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Echocardiographic Screening of Healthy Neonates for Measuring Pulmonary Artery Pressure

Echocardiographic Screening of Healthy Neonates for Measuring Pulmonary Artery Pressure

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05050045
Enrollment
110
Registered
2021-09-20
Start date
2020-08-01
Completion date
2021-08-15
Last updated
2021-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Hypertension of Newborn

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.

Interventions

None listed

Sponsors

Marwa Mohamed Farag
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
0 Minutes to 6 Hours
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Shunts evaluation - Patent Ductus arteriosusup to 72 hoursSize will be evaluated in short axis parasternal view
Shunts evaluation - Patent Foramen Ovaleup to 72 hoursSize will be evaluated in be viewed in subcostal view
Pulmonary artery pressure (PAP) assessment - Tricuspid valve regurgitation peak velocityup to 72 hoursThis 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 velocityup to 72 hoursThis 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 velocityup to 72 hoursThis is measured in high short axis ductal view with continuous wave Doppler
Pulmonary artery pressure (PAP) assessment - Interventricular septum configurationup to 72 hoursThis 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 hoursThis 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 hoursThis 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 hoursThis is measured by using pulsed wave doppler to measure isovolumetric ejection time + isovolumetric relaxation time/ right ventricular ejection time.
Right ventricular performance - E/A ratioup to 72 hoursThis 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 fractionup to 72 hoursThis is measured using M-Mode in long axis parasternal view with a normal range of 55-75%
Left ventricular performance - E/A ratioup to 72 hoursThis is measured in apical 4 chamber view by pulsed wave Doppler on mitral valve. The cut off value: 0.8- 2

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026