Echocardiographic Screening of Healthy Neonates for Measuring Pulmonary Artery Pressure

NCT05050045 | Completed

• 1 other identifier: 0106488
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Hypertension of Newborn

Outcome Measures

Primary Outcomes (14)

• 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

Eligibility Criteria

• Age: 0 Minutes - 6 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marwa Mohamed Farag: lead

Study Sites (1)

Neonatal Intensive Care Unit (NICU) of Alexandria University Maternity Hospital.

Alexandria, 21131, Egypt

Location

Study Officials

• Rana EO Kandil, MBBCh

  Faculty of Medicine, Alexandria University, Egypt

  PRINCIPAL INVESTIGATOR

• Aly M Abdel-Mohsen, PhD

  Faculty of Medicine, Alexandria University, Egypt

  STUDY DIRECTOR

• Marwa M Farag, PhD

  Faculty of Medicine, Alexandria University, Egypt

  STUDY CHAIR

• Mohamed A Khalifa, MBBCh

  Faculty of Medicine, Alexandria University, Egypt

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer in Pediatrics, Faculty of Medicine

Study Record Dates

• First Submitted: September 10, 2021
• First Posted: September 20, 2021
• Study Start: August 1, 2020
• Primary Completion: August 10, 2021
• Study Completion: August 15, 2021
• Last Updated: November 4, 2021

Record last verified: 2021-11

Locations

EG (1)