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Non-invasive Continuous Cardiac Output Monitoring in Preterm Infants Study

This research is focused on a new, gentle way to check how effectively a baby's heart pumps blood. This special monitor doesn't use any needles and aims to give doctors a clearer picture of a baby's heart health. The study will look at whether this new monitoring method actually works well for newborn babies, including those born early or those who are unwell. Researchers also want to create normal heart function guidelines for babies and explore how common treatments like extra fluids or certain medicines affect how the heart pumps blood. Ultimately, this information could help doctors make better decisions about how to care for very young babies.

At a glance

Status
Recruiting
Sponsor
Imperial College Healthcare NHS Trust
Enrolment target
148
Start
24 Oct 2019
Estimated completion
31 Dec 2024

What is this study about?

Imagine your baby is in the hospital, and doctors need to know how well their heart is working. Traditionally, some methods can be a bit invasive. This study is exploring a new, much gentler way to check a baby's heart function, specifically how much blood it pumps out – something called 'cardiac output'. This new monitor is non-invasive, meaning it doesn't involve any needles or cuts, making it much more comfortable for the tiny patients.

The main goal is to see if this new non-invasive monitor gives accurate and useful information. If it does, it could become a standard tool in neonatal intensive care units (NICUs) across the UK. The researchers also want to create a clear understanding of what 'normal' heart pumping looks like in healthy newborns and how it might differ in babies born early or with certain health issues. This information is crucial because babies, especially those who are sick or premature, can have very different needs.

Another important aspect of the study is to understand how common treatments affect a baby's heart. For example, doctors often give babies extra fluids or special medicines to help their hearts. This research will look at how these interventions change the amount of blood the heart pumps and the resistance in their tiny blood vessels. By understanding these effects better, doctors can fine-tune treatments to give each baby the best possible care.

Key takeaways

  • It's exploring a new, gentle way to check baby heart function.
  • No needles or invasive procedures are involved with the monitor.
  • It aims to create 'normal' heart function guidelines for babies.
  • The study observes how standard treatments affect a baby's heart.
  • Findings could improve care for babies in the future.

Who may be eligible?

This study is looking for a few different groups of babies to take part. This includes healthy babies who are in the postnatal ward, usually within their first three days of life. It also includes babies admitted to the neonatal unit, whether they were born at full term or prematurely.

For babies to join the study, their parents will need to give written permission. This permission usually needs to be given beforehand for healthy babies, and possibly after admission for those in the neonatal unit.

However, some babies cannot take part. This includes babies who have been diagnosed with a serious birth defect before or after birth, or those who sadly have no real chance of survival. Babies older than 12 hours cannot join the healthy baby group, and those with very delicate skin that wouldn't allow the monitor to be placed also wouldn't be able to participate.

Quick self-check
  • Is your baby a healthy newborn in the postnatal ward (under 72 hours old)?
  • Is your baby admitted to a neonatal unit (term or preterm)?
  • Are you able to give written permission for your baby to join?
  • Does your baby not have a severe birth defect?
  • Is your baby's skin healthy enough for the monitor to be placed?

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, it's an observational study, which means doctors will simply observe and measure your baby using the new monitor. Your baby won't be given any new or experimental medicines as part of the study itself. The monitoring device will be gently placed on your baby's skin. The study will track heart function for a period, and researchers will gather information on how your baby responds to any routine treatments they might need, such as fluids or heart-support medicines. There are no specific study visits or follow-up appointments required beyond your baby's standard care. The study is planned to last for three years in total, across many babies.

Potential risks and benefits

The potential benefits of participation include helping doctors gain a better understanding of baby heart health, which could lead to improved care for future babies. Since the monitor sits gently on the skin, the main risk is very minor skin irritation where it's placed. Your baby will continue to receive their usual medical care, and this study will not change those treatments. You are free to withdraw your baby from the study at any time without affecting their medical care.

Locations (1)

  • Imperial College Healthcare NHS Trust
    London, United Kingdom· Recruiting

Common questions

What is 'cardiac output'?

Cardiac output is simply the amount of blood your baby's heart pumps out each minute. It's a key sign of how well the heart is working.

Is the new monitor safe for my baby?

Yes, this monitor is non-invasive, meaning it doesn't involve needles or discomfort. It sits gently on the skin, similar to other monitors used in hospitals.

Will my baby get extra medicines?

No, your baby will only receive their usual, necessary medical treatments decided by their doctors. The study is about observing how this new monitor works with those existing treatments.

How long will my baby be monitored?

The study aims to monitor babies continuously where appropriate to see how their heart function changes over time and with treatment, but this will be part of their routine care.

What is a 'preterm infant'?

A preterm infant is a baby born too early, before 37 weeks of pregnancy.

How to find out more

Jayanta Banerjee Imperial College Healthcare NHS Trust

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

Interested in taking part?

Register your interest

Share your details and the research team for "Non-invasive Continuous Cardiac Output Monitoring in Preterm…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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