An observational study in Arterial Stiffness, Fetal Growth Retardation and Small for Gestational Age at Delivery, sponsored by Imperial College Healthcare NHS Trust. Recruiting at 2 sites in United Kingdom. Open to participants aged Up to 6 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-29.
Sponsored by Imperial College Healthcare NHS Trust · Observational
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.
262 studies on the registry are indexed under Fetal Growth Retardation; 69 are open to participants now.
This study's planned enrollment of 120 is below the median of 200 across 145 observational studies indexed under Fetal Growth Retardation.
Browse Fetal Growth Retardation studies →Imperial College Healthcare NHS Trust is the lead sponsor of 80 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All term and preterm infants born at the Imperial College Healthcare NHS trust can be included to the study after parental consent.
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Exclusion Criteria:
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 · Device: NICaS · Device: Echocardiography and ultrasound of arteries
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 · Device: NICaS · Device: Echocardiography and ultrasound of arteries
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 · Device: NICaS · Device: Echocardiography and ultrasound of arteries
Measurement of arterial stiffness and cardiac output
Measurement of cardiac output
Measurement of cardiac output; measurement of intima-media thickness of arteries
Feasibility of arterial and cardiac function measurements: the proportion of babies from whom study measurements are successfully obtained.
Feasibility of arterial and cardiac function measurements assessed through establishing from what proportion of babies the team is able to successfully obtain these measurements.
Time frame: 3 years
Non-invasive measurement of arterial stiffness: brachial-femoral pulse wave velocity
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.
Time frame: 3 years
Non-invasive measurement of arterial stiffness: augmentation index
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.
Time frame: 3 years
Arterial structure measurements
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.
Time frame: 3 years
Cardiac output measurements: comparison of neonatal and infant birth weight and gestational age cohorts
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.
Time frame: 3 years
Cardiac output measurements: comparison of devices
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.
Time frame: 3 years
Plan to share: No
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Started Dec 2020 (actual). Primary completion is estimated for Dec 2024, 48 months after the start.
Of 72 non-industry observational studies under Fetal Growth Retardation, half reached primary completion within 52 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 170. This study's planned 48 months is close to that.
Counting every sponsor, half of 73 studies reached it within 52 months; a quarter within 24 and three quarters within 170.
How these figures are worked out, and which studies are left out of them.
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Imperial College Healthcare NHS Trust