Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Bioimpedence and Arterial Function Monitoring at Birth and in Infants (BAMBI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04720690
Recruitment Status : Recruiting
First Posted : January 22, 2021
Last Update Posted : January 22, 2021
Sponsor:
Information provided by (Responsible Party):
Imperial College Healthcare NHS Trust

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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 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.

Condition or disease Intervention/treatment
Arterial Stiffness Fetal Growth Retardation Small for Gestational Age at Delivery Pre-Eclampsia Device: Vicorder: pulse wave velocity, pulse wave analysis, stroke volume, cardiac output Device: NICaS Device: Echocardiography and ultrasound of arteries

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Bioimpedence and Arterial Function Monitoring at Birth and in Infants: the BAMBI Study
Actual Study Start Date : December 1, 2020
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
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.
 Device: Vicorder: pulse wave velocity, pulse wave analysis, stroke volume, cardiac output
Measurement of arterial stiffness and cardiac output

Device: NICaS
Measurement of cardiac output

Device: Echocardiography and ultrasound of arteries
Measurement of cardiac output; measurement of intima-media thickness 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.
 Device: Vicorder: pulse wave velocity, pulse wave analysis, stroke volume, cardiac output
Measurement of arterial stiffness and cardiac output

Device: NICaS
Measurement of cardiac output

Device: Echocardiography and ultrasound of arteries
Measurement of cardiac output; measurement of intima-media thickness 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.
 Device: Vicorder: pulse wave velocity, pulse wave analysis, stroke volume, cardiac output
Measurement of arterial stiffness and cardiac output

Device: NICaS
Measurement of cardiac output

Device: Echocardiography and ultrasound of arteries
Measurement of cardiac output; measurement of intima-media thickness of arteries


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Non-invasive measurement of arterial stiffness: brachial-femoral pulse wave velocity [ Time Frame: 3 years ]
    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.

  2. Non-invasive measurement of arterial stiffness: augmentation index [ Time Frame: 3 years ]
    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.

  3. Arterial structure measurements [ Time Frame: 3 years ]
    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.

  4. Cardiac output measurements: comparison of neonatal and infant birth weight and gestational age cohorts [ Time Frame: 3 years ]
    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.

  5. Cardiac output measurements: comparison of devices [ Time Frame: 3 years ]
    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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All term and preterm infants born at the Imperial College Healthcare NHS trust can be included to the study after parental consent.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04720690


Contacts
Layout table for location contacts
Contact: Jayanta Banerjee, MD (Res), FRCPCH 020 3313 7308 j.banerjee@imperial.ac.uk

Locations
Layout table for location information
United Kingdom
Queen Charlotte's and Chelsea Hospital Recruiting
London, United Kingdom, W120HS
Contact: Jayanta Banerjee, MD (Res), FRCPCH    020 3313 7308    j.banerjee@imperial.ac.uk   
St Mary's Hospital Recruiting
London, United Kingdom, W21NY
Contact: Jayanta Banerjee, MD (Res), FRCPCH    020 3313 7308    j.banerjee@imperial.ac.uk   
Sponsors and Collaborators
Imperial College Healthcare NHS Trust
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Imperial College Healthcare NHS Trust
ClinicalTrials.gov Identifier: NCT04720690    
Other Study ID Numbers: 20QC6217
First Posted: January 22, 2021    Key Record Dates
Last Update Posted: January 22, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Eclampsia
Pre-Eclampsia
Fetal Growth Retardation
Hypertension, Pregnancy-Induced
 Pregnancy Complications
Fetal Diseases
Growth Disorders
Pathologic Processes