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Recruiting NCT05462301

Normal Reference Range for Neonatal Echocardiography

Trial Parameters

Condition Echocardiography
Sponsor Children's Hospital of Chongqing Medical University
Study Type OBSERVATIONAL
Phase N/A
Enrollment 1,500
Sex ALL
Min Age 1 Day
Max Age 28 Days
Start Date 2022-11-15
Completion 2024-12-30

Brief 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 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

Inclusion Criteria: * 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 Exclusion Criteria: * 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 * persistent pulmonary hypertension * renal failure * necrotizing enterocolitis ≥ stage II * post surgery * Maternal history of severe anemia, or prenatal massive bleeding

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