Ignite Creation Date:
2024-05-06 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04720690
Status:
RECRUITING
Last Update Posted:
2021-01-22
First Post:
2021-01-08
Brief Title:
Bioimpedence and Arterial Function Monitoring at Birth and in Infants
Sponsor:
Imperial College Healthcare NHS Trust
Organization:
Imperial College Healthcare NHS Trust
Study Overview
Official Title:
Bioimpedence and Arterial Function Monitoring at Birth and in Infants the BAMBI Study
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
RECRUITING
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:
BAMBI
Brief Summary:
Babies may be born appropriately grown for gestational age AGA 10th centile or small for gestational age SGA 10th centile Babies who are SGA and have evidence in utero of vascular compromise using antenatal doppler indices are classified as having fetal growth restriction FGR Babies with FGR are at increased risk of cardiovascular disease in adult life Increased arterial stiffness and intima-media thickness are thought to mediate this risk in adults It is not known how early in life these changes can be robustly detected In addition very little is known generally about how babies hearts and arteries change in structure and function over the first year of life whether affected by SGA or not This study aims to understand if there are differences in cardiac and arterial structure and function between babies born AGA or SGA Within the group of SGA babies the study team will investigate whether FGR and maternal pre-eclampsia influence these measurements The effects gestational age on these parameters will be studied within all groups half of the babies recruited will be 32 weeks gestational age GA and half will be 32 weeks GA Study participants will have further measurements at 3-6 months of life to assess if cardiac and arterial structure and function change in babies over the first year of life The study team will use the Vicorder device to measure arterial stiffness and assess the feasibility of using this device in neonates The Vicorder will also be used to measure cardiac output The feasibility and validity of this device for this purpose will be investigated Vicorder is not validated for cardiac output measurement in infants Vicorder cardiac output results will be compared to echocardiography and bioimpedence technology using the NICaS monitor The study team will use ultrasound for arterial structure measurements of the carotid artery and aorta
Detailed Description:
None
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