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Clinical Trials/NCT05050045
NCT05050045
Completed
Not Applicable

Echocardiographic Screening of Healthy Neonates for Measuring Pulmonary Artery Pressure

Marwa Mohamed Farag1 site in 1 country110 target enrollmentAugust 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pulmonary Hypertension of Newborn
Sponsor
Marwa Mohamed Farag
Enrollment
110
Locations
1
Primary Endpoint
Pulmonary artery pressure (PAP) assessment - Tricuspid valve regurgitation peak velocity
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

The aim of the present prospective study was to evaluate dynamic changes in both pulmonary artery pressure and ductus arteriosus during the first 72 hours after birth.

Detailed Description

Healthy newborn infants born in Alexandria University Children's Hospital were studied. Dynamic changes during the first 72 hours after birth were evaluated.

Registry
clinicaltrials.gov
Start Date
August 1, 2020
End Date
August 15, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Marwa Mohamed Farag
Responsible Party
Sponsor Investigator
Principal Investigator

Marwa Mohamed Farag

Lecturer in Pediatrics, Faculty of Medicine

Alexandria University

Eligibility Criteria

Inclusion Criteria

  • Gestational age: 37-42 weeks.
  • Birthweight: 2500-4000 g.

Exclusion Criteria

  • Neonates more than 6 hours of age at time of enrollment.
  • Perinatal asphyxia or hypoxia (1 min Apgar scoring\<7 points)
  • Cardiac structural abnormalities detected by echocardiography except patent foramen ovale and patent ductus arteriosus
  • Other clinically detected congenital malformations such as cleft lip and palate, omphalocele, meningocele, etc.
  • Maternal history of gestational hypertension, gestational diabetes, hyperthyroidism, hypothyroidism, and autoimmune disease

Outcomes

Primary Outcomes

Pulmonary artery pressure (PAP) assessment - Tricuspid valve regurgitation peak velocity

Time Frame: up to 72 hours

This is measured in apical 4 chamber view, with continuous wave Doppler using modified Bernoulli equation. Systolic pulmonary artery pressure is equivalent to right ventricular systolic pressure in absence of outflow obstruction. Systolic Pulmonary Artery Pressure (SPAP) = Right Ventricular Systolic Pressure = 4x TR2 + Right Atrial Pressure (RAP) (RAP= 3-5 mmHg)

Pulmonary artery pressure (PAP) assessment - Pulmonary regurgitation peak velocity

Time Frame: up to 72 hours

This is measured in short axis parasternal view with continuous wave Doppler using this equation: Mean Pulmonary Artery Pressure MPAP= 4xPR2 + Right Ventricular Diastolic Pressure (RVdP=2-5 mmHg)

Pulmonary artery pressure (PAP) assessment - Transductal right-to-left flow peak velocity

Time Frame: up to 72 hours

This is measured in high short axis ductal view with continuous wave Doppler

Pulmonary artery pressure (PAP) assessment - Interventricular septum configuration

Time Frame: up to 72 hours

This is measured in short axis parasternal view above level of papillary muscles, left ventricle is normally O shaped, D or crescent shape indicated bowing of septum due to RV dysfunction.

Pulmonary artery pressure (PAP) assessment - Left ventricle systolic eccentricity index (LV-sEI)

Time Frame: up to 72 hours

This is measured in short axis parasternal view by measuring LV dimensions the parallel versus the perpendicular dimension. The normal ratio is 1.

Right ventricular performance - Tricuspid annular plane systolic excursion(TAPSE)

Time Frame: up to 72 hours

This is measured using Mmode in apical 4 chamber view over lateral annulus of tricuspid valve

Right ventricular performance - Myocardial Performance Index (MPI)

Time Frame: up to 72 hours

This is measured by using pulsed wave doppler to measure isovolumetric ejection time + isovolumetric relaxation time/ right ventricular ejection time.

Right ventricular performance - E/A ratio

Time Frame: up to 72 hours

This is measured in apical 4 chamber view by pulsed wave Doppler on mitral valve. The cut off value: 0.8- 2.

Left ventricular performance - Ejection fraction

Time Frame: up to 72 hours

This is measured using M-Mode in long axis parasternal view with a normal range of 55-75%

Left ventricular performance - E/A ratio

Time Frame: up to 72 hours

This is measured in apical 4 chamber view by pulsed wave Doppler on mitral valve. The cut off value: 0.8- 2

Shunts evaluation - Patent Ductus arteriosus

Time Frame: up to 72 hours

Direction will be evaluated in short axis parasternal view using color Doppler

Shunts evaluation - Patent Foramen Ovale

Time Frame: up to 72 hours

Direction will be evaluated in subcostal view using color Doppler

Study Sites (1)

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