Ignite Creation Date:
2024-05-06 @ 7:43 PM
Last Modification Date:
2024-10-26 @ 3:12 PM
Study NCT ID:
NCT06105879
Status:
COMPLETED
Last Update Posted:
2023-10-30
First Post:
2023-10-12
Brief Title:
Transcutaneous Bilirubin Levels From Covered Skin
Sponsor:
Ankara Training and Research Hospital
Organization:
Ankara Training and Research Hospital
Study Overview
Official Title:
Can Transcutaneous Levels of Bilirubin Obtained From Covered Skin Replace Serum Bilirubin Measurement in Neonates Undergoing Phototherapy
Status:
COMPLETED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study was to evaluate the levels of total serum bilirubin and transcutaneous bilirubin in newborns measured in both covered and exposed areas before phototherapy 24th hour of phototherapy and 8 hours after cessation of phototherapy The study included term and preterm newborns that required phototherapy between postnatal days 0-28 Total serum bilirubin levels and transcutaneous bilirubin measurements were obtained using the MBJ20-2019 Transcutaneous Handheld Bilirubinometer Beijing MB Electronic Instruments Co Ltd China 2019 from both exposed sternal and unexposed forehead covered with a radio-opaque patch areas before at 24th hours and eight hours after phototherapy
Detailed Description:
Aim This study aimed to evaluate total serum bilirubin and transcutaneous bilirubin levels measured from covered and exposed areas in newborns before phototherapy after 24 hours of phototherapy and 8 hours after discontinuing phototherapy
Materials and Methods Term and preterm newborns who needed phototherapy between postnatal days 0-28 were included in the study Total serum bilirubin values and transcutaneous bilirubin measurements by MBJ20-2019 Transcutaneous Handheld Bilirubinometer Beijing MB Electronic Instruments Co Ltd China 2019 from the exposed area on sternum and an unexposed area forehead covered with a radioopaque patch were obtained before starting phototherapy after 24 hours of phototherapy and at 8 hours after phototherapy The results were analyzed statistically using intraclass correlation coefficients ICC
Materials and Methods Term and preterm newborns who needed phototherapy between postnatal days 0-28 were included in the study Total serum bilirubin values and transcutaneous bilirubin measurements by MBJ20-2019 Transcutaneous Handheld Bilirubinometer Beijing MB Electronic Instruments Co Ltd China 2019 from the exposed area on sternum and an unexposed area forehead covered with a radioopaque patch were obtained before starting phototherapy after 24 hours of phototherapy and at 8 hours after phototherapy The results were analyzed statistically using intraclass correlation coefficients ICC
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None