Monitoring heart output in preterm infants
Non-invasive Continuous Cardiac Output Monitoring in Preterm Infants Study
Imperial College Healthcare NHS Trust · NCT04064177
This study is trying to see if a new non-invasive way to monitor heart output can help doctors better understand and treat preterm and term infants in neonatal intensive care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 148 (estimated) |
| Ages | 1 Hour to 40 Weeks |
| Sex | All |
| Sponsor | Imperial College Healthcare NHS Trust (other) |
| Locations | 1 site (London) |
| Trial ID | NCT04064177 on ClinicalTrials.gov |
What this trial studies
This observational study aims to validate the feasibility of non-invasive continuous cardiac output monitoring in newborn infants, particularly focusing on preterm and term infants in neonatal intensive care. Over a period of three years, the study will assess how interventions like fluid boluses and inotropes affect cardiac output and peripheral vascular resistance. The research will also seek to establish normative values for cardiac output in this vulnerable population, providing insights into cardiovascular assessment in neonatal care.
Who should consider this trial
Good fit: Ideal candidates include healthy term infants within the first 72 hours of age and term or preterm infants admitted to the neonatal unit.
Not a fit: Patients with severe congenital anomalies or those with no realistic chance of survival may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the monitoring and management of cardiovascular health in preterm infants, potentially improving outcomes.
How similar studies have performed: While the approach of non-invasive monitoring is gaining traction, this specific application in preterm infants is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
London
- Imperial College Healthcare NHS Trust — London, United Kingdom (RECRUITING)
Study contacts
- Principal investigator: Jayanta Banerjee — Neonatal consultant
- Study coordinator: Jayanta Banerjee Imperial College Healthcare NHS Trust
- Email: jayanta.banerjee@nhs.net
- Phone: 02033137308
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cardiac Output, Low, Cardiac Output, High, Blood Pressure