Very Low Birth Weight InfantNCT05961657
USCOM Parameters in Preterm Infants: Reference Ranges
An observational study of Very Low Birth Weight Infant and Very Preterm Maturity of Infant, run by Fondazione IRCCS San Gerardo dei Tintori at 1 site in Italy.
Trial summary
The goal of this observational study is to learn about the feasibility of hemodynamic measurement by the UltraSonic Cardiac Output Monitor (USCOM) in very preterm or very-low-birth-weight infants. Read more about this study
- Who is it for?
- Ages 2 to 16 days
- Conditions the study is for
- Very Low Birth Weight Infant, Very Preterm Maturity of Infant
- What is being tested?
- Hemodynamic measurements by USCOM
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 6 Jul 2023to 1 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 16 days
- All sexes
- No healthy volunteers
- Child
Study population: We include very preterm and/or very low birth weight infants without heart disease as assessed by echocardiography, who are considered hemodynamically stable by the attending physician and do not require drugs that might affect the cardiocirculatory function (e.g., inotropes).
Who may be able to join
- gestational age at birth below 32 weeks and/or
- birth weight (BW) below 1500 g
Who cannot join
- congenital heart diseases,
- hemodynamic instability requiring drugs that affect hemodynamics (e.g., inotropes)
Trial locations and contacts
1 site in 1 country.
Emanuela Zannin, PhD contact
Italy1 site, 1 recruiting
- Recruiting
Fondazione IRCCS San Gerardo dei Tintori
Monza, Monza E Brianza, 20900
Danial Donu, MD, +39039233 ext. 9173, danieladoni9@gmail.com
Emanuela Zannin, PhD, emanuela.zannin@gmail.com
About this study
Official title: Hemodynamic Evaluation in Preterm Babies Using UltraSonic Cardiac Output Monitor (USCOM)
The goal of this observational study is to learn about the feasibility of hemodynamic measurement by the UltraSonic Cardiac Output Monitor (USCOM) in very preterm or very-low-birth-weight infants. The main questions it aims to answer are: 1) establishing reference ranges for USCOM parameters in this specific population, 2) assessing the effect of patients' characteristics and other possible confounders on USCOM parameters, and 3) evaluating the short-term repeatability of the measurement. Participants will receive USCOM measurements on 3, 7, and 14 postnatal days.
- Being tested
- Hemodynamic measurements by USCOM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemodynamic measurements by USCOMDiagnostic test
We will measure cardiac output, cardiac index, and systemic vascular resistance index on 3, 7, and 14 postnatal days using the UltraSonic Cardiac Output Monitor.
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac Output at 3 days
Cardiac Output measured by the USCOM system, normalized by body weight and expressed in ml/kg/min
Measured: 3 ± 1 days of life
Cardiac Output at 7 days
Cardiac Output measured by the USCOM system, normalized by body weight and expressed in ml/kg/min
Measured: 7 ± 2 days of life
Cardiac Output at 14 days
Cardiac Output measured by the USCOM system, normalized by body weight and expressed in ml/kg/min
Measured: 14 ± 2 days of life
Cardiac Index at 3 days
Cardiac Output measured by the USCOM system normalized by body surface and expressed in L/min/m2
Measured: 3 ± 1 days of life
Cardiac Index at 7 days
Cardiac Output measured by the USCOM system normalized by body surface and expressed in L/min/m2
Measured: 7 ± 2 days of life
Cardiac Index at 14 days
Cardiac Output measured by the USCOM system normalized by body surface and expressed in L/min/m2
Measured: 14 ± 2 days of life
Systemic Vascular Resistance Index at 3 days
Systemic Vascular Resistance measured by the USCOM system normalized by body surface and expressed in d*s*cm-5/m2
Measured: 3 ± 1 days of life
Systemic Vascular Resistance Index at 7 days
Systemic Vascular Resistance measured by the USCOM system normalized by body surface and expressed in d*s*cm-5/m2
Measured: 7 ± 2 days of life
Systemic Vascular Resistance Index at 14 days
Systemic Vascular Resistance measured by the USCOM system normalized by body surface and expressed in d*s*cm-5/m2
Measured: 14 ± 2 days of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start6 Jul 2023
- Primary completion9 Aug 2023 (estimated)
- Study completion1 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Very Low Birth Weight InfantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS San Gerardo dei Tintori
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniela Doni, Fondazione IRCCS San Gerardo dei Tintori
- Investigators
- Daniela Doni, MD, Principal investigator, Fondazione IRCCS San Gerardo dei Tintori
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05961657
- Sponsor's protocol ID
- EmoNeo
- Status last verified
- Jul 2023
- First submitted
- 18 Jul 2023
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Doni D, Nucera S, Rigotti C, Arosio E, Cavalleri V, Ronconi M, Ventura ML, Fedeli T. Evaluation of hemodynamics in healthy term neonates using ultrasonic cardiac output monitor. Ital J Pediatr. 2020 Aug 5;46(1):112. doi: 10.1186/s13052-020-00872-x.
PubMed 32758264Patel N, Dodsworth M, Mills JF. Cardiac output measurement in newborn infants using the ultrasonic cardiac output monitor: an assessment of agreement with conventional echocardiography, repeatability and new user experience. Arch Dis Child Fetal Neonatal Ed. 2011 May;96(3):F206-11. doi: 10.1136/adc.2009.170704. Epub 2010 Jul 6.
PubMed 20605971Fraga MV, Dysart KC, Rintoul N, Chaudhary AS, Ratcliffe SJ, Fedec A, Kren S, Cohen MS, Kirpalani H. Cardiac Output Measurement Using the Ultrasonic Cardiac Output Monitor: A Validation Study in Newborn Infants. Neonatology. 2019;116(3):260-268. doi: 10.1159/000501005. Epub 2019 Jul 19.
PubMed 31326967He SR, Zhang C, Liu YM, Sun YX, Zhuang J, Chen JM, Madigan VM, Smith BE, Sun X. Accuracy of the ultrasonic cardiac output monitor in healthy term neonates during postnatal circulatory adaptation. Chin Med J (Engl). 2011 Aug;124(15):2284-9.
PubMed 21933558
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Evaluation in Preterm Babies Using UltraSonic Cardiac Output Monitor (USCOM)
- ClinicalTrials.gov ID
- NCT05961657
- Acronym / sponsor ID
- EmoNeo
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Fondazione IRCCS San Gerardo dei TintoriUniversity, hospital or other
- Study start
- 6 Jul 2023 (actual)
- Primary completion
- 9 Aug 2023 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 27 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to learn about the feasibility of hemodynamic measurement by the UltraSonic Cardiac Output Monitor (USCOM) in very preterm or very-low-birth-weight infants. The main questions it aims to answer are: 1) establishing reference ranges for USCOM parameters in this specific population, 2) assessing the effect of patients' characteristics and other possible confounders on USCOM parameters, and 3) evaluating the short-term repeatability of the measurement. Participants will receive USCOM measurements on 3, 7, and 14 postnatal days.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 2 to 16 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- We include very preterm and/or very low birth weight infants without heart disease as assessed by echocardiography, who are considered hemodynamically stable by the attending physician and do not require drugs that might affect the cardiocirculatory function (e.g., inotropes).
Key inclusion criteria (2 listed)
- gestational age at birth below 32 weeks and/or
- birth weight (BW) below 1500 g
Key exclusion criteria (2 listed)
- congenital heart diseases,
- hemodynamic instability requiring drugs that affect hemodynamics (e.g., inotropes)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hemodynamic measurements by USCOMWe will measure cardiac output, cardiac index, and systemic vascular resistance index on 3, 7, and 14 postnatal days using the UltraSonic Cardiac Output Monitor. | Diagnostic test | – |
Primary outcome
Cardiac Output at 3 days
Time frame: 3 ± 1 days of life
Cardiac Output measured by the USCOM system, normalized by body weight and expressed in ml/kg/min
Cardiac Output at 7 days
Time frame: 7 ± 2 days of life
Cardiac Output measured by the USCOM system, normalized by body weight and expressed in ml/kg/min
Cardiac Output at 14 days
Time frame: 14 ± 2 days of life
Cardiac Output measured by the USCOM system, normalized by body weight and expressed in ml/kg/min
Cardiac Index at 3 days
Time frame: 3 ± 1 days of life
Cardiac Output measured by the USCOM system normalized by body surface and expressed in L/min/m2
Cardiac Index at 7 days
Time frame: 7 ± 2 days of life
Cardiac Output measured by the USCOM system normalized by body surface and expressed in L/min/m2
Cardiac Index at 14 days
Time frame: 14 ± 2 days of life
Cardiac Output measured by the USCOM system normalized by body surface and expressed in L/min/m2
Systemic Vascular Resistance Index at 3 days
Time frame: 3 ± 1 days of life
Systemic Vascular Resistance measured by the USCOM system normalized by body surface and expressed in d*s*cm-5/m2
Systemic Vascular Resistance Index at 7 days
Time frame: 7 ± 2 days of life
Systemic Vascular Resistance measured by the USCOM system normalized by body surface and expressed in d*s*cm-5/m2
Systemic Vascular Resistance Index at 14 days
Time frame: 14 ± 2 days of life
Systemic Vascular Resistance measured by the USCOM system normalized by body surface and expressed in d*s*cm-5/m2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Background: PubMed 32758264Doni D, Nucera S, Rigotti C, Arosio E, Cavalleri V, Ronconi M, Ventura ML, Fedeli T. Evaluation of hemodynamics in healthy term neonates using ultrasonic cardiac output monitor. Ital J Pediatr. 2020 Aug 5;46(1):112. doi: 10.1186/s13052-020-00872-x.
- Background: PubMed 20605971Patel N, Dodsworth M, Mills JF. Cardiac output measurement in newborn infants using the ultrasonic cardiac output monitor: an assessment of agreement with conventional echocardiography, repeatability and new user experience. Arch Dis Child Fetal Neonatal Ed. 2011 May;96(3):F206-11. doi: 10.1136/adc.2009.170704. Epub 2010 Jul 6.
- Background: PubMed 31326967Fraga MV, Dysart KC, Rintoul N, Chaudhary AS, Ratcliffe SJ, Fedec A, Kren S, Cohen MS, Kirpalani H. Cardiac Output Measurement Using the Ultrasonic Cardiac Output Monitor: A Validation Study in Newborn Infants. Neonatology. 2019;116(3):260-268. doi: 10.1159/000501005. Epub 2019 Jul 19.
- Background: PubMed 21933558He SR, Zhang C, Liu YM, Sun YX, Zhuang J, Chen JM, Madigan VM, Smith BE, Sun X. Accuracy of the ultrasonic cardiac output monitor in healthy term neonates during postnatal circulatory adaptation. Chin Med J (Engl). 2011 Aug;124(15):2284-9.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emanuela Zannin, PhD contact
Daniela Doni, MD principal investigator
Fondazione IRCCS San Gerardo dei Tintori
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Very Low Birth Weight Infant and Very Preterm Maturity of Infant, run by Fondazione IRCCS San Gerardo dei Tintori at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniela Doni, MD (+39039233 ext. 9173, danieladoni9@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac Output at 3 days (time frame: 3 ± 1 days of life). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05961657, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.