Actively Recruiting
Bioimpedence and Arterial Function Monitoring at Birth and in Infants
Led by Imperial College Healthcare NHS Trust · Updated on 2024-07-29
120
Participants Needed
2
Research Sites
213 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Bioimpedence and Arterial Function Monitoring at Birth and in Infants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy term infants (including those with SGA+/-FGR) in the postnatal ward
- Term and Preterm infants (including those with SGA+/-FGR) admitted to the neonatal unit
- Written informed parental consent
You will not qualify if you...
- Antenatal or postnatal diagnosis of complex/life-limiting congenital anomaly or genetic condition
- Infants with no realistic chance of survival
- Infants with fragile skin not permitting use of cuffs for research purposes
- Babies whose parents have a limited understanding of English will be excluded in the event that communication via NHS translation services is not possible due to clinical demands on these services
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Queen Charlotte's and Chelsea Hospital
London, United Kingdom, W120HS
Actively Recruiting
2
St Mary's Hospital
London, United Kingdom, W21NY
Actively Recruiting
Research Team
J
Jayanta Banerjee, MD (Res), FRCPCH
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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