Echocardiographic Screening of Healthy Neonates for Measuring Pulmonary Artery Pressure

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Hypertension of Newborn

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 Type: Observational
• Enrollment (Actual): 110

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt, 21131
    • Neonatal Intensive Care Unit (NICU) of Alexandria University Maternity Hospital.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 6 hours (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Healthy newborn infants born in Alexandria University Children's Hospital were studied. Dynamic changes in both pulmonary artery pressure and ductus arteriosus during the first 72 hours after birth were evaluated.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
Shunts evaluation - Patent Ductus arteriosus	Size will be evaluated in short axis parasternal view	up to 72 hours
Shunts evaluation - Patent Ductus arteriosus	Direction will be evaluated in short axis parasternal view using color Doppler	up to 72 hours
Shunts evaluation - Patent Foramen Ovale	Size will be evaluated in be viewed in subcostal view	up to 72 hours
Shunts evaluation - Patent Foramen Ovale	Direction will be evaluated in subcostal view using color Doppler	up to 72 hours

Collaborators and Investigators

• Sponsor: Marwa Mohamed Farag
• Investigators: Study Director: Aly M Abdel-Mohsen, PhD, Faculty of Medicine, Alexandria University, Egypt; Principal Investigator: Rana EO Kandil, MBBCh, Faculty of Medicine, Alexandria University, Egypt; Study Director: Mohamed A Khalifa, MBBCh, Faculty of Medicine, Alexandria University, Egypt

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Actual): August 10, 2021
• Study Completion (Actual): August 15, 2021

Study Registration Dates

• First Submitted: September 10, 2021
• First Submitted That Met QC Criteria: September 10, 2021
• First Posted (Actual): September 20, 2021

Study Record Updates

• Last Update Posted (Actual): November 4, 2021
• Last Update Submitted That Met QC Criteria: November 2, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Hypertension, Pulmonary
• Other Study ID Numbers: 0106488

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No