Echocardiographic Screening of Healthy Neonates for Measuring Pulmonary Artery Pressure

Completed

• Conditions: Pulmonary Hypertension of Newborn

• Registration Number: NCT05050045
• Lead Sponsor: Marwa Mohamed Farag

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.

Study Timeline

• Study Start: 2020-08-01
• Primary Completion: 2021-08-10
• Study Completion: 2021-08-15
• Study First Submitted: 2021-09-10
• Study First Submitted QC: 2021-09-10
• Study First Posted: 2021-09-20
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-02
• Last Update Posted: 2021-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pulmonary artery pressure (PAP) assessment - Tricuspid valve regurgitation peak velocity	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	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	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	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)	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)	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)	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	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	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	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	up to 72 hours	Direction will be evaluated in short axis parasternal view using color Doppler
Shunts evaluation - Patent Foramen Ovale	up to 72 hours	Direction will be evaluated in subcostal view using color Doppler

Trial Locations

Locations (1)

Neonatal Intensive Care Unit (NICU) of Alexandria University Maternity Hospital.; 🇪🇬 Alexandria, Egypt