NCT05462301 Normal Reference Range for Neonatal Echocardiography
| NCT ID | NCT05462301 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Children's Hospital of Chongqing Medical University |
| Condition | Echocardiography |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,500 participants |
| Start Date | 2022-11-15 |
| Primary Completion | 2024-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,500 participants in total. It began in 2022-11-15 with a primary completion date of 2024-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Wang Jianhui, Doctor
STUDY DIRECTOR
Children's Hospital of Chongqing Medical University
Frequently Asked Questions
Who can join the NCT05462301 clinical trial?
This trial is open to participants of all sexes, aged 1 Day or older, up to 28 Days, studying Echocardiography. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05462301 currently recruiting?
Yes, NCT05462301 is actively recruiting participants. Contact the research team at tonywenhui@hotmail.com for enrollment information.
Where is the NCT05462301 trial being conducted?
This trial is being conducted at Chongqing, China.
Who is sponsoring the NCT05462301 clinical trial?
NCT05462301 is sponsored by Children's Hospital of Chongqing Medical University. The principal investigator is Wang Jianhui, Doctor at Children's Hospital of Chongqing Medical University. The trial plans to enroll 1,500 participants.