu, Ansan-si, Gyeonggi-do, Republic of 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	Completed
Date of First Enrollment	2020-06-09 Actual
Target Number of Participant	42
Primary Completion Date	2021-09-17 , Actual
Study Completion Date	2021-09-17 , Actual
Name of Study	Korea University Ansan Hospital
Recruitment Status	Completed
Date of First Enrollment	2020-06-09 ,

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 University Ansan Hospital
Organization Type	Medical Institute
Project ID

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	When newborn babies for blood sampling, it is widely used because it is easier and safer to collect capillary blood by placing the heel of a newborn in a "heel puncture" rather than in an artery or vein. However, not only can the heel cause pain in newborns, but it can also be a new risk factor, such as bruises and infections. The automatic incision device is widely used in Korea instead of a manual lancet in the past. An automatic incision device that automatically moves the blade back and forth, designed to reduce pain by cutting the blood vessels in the upper part of the skin and not touching the pain nerve fibers that are located deep, and to facilitate extraction that is less affected by the nurse's proficiency than the passive needle's. Recently, laser lancet device (HandyRay ®) have been marketed in Korea after obtaining a KFDA license. This is reported to have the advantages of reducing the risk and pain of secondary infections and improving the healing process of wounds, compared to the needle or blade used to collect capillary blood from the fingers in adult diabetics. Aim of our study The clinical usefulness of laser lancet device (handyRay ®) for capillary blood collection in full-term newborn babies and automated incision device are to be compared and analyzed. Therefore, we would compare and observe efficacy of blood collection, pain reactions and wound healing processes. Hypothesis There will be no difference in clinical usefulness between laser lancet device (handyRay ®) for capillary blood collection and automated incisional device.

Study Summary Information

Lay Summary

When newborn babies for blood sampling, it is widely used because it is easier and safer to collect capillary blood by placing the heel of a newborn in a &quot;heel puncture&quot; rather than in an artery or vein. However, not only can the heel cause pain in newborns, but it can also be a new risk factor, such as bruises and infections.
The automatic incision device is widely used in Korea instead of a manual lancet in the past. An automatic incision device that automatically moves the blade back and forth, designed to reduce pain by cutting the blood vessels in the upper part of the skin and not touching the pain nerve fibers that are located deep, and to facilitate extraction that is less affected by the nurse&#39;s proficiency than the passive needle&#39;s.
Recently, laser lancet device (HandyRay ®) have been marketed in Korea after obtaining a KFDA license. This is reported to have the advantages of reducing the risk and pain of secondary infections and improving the healing process of wounds, compared to the needle or blade used to collect capillary blood from the fingers in adult diabetics.

Aim of our study
The clinical usefulness of laser lancet device (handyRay ®) for capillary blood collection in full-term newborn babies and automated incision device are to be compared and analyzed. Therefore, we would compare and observe efficacy of blood collection, pain reactions and wound healing processes.

Hypothesis
There will be no difference in clinical usefulness between laser lancet device (handyRay ®) for capillary blood collection and automated incisional device.

8. Study Design

Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
Study Type	Interventional Study
Study Purpose	Supportive Care
Phase	Not applicable
Intervention Model	Cross-over
Blinding/Masking	Open
Allocation	RCT
Intervention Type	Medical Device
Intervention Description	Groups A and B are randomly assigned to the infants who meet the selection criteria of this study before starting the study. Put notes from group A and group B in an invisible envelope and seal them so that they cannot be opened, and store them in random order. The envelopes are opened in order and assigned to groups A and B. Group A first uses laser lancet device to collect blood, and the next day, the same amount is collected using automatic incision device.The B group first uses automatic incision device to collect the same amount of blood the next day using laser lancet device. When using a laser lancet device, prepare by referring to the instructions for use. The laser adjustment phase (Level 1 through 5) is followedby the Level 2 for collecting blood. If sufficient amount of blood is not collected, repeat the puncture by Level 3. If sufficient amount is not collected, it is defined as failure. When using an automatic incision device, prepare by referring to the instructions for use. Among two types of BD Quikheel® Lancet (Infant for Preemie), start collecting blood for Infant type. If not enough blood is collected, it is defined as failure. Side effects of infant capillary blood collection typically include bleeding, pain, bruising, infection and discoloration both of which are at risk.
Number of Arms	2
Arm 1	Arm Label B group
	Target Number of Participant 42
	Arm Type Others
	Arm Description The B group first uses automatic incision device to collect the same amount of blood the next day using laser lancet device. When using an automatic incision device, prepare by referring to the instructions for use. Among two types of BD Quikheel® Lancet (Infant for Preemie), start collecting blood for Infant type. If not enough blood is collected, it is defined as failure. When using a laser lancet device, prepare by referring to the instructions for use. The laser adjustment phase (Level 1 through 5) is followed by the Level 2 for collecting blood. If sufficient amount of blood is not collected, repeat the puncture by Level 3. If sufficient amount is not collected, it is defined as failure.
Arm 2	Arm Label A group
	Target Number of Participant 42
	Arm Type Others
	Arm Description Group A first uses laser lancet device to collect blood, and the next day, the same amount is collected using automatic incision device. When using a laser lancet device, prepare by referring to the instructions for use. The laser adjustment phase (Level 1 through 5) is followed by the Level 2 for collecting blood. If sufficient amount of blood is not collected, repeat the puncture by Level 3. If sufficient amount is not collected, it is defined as failure. When using an automatic incision device, prepare by referring to the instructions for use. Among two types of BD Quikheel® Lancet (Infant for Preemie), start collecting blood for Infant type. If not enough blood is collected, it is defined as failure.

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	Not Applicable-Etc Jaundice, Neonatal
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 1Day~6Month
	Description - Full term neonate admitted to Korea University Ansan Hospital. - When capillary blood gas analysis or bilirubin examination is required for more than two consecutive days - Clinical hemodynamic conditions have been identified to allow capillary blood to be collected with the heel sampling - If the parents of the study participants voluntarily sign the informed consent
Exclusion Criteria	- In case of an unstable hemodynamic condition, such as congenital heart disease or severe respiratory difficulty, which affects the time of capillary refill - If no blood test is required - Premature babies under 37 weeks of 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	/Safety/Efficacy
Outcome	Efficacy of blood sampling and pain score assesment
Timepoint	Immediate after procedure
Secondary Outcome(s) 1
Outcome	The skin damage caused by sampling
Timepoint	every day after procedure

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. 3
Way of Sharing	Available on Request (ekchoi03@korea.ac.kr)

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