NCT04720690 Bioimpedence and Arterial Function Monitoring at Birth and in Infants
| NCT ID | NCT04720690 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Imperial College Healthcare NHS Trust |
| Condition | Arterial Stiffness |
| Study Type | OBSERVATIONAL |
| Enrollment | 120 participants |
| Start Date | 2020-12-01 |
| Primary Completion | 2024-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 120 participants in total. It began in 2020-12-01 with a primary completion date of 2024-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04720690 clinical trial?
This trial is open to participants of all sexes, up to 6 Months, studying Arterial Stiffness. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04720690 currently recruiting?
Yes, NCT04720690 is actively recruiting participants. Contact the research team at j.banerjee@imperial.ac.uk for enrollment information.
Where is the NCT04720690 trial being conducted?
This trial is being conducted at London, United Kingdom, London, United Kingdom.
Who is sponsoring the NCT04720690 clinical trial?
NCT04720690 is sponsored by Imperial College Healthcare NHS Trust. The trial plans to enroll 120 participants.