Bioimpedence and Arterial function Monitoring at Birth and in Infants
Research type
Research Study
Full title
Bioimpedence and Arterial function Monitoring at Birth and in Infants: the BAMBI study
IRAS ID
287610
Contact name
Jayanta Banerjee
Contact email
Sponsor organisation
Imperial College London
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 11 months, 30 days
Research 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 (such as heart attacks or strokes) in adult life. Increased arterial stiffness and 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, we will study whether FGR and maternal pre-eclampsia influence these measurements. We will study what effects gestational age has on these parameters 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.
We will use the Vicorder device to measure arterial stiffness, and assess the feasibility of using this device in neonates. We will also use it to measure cardiac output, and assess the feasibility and validity of the device for this purpose (Vicorder is not validated for cardiac output measurement in infants). Vicorder results will be compared to echocardiography and bioimpedence technology (using the NICaS monitor). We will use ultrasound for arterial structure measurements of the carotid artery and aorta.
REC name
West of Scotland REC 3
REC reference
20/WS/0133
Date of REC Opinion
6 Nov 2020
REC opinion
Further Information Favourable Opinion