Actively Recruiting
Bioimpedence and Arterial Function Monitoring at Birth and in Infants: the BAMBI Study
Led by Imperial College Healthcare NHS Trust · Updated on 2024-07-29
120
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying differences in heart and artery structure and function among babies born appropriately grown for gestational age (AGA) and those born small for gestational age (SGA), including babies with fetal growth restriction (FGR) and maternal pre-eclampsia. The study will also examine how gestational age affects these heart and artery measurements, dividing participants into groups born before 32 weeks and those born at or after 32 weeks. The goal is to understand early changes that may relate to increased cardiovascular risks later in life. Participants include three groups: AGA infants, SGA infants, and FGR infants, each group divided evenly by gestational age (<32 weeks and ≥32 weeks). The study uses the Vicorder device to measure arterial stiffness and cardiac output, though its use for cardiac output in infants is still being evaluated. Cardiac output results from Vicorder will be compared to echocardiography and NICaS monitor measurements. Ultrasound is used to assess arterial structure, including the carotid artery and aorta. Babies will have measurements taken at birth and again at 3 to 6 months to observe changes over the first year of life. Researchers will evaluate the feasibility of obtaining these measurements using the devices and compare results across different groups. The primary outcome is the proportion of babies from whom measurements are successfully obtained. Secondary outcomes include arterial stiffness measures, arterial structure, and cardiac output comparisons between birth weight and gestational age groups and among measurement devices.
CONDITIONS
Brief 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 when NHS translation services are unavailable due to clinical demand
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 years
Participants undergo measurements of arterial stiffness and cardiac output using non-invasive devices and imaging techniques.
Multiple visits over 3 years
Duration - Up to 3 years
Participants are monitored to assess arterial and cardiac function over time, including comparisons by birth weight and gestational age.
Multiple visits over 3 years
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
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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