Normal Reference Range for Neonatal Echocardiography
ConditionEchocardiography
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-28
SponsorChildren's Hospital of Chongqing Medical University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Outpatient or inpatient neonate
Gestational age > 30weeks and birthweight > 1250 grams
Appropriate for gestational age
Without perinatal asphyxia
Disqualifiers
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
Trial population
healthy neonates and preterm Infants
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
- Other intervention
Neonatal bedside echocardiography was performed by a trained neonatologist or sonographer
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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
Time frame
5 time points (1 day, 3 days, 7 days, 14 days and 28 days after birth)2
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
Time frame
5 time points (1 day, 3 days, 7 days, 14 days and 28 days after birth)3
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
Time frame
5 time points (1 day, 3 days, 7 days, 14 days and 28 days after birth)4
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
Time frame
5 time points (1 day, 3 days, 7 days, 14 days and 28 days after birth)Secondary outcomes
1
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
Time frame
5 time points (1 day, 3 days, 7 days, 14 days and 28 days after birth)2
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
Time frame
5 time points (1 day, 3 days, 7 days, 14 days and 28 days after birth)3
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
Time frame
5 time points (1 day, 3 days, 7 days, 14 days and 28 days after birth)4
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
Time frame
5 time points (1 day, 3 days, 7 days, 14 days and 28 days after birth)Other outcomes
1
Changes in Aortic Velocity Time Integral（VTI）with increasing age
In the apical five-chamber view, select the color Doppler mode to display the aortic blood flow signal and direction, place the sampling volume below the arterial orifice, adjust the blood flow direction as parallel as possible to the sampling line through the left and right swing probe, and select the pulsed Doppler mode (PW), then the velocity time integral (VTI) image of aortic blood flow can be obtained. Trace the aortic velocity-time integral image and calculate the VTI value in cm by computer or plotter. Select 3-5 consecutive VTI images within the same respiratory cycle for measurement and average to reduce the impact of the respiratory cycle
Time frame
5 time points (1 day, 3 days, 7 days, 14 days and 28 days after birth)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Children's Hospital of Chongqing Medical University
Lead sponsor
Shanxi Provincial Maternity and Children's Hospital
Collaborator
Inner Mongolia Maternal and Child Health Care Hospital
Collaborator
Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region
Collaborator
Ningxia Medical University
Collaborator
Source ClinicalTrials.gov