Normal Reference Range for Neonatal Echocardiography

NCT05462301 | Recruiting DMC

• 1 other identifier: 2022-06-10
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Echocardiography

Keywords

Neonatal Echocardiogram; Reference Ranges; Preterm Infants

Outcome Measures

Primary Outcomes (8)

• 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

  5 time points (1 day, 3 days, 7 days, 14 days and 28 days after birth)

• 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

  5 time points (1 day, 3 days, 7 days, 14 days and 28 days after birth)

• 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

  5 time points (1 day, 3 days, 7 days, 14 days and 28 days after birth)

• 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

  5 time points (1 day, 3 days, 7 days, 14 days and 28 days after birth)

• Changes in left ventricular end systolic diameter with increasing age

  The left ventricular end systolic diameter was measured by left ventricular M-mode ultrasound in the long axis of the parasternal left ventricle

  5 time points (1 day, 3 days, 7 days, 14 days and 28 days after birth)

• Changes in right ventricular anteroposterior diameter at end diastole with increasing age

  The right ventricular anteroposterior diameter at end diastole was measured by left ventricular M-mode ultrasound in the long axis of the parasternal left ventricle

  5 time points (1 day, 3 days, 7 days, 14 days and 28 days after birth)

• Changes in right ventricular outflow tract diameter with increasing age

  The right ventricular outflow tract diameter was measured in the short-axis pulmonary valve orifice view of the parasternal great arteries

  5 time points (1 day, 3 days, 7 days, 14 days and 28 days after birth)

• Changes in left ventricular ejection fraction with increasing age

  Left ventricular ejection fraction can be calculated by measuring left ventricular end-diastolic diameter and left ventricular end-systolic diameter in a standard parasternal left ventricular long-axis view, at the level of mitral chordae tendineae, or parasternal left ventricular short-axis view, at the level of papillary muscles, with the sampling line perpendicular to the interventricular septum and left ventricular posterior wall

  5 time points (1 day, 3 days, 7 days, 14 days and 28 days after birth)

Secondary Outcomes (4)

• Changes in left ventricular outflow tract diameter with increasing age

  5 time points (1 day, 3 days, 7 days, 14 days and 28 days after birth)

• Changes in main pulmonary artery diameter with increasing age

  5 time points (1 day, 3 days, 7 days, 14 days and 28 days after birth)

• Changes in Inferior vena cava diameter with increasing age

  5 time points (1 day, 3 days, 7 days, 14 days and 28 days after birth)

• Changes in Simpson 's method for measuring ejection fraction with increasing age

  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

  5 time points (1 day, 3 days, 7 days, 14 days and 28 days after birth)

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

healthy neonates and preterm Infants

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital of Chongqing Medical University: lead
• 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

Study Sites (1)

Children's Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400014, China

RECRUITING

Related Publications (5)

• El-Khuffash A, Herbozo C, Jain A, Lapointe A, McNamara PJ. Targeted neonatal echocardiography (TnECHO) service in a Canadian neonatal intensive care unit: a 4-year experience. J Perinatol. 2013 Sep;33(9):687-90. doi: 10.1038/jp.2013.42. Epub 2013 Apr 25.

  PMID: 23619373 RESULT

• Shiraishi H, Yanagisawa M. Pulsed Doppler echocardiographic evaluation of neonatal circulatory changes. Br Heart J. 1987 Feb;57(2):161-7. doi: 10.1136/hrt.57.2.161.

  PMID: 3814451 RESULT

• Kluckow M, Evans N. Superior vena cava flow in newborn infants: a novel marker of systemic blood flow. Arch Dis Child Fetal Neonatal Ed. 2000 May;82(3):F182-7. doi: 10.1136/fn.82.3.f182.

  PMID: 10794783 RESULT

• Schmitz L, Stiller B, Pees C, Koch H, Xanthopoulos A, Lange P. Doppler-derived parameters of diastolic left ventricular function in preterm infants with a birth weight <1500 g: reference values and differences to term infants. Early Hum Dev. 2004 Feb;76(2):101-14. doi: 10.1016/j.earlhumdev.2003.11.003.

  PMID: 14757262 RESULT

• Cosyns B, Lancellotti P. Normal reference values for echocardiography: a call for comparison between ethnicities. Eur Heart J Cardiovasc Imaging. 2016 May;17(5):523-4. doi: 10.1093/ehjci/jev353. Epub 2016 Mar 13. No abstract available.

  PMID: 26976356 RESULT

Study Officials

• Wang Jianhui, Doctor

  Children's Hospital of Chongqing Medical University

  STUDY DIRECTOR

Central Study Contacts

Wang Jianhui, Doctor

CONTACT

+8613678428167; tonywenhui@hotmail.com

Dong Wenhui, Master

CONTACT

+8615826122681; 376561086@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Project Leader

Study Record Dates

• First Submitted: June 25, 2022
• First Posted: July 18, 2022
• Study Start: November 15, 2022
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: July 16, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)