Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06632769
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-07
Brief Title:
Continuous Monitoring of Body Temperature in Neonates During Skin-to-skin Care Immediately After Cesarean Section MonT Neo
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Continuous Monitoring of Body Temperature in Neonates During Skin-to-skin Care Immediately After Cesarean Section MonT Neo - a Prospective Observational Pilot Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MonT Neo
Brief Summary:
The objective of this prospective observational pilot study is to apply the adhesive thermometer SteadyTemp SteadySense GmbH Graz Austria in term neonates to monitor their body temperature non-invasively and continuously during skin-to-skin care with their mothers after Cesarean section and to compare these data with the one-time manual measurement of rectal body temperature as gold standard
Detailed Description:
Primary aim To apply the adhesive thermometer SteadyTemp SteadySense GmbH Graz Austria in term neonates in the right axillary area immediately after birth and to monitor their body temperature continuously during skin-to-skin care with their mothers after Cesarean section for 15 minutes
Secondary aim
To compare the body temperature with manually measured rectal temperature single measurement
To examine the skin condition under the adhesive patch after 15 minutes of application using the Neonatal Skin Condition Scale NSCS17
Secondary aim
To compare the body temperature with manually measured rectal temperature single measurement
To examine the skin condition under the adhesive patch after 15 minutes of application using the Neonatal Skin Condition Scale NSCS17
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None