Non-invasive Continuous Cardiac Output Monitoring in Preterm Infants Study (NCT04064177) | Clinical Trial Compass
RecruitingNot Applicable
Non-invasive Continuous Cardiac Output Monitoring in Preterm Infants Study
United Kingdom148 participantsStarted 2019-10-24
Plain-language summary
This is an observational study in newborn term and preterm infants. The study will validate if non-invasive continuous cardiac output monitoring is feasible in newborn infants, if normative values can be constructed and what is the effect of fluid boluses and inotropes on cardiac output and peripheral vascular resistance.
Who can participate
Age range
1 Hour – 40 Weeks
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Healthy term infants in postnatal ward (within the first 72 hours of age)
* Term and Preterm infants (including those with FGR) admitted to the neonatal unit
* Written informed parental consent (prospective for postnatal ward and retrospective for babies admitted to the neonatal units)
Exclusion Criteria:
* Antenatal or postnatal diagnosis of severe congenital anomaly
* Infants with no realistic chance of survival
* Infants who are \>12 hours of age
* Infants with fragile skin not permitting skin probe placement
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Haemodynamic outcome comparison to echocardiography measured CO
Timeframe: 36 months
2
Changes in cardiac output
Timeframe: 36 months
Trial details
NCT IDNCT04064177
SponsorImperial College Healthcare NHS Trust
Sponsor typeOTHER
Study typeOBSERVATIONAL
Primary completion2024-12-31
Contact for this trial
Jayanta Banerjee Imperial College Healthcare NHS Trust