EchocardiographyNORRNENCT05462301
Normal Reference Range for Neonatal Echocardiography
An observational study of Echocardiography, run by Children's Hospital of Chongqing Medical University at 1 site in China.
Trial summary
Echocardiography is the main method of bedside examination of neonatal cardiac morphology, which can timely diagnose congenital heart disease and quantitatively assess its severity, but the diagnosis and evaluation process depends on the normal range of neonatal echocardiography.At present, there have been normal… Read more about this study
- Who is it for?
- Ages 1 day to 28 daysHealthy volunteers can take part
- Conditions the study is for
- Echocardiography
- How many people
- 1,500 participants
- Where
- 1 siteChina
- Study dates
- 15 Nov 2022to 30 Dec 2024
- 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 1 day to 28 days
- All sexes
- Healthy volunteers accepted
- Child
Study population: healthy neonates and preterm Infants
Who may be able to join
- Outpatient or inpatient neonate
- Gestational age > 30weeks and birthweight > 1250 grams
- Appropriate for gestational age
- Without perinatal asphyxia
- Without skin lesion on the left chest wall
- with family informed consent for neonatal echocardiography
Who cannot join
- specialist cardiac ultrasound suggests congenital heart disease;
- PDA with hemodynamic abnormalities, defined as: PDA > 1.5 mm (left-to-right shunt) and left atrial diameter/aortic root > 1.5 or the need for the use of inotropes;
- invasive mechanical ventilation therapy,
- non-invasive mechanical ventilation with FiO2 >0.3
- major anomalies
- blood culture-proven neonatal sepsis
Show all 11Show fewer
- persistent pulmonary hypertension
- renal failure
- necrotizing enterocolitis ≥ stage II
- post surgery
- Maternal history of severe anemia, or prenatal massive bleeding
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Children's Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400014
Wang Jianhui, 13678428167, wangjh805@126.com
About this study
Official title: Normal Reference Range for Neonatal Echocardiography: a Multi-center, Prospective Study
Echocardiography is the main method of bedside examination of neonatal cardiac morphology, which can timely diagnose congenital heart disease and quantitatively assess its severity, but the diagnosis and evaluation process depends on the normal range of neonatal echocardiography.At present, there have been normal reference standards for echocardiography in children and adults at home and abroad, but there is no uniform standard for echocardiographic parameters in newborns, especially premature infants.This study intends to carry out a national multicenter, prospective, observational study to establish the reference range of echocardiography at different time periods after birth in newborns, and stratified according to gestational age, birth weight and gender, to conduct a more accurate hemodynamic assessment of clinically critically ill newborns and guide the treatment of critically ill newborns in real time.
Read the detailed description
Neonatal goal-directed echocardiography (TNE) performed by neonatologists has been increasingly applied to hemodynamic assessment in the NICU to guide critical neonatal treatment in real time. There are many detection indexes of TNE, which are closely related to neonatal weight, birth weight, postnatal age, race and other factors. Therefore, establishing neonatal echocardiographic reference ranges is essential for the development of TNE. At present, there have been normal reference standards for echocardiography in children and adults at home and abroad, but there is no uniform standard for echocardiographic parameters in newborns, especially premature infants. At present, there are many problems in establishing the reference range of neonatal echocardiography internationally, including the small sample size included in establishing the reference range, no premature infant standard for some parameters, the reference range is not stratified according to gender, etc. Moreover, the majority of current echocardiographic reference ranges are derived from studies in European and American populations and are not applicable to Asian patients. So far, reference ranges for neonatal echocardiography established based on high-quality clinical studies are still lacking, greatly affecting the use of echocardiography in neonatal intensive care units. Therefore, this study intends to carry out a national multicenter, prospective, observational study to establish the reference range of echocardiography at different time periods after birth in neonates, and stratify according to creatinine, birth weight and gender, providing a reference for the application of echocardiography in neonatal intensive care units, and providing an important basis for the development of TNE-centered neonatal hemodynamic comprehensive assessment program in the NICU.
- Study Design and Process: This study is a multicenter, prospective, observational study. Neonatal bedside echocardiography was performed by a trained neonatology clinician or sonographer. Five time points were selected for neonatal echocardiography, namely, 1 day, 3 days, 7 days, 14 days, and 28 days after birth. The examination was completed in the quiet state of the newborn, and the measurement method was based on the American Guidelines and Standards for Echocardiography in Children and the American NICU Echocardiography Practice Guidelines. All ultrasound data were averaged over three or more cardiac cycles.
- Sample Size Calculation: Each participating NICU will be required to enroll 300 infants (60 infants for each PNA timepoint) for a final sample size of 1500 "normal infants".
- Statistical Methods: Data statistics were performed using SPSS 21.0 software. The data obtained for each of the ultrasound hemodynamic parameters were tested for normality. The measurement data conforming to normal distribution are expressed by mean ± standard deviation, and the measurement data with non-normal distribution are expressed by median (interquartile range). Spearman correlation analysis was used to compare the correlation between different indicators and postnatal, birth weight, birth weight and gender. The echocardiographic reference range of newborns at different time periods after birth was established by 95% confidence interval and stratified according to birth weight, birth weight and gender. P < 0.05 was considered statistically significant.
- Quality control:
At the beginning of the study, a cooperative group kick-off meeting will be organized to interpret the study protocol in detail. In addition, the online or offline training of the participating units will be carried out to further unify the parameter setting and data collection criteria of the ultrasound machine. Establish a WeChat group to answer questions related to this study at any time. During the process of the project, regular contact meetings within the cooperative group will be held to ensure that the investigators participating in the study will implement the protocol. During the study, the study site will assign a special person to review the completeness and correctness of the data submitted by each participating site.
- Conditions
- Echocardiography
- Keywords
- Neonatal Echocardiogram, Reference Ranges, Preterm Infants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
Neonatal bedside echocardiography was performed by a trained neonatologist or sonographer
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in left atrial anteroposterior diameter with increasing age
The Left atrial systolic anteroposterior diameter was measured by M-mode ultrasound through the aortic root in the long axis of the parasternal left ventricle
Measured: 5 time points (1 day, 3 days, 7 days, 14 days and 28 days after birth)
Changes in interventricular septum thickness with increasing age
The Interventricular septal thickness was measured by left ventricular M-mode ultrasound in the long axis of the parasternal left ventricle
Measured: 5 time points (1 day, 3 days, 7 days, 14 days and 28 days after birth)
Changes in left ventricular posterior wall thickness at end diastole with increasing age
The left ventricular posterior wall thickness at end diastole was measured by left ventricular M-mode ultrasound in the long axis of the parasternal left ventricle
Measured: 5 time points (1 day, 3 days, 7 days, 14 days and 28 days after birth)
Changes in left ventricular end diastolic diameter with increasing age
The left ventricular end diastolic diameter was measured by left ventricular M-mode ultrasound in the long axis of the parasternal left ventricle
Measured: 5 time points (1 day, 3 days, 7 days, 14 days and 28 days after birth)
Changes in left ventricular end systolic diameter with increasing age
The left ventricular end systolic diameter was measured by left ventricular M-mode ultrasound in the long axis of the parasternal left ventricle
Measured: 5 time points (1 day, 3 days, 7 days, 14 days and 28 days after birth)
Changes in right ventricular anteroposterior diameter at end diastole with increasing age
The right ventricular anteroposterior diameter at end diastole was measured by left ventricular M-mode ultrasound in the long axis of the parasternal left ventricle
Measured: 5 time points (1 day, 3 days, 7 days, 14 days and 28 days after birth)
Changes in right ventricular outflow tract diameter with increasing age
The right ventricular outflow tract diameter was measured in the short-axis pulmonary valve orifice view of the parasternal great arteries
Measured: 5 time points (1 day, 3 days, 7 days, 14 days and 28 days after birth)
Changes in left ventricular ejection fraction with increasing age
Left ventricular ejection fraction can be calculated by measuring left ventricular end-diastolic diameter and left ventricular end-systolic diameter in a standard parasternal left ventricular long-axis view, at the level of mitral chordae tendineae, or parasternal left ventricular short-axis view, at the level of papillary muscles, with the sampling line perpendicular to the interventricular septum and left ventricular posterior wall
Measured: 5 time points (1 day, 3 days, 7 days, 14 days and 28 days after birth)
Secondary outcomes (4)
Changes in left ventricular outflow tract diameter with increasing age
In the standard parasternal long-axis view, images were frozen when the aortic valve was completely opened during systole, and the distance between the anterior and posterior aortic walls at the level of aortic root attachment was measured with an electronic cursor to obtain the left ventricular outflow tract diameter
Measured: 5 time points (1 day, 3 days, 7 days, 14 days and 28 days after birth)
Changes in main pulmonary artery diameter with increasing age
In the parasternal cardiac base short-axis view, the left and right pulmonary arteries were exposed at the same time, and the diameter of the main pulmonary artery was measured
Measured: 5 time points (1 day, 3 days, 7 days, 14 days and 28 days after birth)
Changes in Inferior vena cava diameter with increasing age
Inferior vena cava diameter was measured by M-mode ultrasound in the subxiphoid long-axis plane by transthoracic ultrasound
Measured: 5 time points (1 day, 3 days, 7 days, 14 days and 28 days after birth)
Changes in Simpson 's method for measuring ejection fraction with increasing age
Through the apical four-chamber view or apical two-chamber view, for the tracing of diastolic and systolic endocardium, divide the heart into several (generally 20) cylinders, calculate the volume and add them to obtain the left ventricular end-diastolic and end-systolic volumes, and then calculate the ejection fraction
Measured: 5 time points (1 day, 3 days, 7 days, 14 days and 28 days after birth)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2022
- Study start15 Nov 2022
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2024 (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 EchocardiographyStudies 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
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Chongqing Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Shanxi Provincial Maternity and Children's Hospital, Inner Mongolia Maternal and Child Health Care Hospital, Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region, Ningxia Medical University
- Responsible party
- Principal investigator, Wang Jianhui, Children's Hospital of Chongqing Medical University
- Investigators
- Wang Jianhui, Doctor, Study director, Children's Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05462301
- Sponsor's protocol ID
- 2022-06-10
- Acronym
- NORRNE
- Status last verified
- Jul 2024
- First submitted
- 25 Jun 2022
- Last updated
- 16 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
El-Khuffash A, Herbozo C, Jain A, Lapointe A, McNamara PJ. Targeted neonatal echocardiography (TnECHO) service in a Canadian neonatal intensive care unit: a 4-year experience. J Perinatol. 2013 Sep;33(9):687-90. doi: 10.1038/jp.2013.42. Epub 2013 Apr 25.
PubMed 23619373Shiraishi H, Yanagisawa M. Pulsed Doppler echocardiographic evaluation of neonatal circulatory changes. Br Heart J. 1987 Feb;57(2):161-7. doi: 10.1136/hrt.57.2.161.
PubMed 3814451Kluckow M, Evans N. Superior vena cava flow in newborn infants: a novel marker of systemic blood flow. Arch Dis Child Fetal Neonatal Ed. 2000 May;82(3):F182-7. doi: 10.1136/fn.82.3.f182.
PubMed 10794783Schmitz L, Stiller B, Pees C, Koch H, Xanthopoulos A, Lange P. Doppler-derived parameters of diastolic left ventricular function in preterm infants with a birth weight <1500 g: reference values and differences to term infants. Early Hum Dev. 2004 Feb;76(2):101-14. doi: 10.1016/j.earlhumdev.2003.11.003.
PubMed 14757262Cosyns B, Lancellotti P. Normal reference values for echocardiography: a call for comparison between ethnicities. Eur Heart J Cardiovasc Imaging. 2016 May;17(5):523-4. doi: 10.1093/ehjci/jev353. Epub 2016 Mar 13. No abstract available.
PubMed 26976356
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Normal Reference Range for Neonatal Echocardiography: a Multi-center, Prospective Study
- ClinicalTrials.gov ID
- NCT05462301
- Acronym / sponsor ID
- NORRNE / 2022-06-10
- Conditions
- Echocardiography
- Keywords
- Neonatal Echocardiogram, Reference Ranges, Preterm Infants
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Children's Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Collaborators
- Shanxi Provincial Maternity and Children's Hospital, Inner Mongolia Maternal and Child Health Care Hospital, Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region, Ningxia Medical University
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 18 Jul 2022 (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.
Echocardiography is the main method of bedside examination of neonatal cardiac morphology, which can timely diagnose congenital heart disease and quantitatively assess its severity, but the diagnosis and evaluation process depends on the normal range of neonatal echocardiography.At present, there have been normal reference standards for echocardiography in children and adults at home and abroad, but there is no uniform standard for echocardiographic parameters in newborns, especially premature infants.This study intends to carry out a national multicenter, prospective, observational study to establish the reference range of echocardiography at different time periods after birth in newborns, and stratified according to gestational age, birth weight and gender, to conduct a more accurate hemodynamic assessment of clinically critically ill newborns and guide the treatment of critically ill newborns in real time.
Detailed description
Neonatal goal-directed echocardiography (TNE) performed by neonatologists has been increasingly applied to hemodynamic assessment in the NICU to guide critical neonatal treatment in real time. There are many detection indexes of TNE, which are closely related to neonatal weight, birth weight, postnatal age, race and other factors. Therefore, establishing neonatal echocardiographic reference ranges is essential for the development of TNE. At present, there have been normal reference standards for echocardiography in children and adults at home and abroad, but there is no uniform standard for echocardiographic parameters in newborns, especially premature infants. At present, there are many problems in establishing the reference range of neonatal echocardiography internationally, including the small sample size included in establishing the reference range, no premature infant standard for some parameters, the reference range is not stratified according to gender, etc. Moreover, the majority of current echocardiographic reference ranges are derived from studies in European and American populations and are not applicable to Asian patients. So far, reference ranges for neonatal echocardiography established based on high-quality clinical studies are still lacking, greatly affecting the use of echocardiography in neonatal intensive care units. Therefore, this study intends to carry out a national multicenter, prospective, observational study to establish the reference range of echocardiography at different time periods after birth in neonates, and stratify according to creatinine, birth weight and gender, providing a reference for the application of echocardiography in neonatal intensive care units, and providing an important basis for the development of TNE-centered neonatal hemodynamic comprehensive assessment program in the NICU.
- Study Design and Process: This study is a multicenter, prospective, observational study. Neonatal bedside echocardiography was performed by a trained neonatology clinician or sonographer. Five time points were selected for neonatal echocardiography, namely, 1 day, 3 days, 7 days, 14 days, and 28 days after birth. The examination was completed in the quiet state of the newborn, and the measurement method was based on the American Guidelines and Standards for Echocardiography in Children and the American NICU Echocardiography Practice Guidelines. All ultrasound data were averaged over three or more cardiac cycles.
- Sample Size Calculation: Each participating NICU will be required to enroll 300 infants (60 infants for each PNA timepoint) for a final sample size of 1500 "normal infants".
- Statistical Methods: Data statistics were performed using SPSS 21.0 software. The data obtained for each of the ultrasound hemodynamic parameters were tested for normality. The measurement data conforming to normal distribution are expressed by mean ± standard deviation, and the measurement data with non-normal distribution are expressed by median (interquartile range). Spearman correlation analysis was used to compare the correlation between different indicators and postnatal, birth weight, birth weight and gender. The echocardiographic reference range of newborns at different time periods after birth was established by 95% confidence interval and stratified according to birth weight, birth weight and gender. P < 0.05 was considered statistically significant.
- Quality control:
At the beginning of the study, a cooperative group kick-off meeting will be organized to interpret the study protocol in detail. In addition, the online or offline training of the participating units will be carried out to further unify the parameter setting and data collection criteria of the ultrasound machine. Establish a WeChat group to answer questions related to this study at any time. During the process of the project, regular contact meetings within the cooperative group will be held to ensure that the investigators participating in the study will implement the protocol. During the study, the study site will assign a special person to review the completeness and correctness of the data submitted by each participating site.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- healthy neonates and preterm Infants
Key inclusion criteria (6 listed)
- Outpatient or inpatient neonate
- Gestational age > 30weeks and birthweight > 1250 grams
- Appropriate for gestational age
- Without perinatal asphyxia
- Without skin lesion on the left chest wall
Key exclusion criteria (11 listed)
- specialist cardiac ultrasound suggests congenital heart disease;
- PDA with hemodynamic abnormalities, defined as: PDA > 1.5 mm (left-to-right shunt) and left atrial diameter/aortic root > 1.5 or the need for the use of inotropes;
- invasive mechanical ventilation therapy,
- non-invasive mechanical ventilation with FiO2 >0.3
- major anomalies
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 |
|---|---|---|
| Neonatal bedside echocardiography was performed by a trained neonatologist or sonographer | Other | – |
Primary outcome
Changes in left atrial anteroposterior diameter with increasing age
Time frame: 5 time points (1 day, 3 days, 7 days, 14 days and 28 days after birth)
The Left atrial systolic anteroposterior diameter was measured by M-mode ultrasound through the aortic root in the long axis of the parasternal left ventricle
Changes in interventricular septum thickness with increasing age
Time frame: 5 time points (1 day, 3 days, 7 days, 14 days and 28 days after birth)
The Interventricular septal thickness was measured by left ventricular M-mode ultrasound in the long axis of the parasternal left ventricle
Changes in left ventricular posterior wall thickness at end diastole with increasing age
Time frame: 5 time points (1 day, 3 days, 7 days, 14 days and 28 days after birth)
The left ventricular posterior wall thickness at end diastole was measured by left ventricular M-mode ultrasound in the long axis of the parasternal left ventricle
Changes in left ventricular end diastolic diameter with increasing age
Time frame: 5 time points (1 day, 3 days, 7 days, 14 days and 28 days after birth)
The left ventricular end diastolic diameter was measured by left ventricular M-mode ultrasound in the long axis of the parasternal left ventricle
Changes in left ventricular end systolic diameter with increasing age
Time frame: 5 time points (1 day, 3 days, 7 days, 14 days and 28 days after birth)
The left ventricular end systolic diameter was measured by left ventricular M-mode ultrasound in the long axis of the parasternal left ventricle
Changes in right ventricular anteroposterior diameter at end diastole with increasing age
Time frame: 5 time points (1 day, 3 days, 7 days, 14 days and 28 days after birth)
The right ventricular anteroposterior diameter at end diastole was measured by left ventricular M-mode ultrasound in the long axis of the parasternal left ventricle
Changes in right ventricular outflow tract diameter with increasing age
Time frame: 5 time points (1 day, 3 days, 7 days, 14 days and 28 days after birth)
The right ventricular outflow tract diameter was measured in the short-axis pulmonary valve orifice view of the parasternal great arteries
Changes in left ventricular ejection fraction with increasing age
Time frame: 5 time points (1 day, 3 days, 7 days, 14 days and 28 days after birth)
Left ventricular ejection fraction can be calculated by measuring left ventricular end-diastolic diameter and left ventricular end-systolic diameter in a standard parasternal left ventricular long-axis view, at the level of mitral chordae tendineae, or parasternal left ventricular short-axis view, at the level of papillary muscles, with the sampling line perpendicular to the interventricular septum and left ventricular posterior wall
4 secondary outcomes
Changes in left ventricular outflow tract diameter with increasing age
Time frame: 5 time points (1 day, 3 days, 7 days, 14 days and 28 days after birth)
Changes in main pulmonary artery diameter with increasing age
Time frame: 5 time points (1 day, 3 days, 7 days, 14 days and 28 days after birth)
Changes in Inferior vena cava diameter with increasing age
Time frame: 5 time points (1 day, 3 days, 7 days, 14 days and 28 days after birth)
Changes in Simpson 's method for measuring ejection fraction with increasing age
Time frame: 5 time points (1 day, 3 days, 7 days, 14 days and 28 days after birth)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
- Results publication: PubMed 23619373El-Khuffash A, Herbozo C, Jain A, Lapointe A, McNamara PJ. Targeted neonatal echocardiography (TnECHO) service in a Canadian neonatal intensive care unit: a 4-year experience. J Perinatol. 2013 Sep;33(9):687-90. doi: 10.1038/jp.2013.42. Epub 2013 Apr 25.
- Results publication: PubMed 3814451Shiraishi H, Yanagisawa M. Pulsed Doppler echocardiographic evaluation of neonatal circulatory changes. Br Heart J. 1987 Feb;57(2):161-7. doi: 10.1136/hrt.57.2.161.
- Results publication: PubMed 10794783Kluckow M, Evans N. Superior vena cava flow in newborn infants: a novel marker of systemic blood flow. Arch Dis Child Fetal Neonatal Ed. 2000 May;82(3):F182-7. doi: 10.1136/fn.82.3.f182.
- Results publication: PubMed 14757262Schmitz L, Stiller B, Pees C, Koch H, Xanthopoulos A, Lange P. Doppler-derived parameters of diastolic left ventricular function in preterm infants with a birth weight <1500 g: reference values and differences to term infants. Early Hum Dev. 2004 Feb;76(2):101-14. doi: 10.1016/j.earlhumdev.2003.11.003.
- Results publication: PubMed 26976356Cosyns B, Lancellotti P. Normal reference values for echocardiography: a call for comparison between ethnicities. Eur Heart J Cardiovasc Imaging. 2016 May;17(5):523-4. doi: 10.1093/ehjci/jev353. Epub 2016 Mar 13. No abstract available.
- 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.
Wang Jianhui, Doctor study director
Children's Hospital of Chongqing Medical University
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, run by Children's Hospital of Chongqing Medical University 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 6 inclusion and 11 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 16 Jul 2024. 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 Wang Jianhui, Doctor (+8613678428167, tonywenhui@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in left atrial anteroposterior diameter with increasing age (time frame: 5 time points (1 day, 3 days, 7 days, 14 days and 28 days after birth)). The study lists 8 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 NCT05462301, 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 16 Jul 2024.