Bioimpedence and Arterial Function Monitoring at Birth and in Infants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-01

Study Completion Date

2024-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Appropriately grown for age infants

40 appropriately grown for gestational age (AGA) infants. 20 will be \<32 weeks, and 20 will be ≥32 weeks gestational age at birth.

Vicorder: pulse wave velocity, pulse wave analysis, stroke volume, cardiac output

Intervention Type DEVICE

Measurement of arterial stiffness and cardiac output

NICaS

Intervention Type DEVICE

Measurement of cardiac output

Echocardiography and ultrasound of arteries

Intervention Type DEVICE

Measurement of cardiac output; measurement of intima-media thickness of arteries

Small for gestational age infants

40 small for gestational age (SGA) infants. 20 will be \<32 weeks, and 20 will be ≥32 weeks gestational age at birth.

Vicorder: pulse wave velocity, pulse wave analysis, stroke volume, cardiac output

Intervention Type DEVICE

Measurement of arterial stiffness and cardiac output

NICaS

Intervention Type DEVICE

Measurement of cardiac output

Echocardiography and ultrasound of arteries

Intervention Type DEVICE

Measurement of cardiac output; measurement of intima-media thickness of arteries

Fetal growth restricted infants

40 fetal growth restricted (FGR) infants. 20 will be \<32 weeks, and 20 will be ≥32 weeks gestational age at birth.

Vicorder: pulse wave velocity, pulse wave analysis, stroke volume, cardiac output

Intervention Type DEVICE

Measurement of arterial stiffness and cardiac output

NICaS

Intervention Type DEVICE

Measurement of cardiac output

Echocardiography and ultrasound of arteries

Intervention Type DEVICE

Measurement of cardiac output; measurement of intima-media thickness of arteries

Interventions

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Vicorder: pulse wave velocity, pulse wave analysis, stroke volume, cardiac output

Measurement of arterial stiffness and cardiac output

Intervention Type DEVICE

NICaS

Measurement of cardiac output

Intervention Type DEVICE

Echocardiography and ultrasound of arteries

Measurement of cardiac output; measurement of intima-media thickness of arteries

Intervention Type DEVICE

Eligibility Criteria

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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

Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes