Monitoring heart and artery function in newborns and infants
Bioimpedence and Arterial Function Monitoring at Birth and in Infants: the BAMBI Study
This study is testing how heart and artery function differ in newborns and infants who are small for their age compared to those who are the right size, to see if we can spot any issues early on.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | N/A to 6 Months |
| Sex | All |
| Sponsor | Imperial College Healthcare NHS Trust Academic / other |
| Locations | 2 sites (London and 1 other locations) |
| Trial ID | NCT04720690 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the differences in cardiac and arterial structure and function between babies born appropriately grown for gestational age (AGA) and those who are small for gestational age (SGA). It aims to determine how early in life changes in arterial stiffness and heart function can be detected, particularly in SGA infants who may have experienced fetal growth restriction (FGR) or maternal pre-eclampsia. The study utilizes various monitoring techniques, including pulse wave velocity and echocardiography, to gather data on these infants during their first year of life.
Who should consider this trial
Good fit: Ideal candidates include healthy term and preterm infants, particularly those classified as SGA or with FGR, who are in the postnatal ward or neonatal unit.
Not a fit: Patients with complex congenital anomalies or genetic conditions, or those with no realistic chance of survival, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to early identification of cardiovascular risks in infants, allowing for timely interventions.
How similar studies have performed: While there is limited information on similar studies, the approach of monitoring arterial function in infants is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
London and 1 other locations
- Queen Charlotte's and Chelsea Hospital — London, United Kingdom (Recruiting)
- St Mary's Hospital — London, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Jayanta Banerjee, MD (Res), FRCPCH
- Email: j.banerjee@imperial.ac.uk
- Phone: 020 3313 7308
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.