Actively Recruiting

Age: 0 - 6Months
All Genders
Healthy Volunteers
ID04720690

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

Age: 0 - 6Months
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

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

Long-term Monitoring

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

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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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Frequently Asked Questions

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