Establishing normal echocardiography reference ranges for newborns
Normal Reference Range for Neonatal Echocardiography: a Multi-center, Prospective Study
This study is trying to set normal heart measurement ranges for newborns, especially preterm babies, to help doctors better diagnose and treat heart problems.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1500 (estimated) |
| Ages | 1 Day to 28 Days |
| Sex | All |
| Sponsor | Children's Hospital of Chongqing Medical University Academic / other |
| Locations | 1 site (Chongqing, Chongqing Municipality) |
| Trial ID | NCT05462301 on ClinicalTrials.gov |
What this trial studies
This observational study aims to establish normal reference ranges for neonatal echocardiography, particularly focusing on preterm infants. It will be a national multicenter, prospective study that collects echocardiographic data from newborns stratified by gestational age, birth weight, and gender. The goal is to provide accurate hemodynamic assessments for critically ill newborns in real-time, addressing the lack of standardized reference ranges currently available. By doing so, the study seeks to improve the diagnosis and treatment of congenital heart disease in neonates.
Who should consider this trial
Good fit: Ideal candidates for this study are neonates with a gestational age greater than 30 weeks and a birth weight over 1250 grams, who are appropriate for their gestational age.
Not a fit: Patients with congenital heart disease or significant comorbidities such as major anomalies or severe respiratory distress may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate diagnoses and better treatment outcomes for critically ill newborns with cardiac issues.
How similar studies have performed: While there have been studies establishing echocardiographic reference ranges for older populations, this approach for newborns, especially in Asian populations, is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chongqing, Chongqing Municipality
- Children's Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Wang Jianhui, Doctor
- Email: tonywenhui@hotmail.com
- Phone: +8613678428167
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.