Bioimpedence and Arterial Function Monitoring at Birth and in Infants

NCT04720690 | Recruiting

• 1 other identifier: 20QC6217
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  3 years

Secondary Outcomes (5)

• Non-invasive measurement of arterial stiffness: brachial-femoral pulse wave velocity

  3 years

• Non-invasive measurement of arterial stiffness: augmentation index

  3 years

• Arterial structure measurements

  3 years

• Cardiac output measurements: comparison of neonatal and infant birth weight and gestational age cohorts

  3 years

• Cardiac output measurements: comparison of devices

  3 years

Study Arms (3)

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.

Device: Vicorder: pulse wave velocity, pulse wave analysis, stroke volume, cardiac output; Device: NICaS; Device: Echocardiography and ultrasound 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.

Device: Vicorder: pulse wave velocity, pulse wave analysis, stroke volume, cardiac output; Device: NICaS; Device: Echocardiography and ultrasound 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.

Device: Vicorder: pulse wave velocity, pulse wave analysis, stroke volume, cardiac output; Device: NICaS; Device: Echocardiography and ultrasound of arteries

Interventions

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

Measurement of arterial stiffness and cardiac output

Appropriately grown for age infants; Fetal growth restricted infants; Small for gestational age infants

NICaS DEVICE

Measurement of cardiac output

Appropriately grown for age infants; Fetal growth restricted infants; Small for gestational age infants

Echocardiography and ultrasound of arteries DEVICE

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

Appropriately grown for age infants; Fetal growth restricted infants; Small for gestational age infants

Eligibility Criteria

• Age: Up to 6 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College Healthcare NHS Trust: lead

Study Sites (2)

Queen Charlotte's and Chelsea Hospital

London, W120HS, United Kingdom

RECRUITING

St Mary's Hospital

London, W21NY, United Kingdom

RECRUITING

MeSH Terms

Conditions

Fetal Growth Retardation; Pre-Eclampsia

Interventions

Pulse Wave Analysis; Stroke Volume; Cardiac Output; Echocardiography

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hypertension, Pregnancy-Induced

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Heart Function Tests; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Cardiac Imaging Techniques; Diagnostic Imaging; Ultrasonography

Central Study Contacts

Jayanta Banerjee, MD (Res), FRCPCH

CONTACT

020 3313 7308; j.banerjee@imperial.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2021
• First Posted: January 22, 2021
• Study Start: December 1, 2020
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: July 29, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)