Echocardiography of NewbornsNCT04307043
Study on the Geometric Parameters and Hemodynamic Reference Range of Neonatal Heart.
An observational study of Echocardiography of Newborns, run by Peking University Third Hospital at 1 site in China.
Trial summary
Perform bedside echocardiography on neonates (term and preterm infants) who were admitted to our neonatal department within 24 hours of birth, and establish a geometric reference range of neonatal cardiac ultrasound and explore the hemodynamic changes of early newborns. Read more about this study
- Who is it for?
- Ages Up to 12 weeksHealthy volunteers can take part
- Conditions the study is for
- Echocardiography of Newborns
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 5 Feb 2020to 31 Mar 2021
- How long will I take part?
- 12 Weeks
- 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 Up to 12 weeks
- All sexes
- Healthy volunteers accepted
- Child
Study population: Babies born in the obstetrics department of Peking University Third Hospital and admitted to the neonatal ward.
Who may be able to join
- 1. Infants with normal hearts (infants with small patent fora-men oval or small patent ductus arteriosus were not excluded).
- 2.Healthy preterm infant with no evidence of sepsis, renal failure. 3. Absence of other major congenital anomalies or syndromes 4. Prior written consent was obtained from the parents.
Who cannot join
- Infants with severe congenital malformations, either cardiac or non-cardiac.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Danfang Lu, MD, 15811091481, ldf0612@163.com
About this study
Official title: Prospective Study on Geometric Parameters and Hemodynamic Reference Range of Neonatal Heart.
Perform bedside echocardiography on neonates (term and preterm infants) who were admitted to our neonatal department within 24 hours of birth, and establish a geometric reference range of neonatal cardiac ultrasound and explore the hemodynamic changes of early newborns.
Bedside echocardiography were performed to measure the diameter of each heart cavity and large vessels, velocity of each valve and aorta, wall thickness, left ventricular systolic function, right heart Tei index, Tricuspid Annular Plane Systolic Excursion(TPASE) of term and preterm infants respectively on 0 day, 3d, 7d of life and postmenstrual age of 30 weeks, 32 weeks, 34 weeks and 36 weeks.
- Conditions
- Echocardiography of Newborns
- Keywords
- Echocardiography, Heart, Neonatal, Reference range
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| postnatal age | Not described | |
| General information and echocardiographic data | General information:(1)Record the gestational age, birth weight, length, delivery way, Apgar score, maternal pregnancy status, prenatal bleeding or not after admission.(2)PS use, ventilator mode, other illness and complications should be recorded during hospitalization. (3) Record the baby's heart rate, respiratory rate, blood pressure, body surface area on every check. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reference range of cardiac geometric parameters of preterm infants based on different gestational ages, weights, days of age and body surface area.
Measured: 0 day of life to PMA 36 weeks
Hemodynamic changes in full-term and preterm infants on 0~7days of life.
Measured: 0~7days of life
Secondary outcomes (1)
Reference range of cardiac geometric parameters of full-term infants based on different weights, days of age and body surface area.
Measured: 0~7days of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2020
- Study start5 Feb 2020
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Echocardiography of NewbornsStudies 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
- Prospective
- Enrolment
- 400 participants (estimated)
- Target duration
- 12 Weeks
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dan Fang Lu, Peking University Third Hospital
- Investigators
- Yunfeng Liu, MD, Study director, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04307043
- Sponsor's protocol ID
- bysypediatric2020-1
- Status last verified
- Mar 2020
- First submitted
- 11 Mar 2020
- Last updated
- 13 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Jain A, El-Khuffash AF, Kuipers BCW, Mohamed A, Connelly KA, McNamara PJ, Jankov RP, Mertens L. Left Ventricular Function in Healthy Term Neonates During the Transitional Period. J Pediatr. 2017 Mar;182:197-203.e2. doi: 10.1016/j.jpeds.2016.11.003. Epub 2016 Nov 28.
PubMed 27908646Abushaban L, Vel MT, Rathinasamy J, Sharma PN. Normal Reference Ranges for Cardiac Valve Annulus in Preterm Infants. Pediatr Cardiol. 2016 Jan;37(1):112-9. doi: 10.1007/s00246-015-1247-9. Epub 2015 Sep 1.
PubMed 26321355Abushaban L, Vel MT, Rathinasamy J, Sharma PN. Normal Reference Ranges for Pulmonary Artery Diameters in Preterm Infants. Pediatr Cardiol. 2017 Oct;38(7):1377-1384. doi: 10.1007/s00246-017-1673-y. Epub 2017 Jul 7.
PubMed 28687889Abushaban L, Mariappa TV, Rathinasamy J, Sharma PN. Normal reference ranges for aortic diameters in preterm infants. J Saudi Heart Assoc. 2018 Apr;30(2):86-94. doi: 10.1016/j.jsha.2017.09.003. Epub 2017 Oct 1.
PubMed 29910578Levy PT, Dioneda B, Holland MR, Sekarski TJ, Lee CK, Mathur A, Cade WT, Cahill AG, Hamvas A, Singh GK. Right ventricular function in preterm and term neonates: reference values for right ventricle areas and fractional area of change. J Am Soc Echocardiogr. 2015 May;28(5):559-69. doi: 10.1016/j.echo.2015.01.024. Epub 2015 Mar 7.
PubMed 25753503
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study on Geometric Parameters and Hemodynamic Reference Range of Neonatal Heart.
- ClinicalTrials.gov ID
- NCT04307043
- Acronym / sponsor ID
- bysypediatric2020-1
- Conditions
- Echocardiography of Newborns
- Keywords
- Echocardiography, Heart, Neonatal, Reference range
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 5 Feb 2020 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Mar 2021 (estimated)
- First posted
- 13 Mar 2020 (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.
Perform bedside echocardiography on neonates (term and preterm infants) who were admitted to our neonatal department within 24 hours of birth, and establish a geometric reference range of neonatal cardiac ultrasound and explore the hemodynamic changes of early newborns.
Bedside echocardiography were performed to measure the diameter of each heart cavity and large vessels, velocity of each valve and aorta, wall thickness, left ventricular systolic function, right heart Tei index, Tricuspid Annular Plane Systolic Excursion(TPASE) of term and preterm infants respectively on 0 day, 3d, 7d of life and postmenstrual age of 30 weeks, 32 weeks, 34 weeks and 36 weeks.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| postnatal age | – | – |
| General information and echocardiographic data | – | –General information:(1)Record the gestational age, birth weight, length, delivery way, Apgar score, maternal pregnancy status, prenatal bleeding or not after admission.(2)PS use, ventilator mode, other illness and complications should be recorded during hospitalization. (3) Record the baby's heart rate, respiratory rate, blood pressure, body surface area on every check. |
Who may qualify
- Ages
- Up to 12 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Babies born in the obstetrics department of Peking University Third Hospital and admitted to the neonatal ward.
Key inclusion criteria (2 listed)
- 1. Infants with normal hearts (infants with small patent fora-men oval or small patent ductus arteriosus were not excluded).
- 2.Healthy preterm infant with no evidence of sepsis, renal failure. 3. Absence of other major congenital anomalies or syndromes 4. Prior written consent was obtained from the parents.
Key exclusion criteria (1 listed)
- Infants with severe congenital malformations, either cardiac or non-cardiac.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Reference range of cardiac geometric parameters of preterm infants based on different gestational ages, weights, days of age and body surface area.
Time frame: 0 day of life to PMA 36 weeks
Hemodynamic changes in full-term and preterm infants on 0~7days of life.
Time frame: 0~7days of life
1 secondary outcome
Reference range of cardiac geometric parameters of full-term infants based on different weights, days of age and body surface area.
Time frame: 0~7days of life
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2020.
- Background: PubMed 27908646Jain A, El-Khuffash AF, Kuipers BCW, Mohamed A, Connelly KA, McNamara PJ, Jankov RP, Mertens L. Left Ventricular Function in Healthy Term Neonates During the Transitional Period. J Pediatr. 2017 Mar;182:197-203.e2. doi: 10.1016/j.jpeds.2016.11.003. Epub 2016 Nov 28.
- Background: PubMed 26321355Abushaban L, Vel MT, Rathinasamy J, Sharma PN. Normal Reference Ranges for Cardiac Valve Annulus in Preterm Infants. Pediatr Cardiol. 2016 Jan;37(1):112-9. doi: 10.1007/s00246-015-1247-9. Epub 2015 Sep 1.
- Background: PubMed 28687889Abushaban L, Vel MT, Rathinasamy J, Sharma PN. Normal Reference Ranges for Pulmonary Artery Diameters in Preterm Infants. Pediatr Cardiol. 2017 Oct;38(7):1377-1384. doi: 10.1007/s00246-017-1673-y. Epub 2017 Jul 7.
- Background: PubMed 29910578Abushaban L, Mariappa TV, Rathinasamy J, Sharma PN. Normal reference ranges for aortic diameters in preterm infants. J Saudi Heart Assoc. 2018 Apr;30(2):86-94. doi: 10.1016/j.jsha.2017.09.003. Epub 2017 Oct 1.
- Results publication: PubMed 25753503Levy PT, Dioneda B, Holland MR, Sekarski TJ, Lee CK, Mathur A, Cade WT, Cahill AG, Hamvas A, Singh GK. Right ventricular function in preterm and term neonates: reference values for right ventricle areas and fractional area of change. J Am Soc Echocardiogr. 2015 May;28(5):559-69. doi: 10.1016/j.echo.2015.01.024. Epub 2015 Mar 7.
- Individual participant dataSharing planned: Undecided
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.
Yunfeng Liu, MD study director
Peking University Third Hospital
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 Echocardiography of Newborns, run by Peking University Third Hospital at 1 site in China.
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 1 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 13 Mar 2020. 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 China. 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 Danfang LU, MD (15811091481, ldf0612@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reference range of cardiac geometric parameters of preterm infants based on different gestational ages, weights, days of age and body surface area. (time frame: 0 day of life to PMA 36 weeks). The study lists 2 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 NCT04307043, which also lists 5 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 13 Mar 2020; AzTrials last refreshed its copy on 28 Oct 2026.