Non-invasive Continuous Cardiac Output Monitoring in Preterm Infants Study

NCT04064177 | Recruiting

• 1 other identifier: 19QC5170
• Study Type: observational
• Target: 148
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Output, Low; Cardiac Output, High; Blood Pressure

Keywords

Blood Pressure

Outcome Measures

Primary Outcomes (2)

• Haemodynamic outcome comparison to echocardiography measured CO

  Non-invasive continuous Cardiac Output (CO) measurement (mls/kg/min) during the first month of life in comparison to echocardiography measured CO (mls/kg/min)

  36 months

• Changes in cardiac output

  Changes in cardiac output (CO) measurement (mls/kg/min) in relation to neonatal intervention

  36 months

Secondary Outcomes (1)

• Changes in clinical outcome - Survival at discharge

  36 months

Study Arms (2)

Babies (24-42 weeks)

All babies born between 24 and 42 weeks

Device: NICAS cardiac output monitor

Preterm infants

Preterm infants with fetal growth restriction

Device: NICAS cardiac output monitor

Interventions

NICAS cardiac output monitor DEVICE

Non-invasive continuous cardiac output monitoring device using total body bioimpedance.

Babies (24-42 weeks); Preterm infants

Eligibility Criteria

• Age: 1 Hour - 40 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

All term and preterm infants (24-42 weeks of gestational age) for the validation study and preterm infants with fetal growth restriction for the longitudinal study.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College Healthcare NHS Trust: lead

Study Sites (1)

Imperial College Healthcare NHS Trust

London, United Kingdom

RECRUITING

Related Publications (1)

• Banerjee J, Khatib N, Mansfield RC, Sathiyamurthy S, Kariholu U, Lees C. Continuous non-invasive measurement of cardiac output in neonatal intensive care using regional impedance cardiography: a prospective observational study. Arch Dis Child Fetal Neonatal Ed. 2024 Jun 19;109(4):450-455. doi: 10.1136/archdischild-2023-325941.

  PMID: 38123965 DERIVED

MeSH Terms

Conditions

Cardiac Output, Low; Cardiac Output, High

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jayanta Banerjee

  Neonatal consultant

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jayanta Banerjee Imperial College Healthcare NHS Trust

CONTACT

02033137308; jayanta.banerjee@nhs.net

Sundar Sathiyamurthy Imperial College Healthcare NHS Trust

CONTACT

02033137308; s.sathiyamurthy@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2019
• First Posted: August 21, 2019
• Study Start: October 24, 2019
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: July 29, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)