Actively Recruiting

Age: 1Day - 28Days
All Genders
Healthy Volunteers
NCT05462301

Normal Reference Range for Neonatal Echocardiography

Led by Children's Hospital of Chongqing Medical University · Updated on 2024-07-16

1500

Participants Needed

1

Research Sites

110 weeks

Total Duration

On this page

Sponsors

C

Children's Hospital of Chongqing Medical University

Lead Sponsor

S

Shanxi Provincial Maternity and Children's Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Normal Reference Range for Neonatal Echocardiography

Who Can Participate

Age: 1Day - 28Days
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Outpatient or inpatient neonate
  • Gestational age > 30 weeks and birthweight > 1250 grams
  • Appropriate for gestational age
  • Without perinatal asphyxia
  • Without skin lesion on the left chest wall
  • Family informed consent for neonatal echocardiography
Not Eligible

You will not qualify if you...

  • Specialist cardiac ultrasound suggests congenital heart disease
  • PDA with hemodynamic abnormalities (PDA > 1.5 mm left-to-right shunt and left atrial diameter/aortic root > 1.5 or need for 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

AI-Screening

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Trial Site Locations

Total: 1 location

1

Children's Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China, 400014

Actively Recruiting

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Research Team

W

Wang Jianhui, Doctor

CONTACT

D

Dong Wenhui, Master

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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