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Bioimpedence and Arterial Function Monitoring at Birth and in Infants

NCT04720690 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2024-07-29

No results posted yet for this study

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.

Conditions

  • Arterial Stiffness
  • Fetal Growth Retardation
  • Small for Gestational Age at Delivery
  • Pre-Eclampsia

Interventions

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

Sponsors & Collaborators

  • Imperial College Healthcare NHS Trust

    lead OTHER

Eligibility

Max Age
6 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-12-01
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04720690 on ClinicalTrials.gov