Echocardiographic Screening of Healthy Neonates for Measuring Pulmonary Artery Pressure

Pulmonary Hypertension of Newborn Clinical Trial

Official title:

Echocardiographic Screening of Healthy Neonates for Measuring Pulmonary Artery Pressure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05050045
• Other study ID #: 0106488
• Status: Completed
• Start date: August 1, 2020
• Est. completion date: August 15, 2021

Study information

• Verified date: November 2021
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: August 15, 2021
• Est. primary completion date: August 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Hours

Eligibility

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

Related Conditions & MeSH terms

• Hypertension, Pulmonary
• Pulmonary Hypertension of Newborn

Locations

Country	Name	City	State
Egypt	Neonatal Intensive Care Unit (NICU) of Alexandria University Maternity Hospital.	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Marwa Mohamed Farag

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulmonary artery pressure (PAP) assessment - Tricuspid valve regurgitation peak velocity	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)	up to 72 hours
Primary	Pulmonary artery pressure (PAP) assessment - Pulmonary regurgitation peak velocity	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)	up to 72 hours
Primary	Pulmonary artery pressure (PAP) assessment - Transductal right-to-left flow peak velocity	This is measured in high short axis ductal view with continuous wave Doppler	up to 72 hours
Primary	Pulmonary artery pressure (PAP) assessment - Interventricular septum configuration	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.	up to 72 hours
Primary	Pulmonary artery pressure (PAP) assessment - Left ventricle systolic eccentricity index (LV-sEI)	This is measured in short axis parasternal view by measuring LV dimensions the parallel versus the perpendicular dimension. The normal ratio is 1.	up to 72 hours
Primary	Right ventricular performance - Tricuspid annular plane systolic excursion(TAPSE)	This is measured using Mmode in apical 4 chamber view over lateral annulus of tricuspid valve	up to 72 hours
Primary	Right ventricular performance - Myocardial Performance Index (MPI)	This is measured by using pulsed wave doppler to measure isovolumetric ejection time + isovolumetric relaxation time/ right ventricular ejection time.	up to 72 hours
Primary	Right ventricular performance - E/A ratio	This is measured in apical 4 chamber view by pulsed wave Doppler on mitral valve. The cut off value: 0.8- 2.	up to 72 hours
Primary	Left ventricular performance - Ejection fraction	This is measured using M-Mode in long axis parasternal view with a normal range of 55-75%	up to 72 hours
Primary	Left ventricular performance - E/A ratio	This is measured in apical 4 chamber view by pulsed wave Doppler on mitral valve. The cut off value: 0.8- 2	up to 72 hours
Primary	Shunts evaluation - Patent Ductus arteriosus	Size will be evaluated in short axis parasternal view	up to 72 hours
Primary	Shunts evaluation - Patent Ductus arteriosus	Direction will be evaluated in short axis parasternal view using color Doppler	up to 72 hours
Primary	Shunts evaluation - Patent Foramen Ovale	Size will be evaluated in be viewed in subcostal view	up to 72 hours
Primary	Shunts evaluation - Patent Foramen Ovale	Direction will be evaluated in subcostal view using color Doppler	up to 72 hours