NCT04064177 Non-invasive Continuous Cardiac Output Monitoring in Preterm Infants Study
| NCT ID | NCT04064177 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Imperial College Healthcare NHS Trust |
| Condition | Cardiac Output, Low |
| Study Type | OBSERVATIONAL |
| Enrollment | 148 participants |
| Start Date | 2019-10-24 |
| Primary Completion | 2024-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 148 participants in total. It began in 2019-10-24 with a primary completion date of 2024-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
Jayanta Banerjee
PRINCIPAL INVESTIGATOR
Neonatal consultant
Frequently Asked Questions
Who can join the NCT04064177 clinical trial?
This trial is open to participants of all sexes, aged 1 Hour or older, up to 40 Weeks, studying Cardiac Output, Low. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04064177 currently recruiting?
Yes, NCT04064177 is actively recruiting participants. Contact the research team at jayanta.banerjee@nhs.net for enrollment information.
Where is the NCT04064177 trial being conducted?
This trial is being conducted at London, United Kingdom.
Who is sponsoring the NCT04064177 clinical trial?
NCT04064177 is sponsored by Imperial College Healthcare NHS Trust. The principal investigator is Jayanta Banerjee at Neonatal consultant. The trial plans to enroll 148 participants.