RecruitingOBSERVATIONAL

Bioimpedence and Arterial Function Monitoring at Birth and in Infants

This study will explore how the hearts and arteries (blood vessels) of newborn babies change and develop during their first year of life. We are especially interested in babies who were born smaller than expected for their age. These babies may be at higher risk of heart problems later in life, and we want to find out how early these changes can be spotted. The study will also test new ways of measuring heart health in babies using special devices. We hope to better understand how babies' hearts and arteries work, so we can identify any early signs of problems and potentially help them stay healthier as they grow.

At a glance

Status

Recruiting

Sponsor

Imperial College Healthcare NHS Trust

Enrolment target

120

Start

01 Dec 2020

Estimated completion

31 Dec 2024

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

What is this study about?

Imagine your heart and blood vessels as a special plumbing system that carries blood around your body. This study wants to understand how this system develops in babies, especially during their first year of life. We know that some babies are born smaller than expected, and these babies might have a higher chance of developing heart and blood vessel problems when they are older. This study aims to find out if we can see any early signs of these changes in their hearts and blood vessels right after birth.

We will be looking at two main things: the 'pipes' (arteries) and the 'pump' (heart). We want to understand if babies born smaller have different development in these areas compared to babies born at a healthy size. We'll also consider if other factors, like whether the mother had a condition called pre-eclampsia during pregnancy, affect these developments. Half of the babies in the study will be born before 32 weeks, and the other half will be born at or after 32 weeks, so we can see if being born early also makes a difference.

To do this, we'll use some special equipment that can measure how flexible the arteries are and how well the heart is pumping. We're also testing a new device called the Vicorder to see if it's a good way to measure these things in very young babies. By doing this, we hope to gain a much better understanding of baby heart health, which could help doctors in the future to identify babies who might need extra care.

Key takeaways

The study explores heart and artery development in babies.
It focuses on babies born smaller than expected.
Measurements are safe, gentle, and non-invasive.
The aim is to improve future understanding of baby heart health.
Parents can withdraw their baby from the study at any time.

Who may be eligible?

To be part of this study, babies need to meet certain conditions. We are looking for healthy babies who are full-term (born around 40 weeks) or premature (born earlier than 37 weeks). This includes babies who might have been smaller than expected for their gestational age. For all babies, their parents must give written permission for them to take part.

However, some babies cannot join the study. This includes babies who have serious birth defects, genetic conditions, or if they have very fragile skin that might get hurt by the equipment. Also, if a baby is very unwell and doctors don't believe they have a good chance of surviving, they won't be able to participate. If parents don't speak English and we can't arrange for a translator due to hospital demands, their baby also can't join the study.

Quick self-check

Is my baby a newborn or up to 6 months old?
Is my baby otherwise generally healthy?
Do we understand English well enough to understand the study information?
Does my baby NOT have a serious genetic condition or birth defect?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If your baby takes part in this study, they will have measurements taken shortly after birth, while they are still in hospital, and then again when they are between 3 and 6 months old. All these measurements are completely safe and do not involve any needles or medication. We will use special devices on their skin, similar to a blood pressure cuff, to gently check their heart and blood vessels. An ultrasound scan, just like the ones used during pregnancy, will also be used to look at their arteries. Each set of measurements will take a short amount of time, and you will be with your baby throughout. The total duration of the study for your baby will be up to about 6 months.

Potential risks and benefits

Taking part in this study won't directly improve your baby's health, but the information we gather could help many other babies in the future by improving our understanding of child heart health. The procedures are very safe, non-invasive, and won't cause any pain or discomfort to your baby. The main 'risk' is simply the time it takes for the measurements to be done. You are free to withdraw your baby from the study at any time, for any reason, without it affecting your baby's medical care.

Locations (2)

Queen Charlotte's and Chelsea Hospital
London, United Kingdom· Recruiting
St Mary's Hospital
London, United Kingdom· Recruiting

Common questions

What is 'arterial stiffness'?

Arterial stiffness means how flexible your blood vessels are. More flexible vessels are generally healthier.

What does 'SGA' mean?

SGA stands for 'Small for Gestational Age', meaning a baby was born smaller than typically expected for their age in the womb.

Will my baby need any injections?

No, all the measurements in this study are non-invasive and do not involve any needles or injections.

How long will each measurement session take?

Each session to take measurements will be quite short, and you will be with your baby the whole time.

What is 'pre-eclampsia'?

Pre-eclampsia is a condition that can happen during pregnancy, causing high blood pressure and other issues for the mother.

How to find out more

Jayanta Banerjee, MD (Res), FRCPCH

j.banerjee@imperial.ac.uk 020 3313 7308 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.