Arterial StiffnessBAMBINCT04720690
Bioimpedence and Arterial Function Monitoring at Birth and in Infants
An observational study of Arterial Stiffness and Fetal Growth Retardation, run by Imperial College Healthcare NHS Trust at 2 sites in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages Up to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Arterial Stiffness, Fetal Growth Retardation, Small for Gestational Age at Delivery
- What is being tested?
- Vicorder: pulse wave velocity, pulse wave analysis, stroke volume, cardiac output, NICaS and Echocardiography and ultrasound of arteries
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 1 Dec 2020to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 6 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: All term and preterm infants born at the Imperial College Healthcare NHS trust can be included to the study after parental consent.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites, 2 recruiting
- Recruiting
Queen Charlotte's and Chelsea Hospital
London, W120HS
Jayanta Banerjee, MD (Res), FRCPCH, 020 3313 7308, j.banerjee@imperial.ac.uk
- Recruiting
St Mary's Hospital
London, W21NY
Jayanta Banerjee, MD (Res), FRCPCH, 020 3313 7308, j.banerjee@imperial.ac.uk
About this study
Official title: Bioimpedence and Arterial Function Monitoring at Birth and in Infants: the BAMBI Study
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
- Arterial Stiffness, Fetal Growth Retardation, Small for Gestational Age at Delivery, Pre-Eclampsia
- Being tested
- Vicorder: pulse wave velocity, pulse wave analysis, stroke volume, cardiac output, NICaS, Echocardiography and ultrasound of arteries
- Medical subject headings
- Fetal Growth Retardation, Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vicorder: pulse wave velocity, pulse wave analysis, stroke volume, cardiac outputDevice
Measurement of arterial stiffness and cardiac output
NICaSDevice
Measurement of cardiac output
Echocardiography and ultrasound of arteriesDevice
Measurement of cardiac output; measurement of intima-media thickness of arteries
| Study group | Role | What they receive |
|---|---|---|
| Appropriately grown for age infants | 40 appropriately grown for gestational age (AGA) infants. 20 will be <32 weeks, and 20 will be ≥32 weeks gestational age at birth. Receives: Device: Vicorder: pulse wave velocity, pulse wave analysis, stroke volume, cardiac output; Device: NICaS; Device: Echocardiography and ultrasound of arteries | |
| Small for gestational age infants | 40 small for gestational age (SGA) infants. 20 will be <32 weeks, and 20 will be ≥32 weeks gestational age at birth. Receives: Device: Vicorder: pulse wave velocity, pulse wave analysis, stroke volume, cardiac output; Device: NICaS; Device: Echocardiography and ultrasound of arteries | |
| Fetal growth restricted infants | 40 fetal growth restricted (FGR) infants. 20 will be <32 weeks, and 20 will be ≥32 weeks gestational age at birth. Receives: Device: Vicorder: pulse wave velocity, pulse wave analysis, stroke volume, cardiac output; Device: NICaS; Device: Echocardiography and ultrasound of arteries |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of arterial and cardiac function measurements: the proportion of babies from whom study measurements are successfully obtained.
Feasibility of arterial and cardiac function measurements assessed through establishing from what proportion of babies the team is able to successfully obtain these measurements.
Measured: 3 years
Secondary outcomes (5)
Non-invasive measurement of arterial stiffness: brachial-femoral pulse wave velocity
Brachial-femoral pulse wave velocity in metres per second (m/s) will be measured using the Vicorder and compared between neonates of different gestational age and birth weight groups at or near term corrected gestational age, and at 3-6 months of age.
Measured: 3 years
Non-invasive measurement of arterial stiffness: augmentation index
Augmentation index (%) will be measured using the Vicorder and compared between neonates of different gestational age and birth weight groups at or near term corrected gestational age, and at 3-6 months of age.
Measured: 3 years
Arterial structure measurements
The intima-media thickness of the carotid artery and abdominal aorta will be measured in micrometres (µm) using ultrasound at or near term corrected gestational age, and at 3-6 months of age. Gestational age and birth weight groups will be compared at each time point.
Measured: 3 years
Cardiac output measurements: comparison of neonatal and infant birth weight and gestational age cohorts
Cardiac output in L/min and ml/min/kg will be measured using echocardiography, the NICaS monitor and the Vicorder. Values obtained in different gestational age and birth weight groups will be compared at or near term corrected gestational age and at 3-6 months of age.
Measured: 3 years
Cardiac output measurements: comparison of devices
Cardiac output values in L/min and ml/min/kg obtained by each device (echocardiography, NICaS monitor and Vicorder) will be compared using correlation and Bland-Altman statistics.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start1 Dec 2020
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arterial StiffnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04720690
- Sponsor's protocol ID
- 20QC6217
- Acronym
- BAMBI
- Status last verified
- Jul 2024
- First submitted
- 8 Jan 2021
- Last updated
- 29 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioimpedence and Arterial Function Monitoring at Birth and in Infants: the BAMBI Study
- ClinicalTrials.gov ID
- NCT04720690
- Acronym / sponsor ID
- BAMBI / 20QC6217
- Conditions
- Arterial Stiffness, Fetal Growth Retardation, Small for Gestational Age at Delivery, Pre-Eclampsia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Imperial College Healthcare NHS TrustUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 22 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Appropriately grown for age infants | – | Device: Vicorder: pulse wave velocity, pulse wave analysis, stroke volume, cardiac output, Device: NICaS, Device: Echocardiography and ultrasound of arteries40 appropriately grown for gestational age (AGA) infants. 20 will be <32 weeks, and 20 will be ≥32 weeks gestational age at birth. |
| Small for gestational age infants | – | Device: Vicorder: pulse wave velocity, pulse wave analysis, stroke volume, cardiac output, Device: NICaS, Device: Echocardiography and ultrasound of arteries40 small for gestational age (SGA) infants. 20 will be <32 weeks, and 20 will be ≥32 weeks gestational age at birth. |
| Fetal growth restricted infants | – | Device: Vicorder: pulse wave velocity, pulse wave analysis, stroke volume, cardiac output, Device: NICaS, Device: Echocardiography and ultrasound of arteries40 fetal growth restricted (FGR) infants. 20 will be <32 weeks, and 20 will be ≥32 weeks gestational age at birth. |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- All term and preterm infants born at the Imperial College Healthcare NHS trust can be included to the study after parental consent.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vicorder: pulse wave velocity, pulse wave analysis, stroke volume, cardiac outputMeasurement of arterial stiffness and cardiac output | Device | Appropriately grown for age infants, Fetal growth restricted infants, Small for gestational age infants |
| NICaSMeasurement of cardiac output | Device | Appropriately grown for age infants, Fetal growth restricted infants, Small for gestational age infants |
| Echocardiography and ultrasound of arteriesMeasurement of cardiac output; measurement of intima-media thickness of arteries | Device | Appropriately grown for age infants, Fetal growth restricted infants, Small for gestational age infants |
Primary outcome
Feasibility of arterial and cardiac function measurements: the proportion of babies from whom study measurements are successfully obtained.
Time frame: 3 years
Feasibility of arterial and cardiac function measurements assessed through establishing from what proportion of babies the team is able to successfully obtain these measurements.
5 secondary outcomes
Non-invasive measurement of arterial stiffness: brachial-femoral pulse wave velocity
Time frame: 3 years
Non-invasive measurement of arterial stiffness: augmentation index
Time frame: 3 years
Arterial structure measurements
Time frame: 3 years
Cardiac output measurements: comparison of neonatal and infant birth weight and gestational age cohorts
Time frame: 3 years
Cardiac output measurements: comparison of devices
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2024.
- Individual participant dataSharing planned: No
Related trials for Arterial Stiffness
Active, not recruitingPhase 2
Effect of Equol Supplementation on Arterial Stiffness and Cognition in Healthy Volunteers
Arterial Stiffness, White Matter Lesions
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
RecruitingObservational study
Hypertension in Children and Young People at Risk of Autosomal Dominant Polycystic Kidney Disease
Autosomal Dominant Polycystic Kidney Disease (ADPKD
RecruitingObservational study
Kidney Stiffness Measured by Ultrasound in Patients With High Blood Pressure and Healthy Volunteers
Arterial Hypertension, Chronic Kidney Disease, Primary Aldosteronism
Recruiting
Passive Heat Therapy for Lowering Systolic Blood Pressure and Improving Vascular Function in Mid-life and Older Adults
Aging
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arterial Stiffness and Fetal Growth Retardation, run by Imperial College Healthcare NHS Trust at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jayanta Banerjee, MD (Res), FRCPCH (020 3313 7308, j.banerjee@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of arterial and cardiac function measurements: the proportion of babies from whom study measurements are successfully obtained. (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2024.