Clinical trial NCT04720690: Bioimpedence and Arterial Function Monitoring at Birth and in Infants
Official title: Bioimpedence and Arterial Function Monitoring at Birth and in Infants: the BAMBI Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Arterial Stiffness
Fetal Growth Retardation
Small for Gestational Age at Delivery
Pre-Eclampsia
Lead sponsor: Imperial College Healthcare NHS Trust
Sponsor class: OTHER
First posted: 2021-01-22
Enrollment: 120
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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

Primary outcomes:
measure: Feasibility of arterial and cardiac function measurements: the proportion of babies from whom study measurements are successfully obtained.
timeFrame: 3 years
Secondary outcomes:
measure: Non-invasive measurement of arterial stiffness: brachial-femoral pulse wave velocity
timeFrame: 3 years
measure: Non-invasive measurement of arterial stiffness: augmentation index
timeFrame: 3 years
measure: Arterial structure measurements
timeFrame: 3 years
measure: Cardiac output measurements: comparison of neonatal and infant birth weight and gestational age cohorts
timeFrame: 3 years
measure: Cardiac output measurements: comparison of devices
timeFrame: 3 years
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Queen Charlotte's and Chelsea Hospital
city: London
country: United Kingdom
facility: St Mary's Hospital
Study officials:
References: