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The comparison of axillary and rectal temperature in the premature infants under 32 weeks of gestation

Status Approved

First Submitted Date

2017/09/15
Registered Date

2018/02/23
Last Updated Date

2021/12/15

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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	KCT0002702
Unique Protocol ID	2017-0835
Public/Brief Title	The comparison of axillary and rectal temperature in the premature infants under 32 weeks of gestation
Scientific Title	The comparison of axillary and rectal temperature in the premature infants under 32 weeks of gestation
Acronym
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	2017-0835
Approval Date	2017-07-13
Institutional Review Board Name	Asan Medical Center Institutional Review Board
Institutional Review Board Address	Convergence Innovation bldg 88, OLYMPIC-RO 43-GIL, SONGPA-GU, SEOUL05505, KOREA
Institutional Review Board Telephone	02-3010-7165
Data Monitoring Committee	No

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	Euiseok Jung
Title	M.D.
Telephone	+82-2-3010-3372
Affiliation	Asan Medical Center
Address	88, OLYMPIC-RO 43-GIL, SONGPA-GU, SEOUL05505, KOREA
Contact Person for Public Queries
Name	MIKYOUNG CHO
Title	RN
Telephone	+82-2-3010-4770
Affiliation	Asan Medical Center
Address	88, OLYMPIC-RO 43-GIL, SONGPA-GU, SEOUL05505, KOREA
Contact Person for Updating Information
Name	MIKYOUNG CHO
Title	RN
Telephone	+82-2-3010-4770
Affiliation	Asan Medical Center
Address	88, OLYMPIC-RO 43-GIL, SONGPA-GU, SEOUL05505, 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	2017-08-04 Actual
Target Number of Participant	80
Primary Completion Date	2018-06-30 , Actual
Study Completion Date	2018-06-30 , Actual
Name of Study	Asan Medical Center
Recruitment Status	Completed
Date of First Enrollment	2017-08-04 ,

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	Asan Medical Center
Organization Type	Medical Institute
Project ID	2017-0835

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Asan Medical Center
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	We aimed to evaluate of agreement between axillary and rectal temperature measurement in preterm infants. This is a randomized, single-institution, prospective study

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	Cross-sectional
Target Number of Participant	80
Cohort/Group Number	1
Cohort/ Group 1	Cohort/Group Label under 28 weeks of gestation, 28-32weeks of gestation
Cohort/ Group 1	Cohort/Group Description axillary temperature, rectal temperature
Biospecimen Collection & Archiving	Not collect nor Archive
Biospecimen Description

9. Subject Eligibility

Subject Eligibility Information
Study Population Description	Less than 32 weeks of premature infant born at Seoul Asan Medical Center
Sampling Method	convenience sampling
Condition(s)/Problem(s)	* (P00-P96)Certain conditions originating in the perinatal period (P07.30)Other preterm infants, 28-31 completed weeks infant, premature
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 0Day~7Day
	Description Less than 32 weeks of premature infant born at Seoul Asan Medical Center
Exclusion Criteria	In case of congenital anomalies, 5 minutes Apgar score of 3 points or less, In case of administering vasoconstrictor or vasodilator which affects body temperature, or other researchers' judgment
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	Efficacy
Outcome	Difference between rectal temperature and axillary body temperature
Timepoint	From birth until the age of 7 days
Secondary Outcome(s) 1
Outcome	Difference between rectal temperature and axillary body temperature at day 7 after birth
Timepoint	7 days after birth

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	Yes Published Results Upload
Final Enrollment Number	80
Number of Publication	1
Publications 1	Mikyoung Cho, Chae Young Kim, JungBok Lee, Yumi Lee, Minhwa Park, Soohyun Bae, Yuri Kim, Yongjoo Kim, Byong Sop Lee, Ellen Ai-Rhan Kim, Ki-Soo Kim, and Euiseok Jung. Comparing Axillary and Rectal Temperature Measurements in Very Preterm Infants: A Prospective Cross-sectional Study. Neonatology. SCI. 2021-03-23 , VOL : 118 page : 180 ~ 186 https://pubmed.ncbi.nlm.nih.gov/33756484/
Results Upload	Comparing Axillary and Rectal Temperature Measurements in Very Preterm Infants_Final.docx
Date of Posting Results	2021/12/15
Protocol URL or File Upload
Brief Summary	The average AT and RT measurements were 36.52℃ and 36.71℃, respectively. The axillary measurements were lower than the rectal measurements. The mean difference in the BT measurements (between the axillary and rectal measurements), which was attributed to the methods of measurement, was 0.183℃ (0.158–0.207℃) and was statistically significant. In the subgroup analysis according to gestational age, the group of extremely preterm infants with a gestational age of < 28 weeks demonstrated an average difference of 0.188℃ between the AT and RT measurements (P = 0.013). In contrast, for the group of very preterm infants with a gestational age of 28–32 weeks, the mean difference was 0.180℃ (P < 0.0001). A stable, consistent, and significant difference in BT measurements of < 0.5℃ was observed according to the method of measurement in each group. The differences in the AT and RT measurements and the relationships between them were analyzed using correlation analysis. We identified a linear relationship between the differences in BT measurements between the two methods, which increased with increasing RT measurements. Furthermore, a slower rate of increase was observed in the AT measurements than in the RT measurements. We derived the following calibration formula to estimate the RT according to the AT: RT (℃) = −4.033 + 1.116 × AT (℃). Multivariate analysis was performed to determine the effects of environmental factors (e.g., incubator temperature, humidity, and type of ventilatory support) on the differences in BT measurements. We did not find any statistically significant correlation between any of these factors and the BT measurements.

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	No

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