Pulmonary Hypertension of NewbornNCT05050045
Echocardiographic Screening of Healthy Neonates for Measuring Pulmonary Artery Pressure
An observational study of Pulmonary Hypertension of Newborn, run by Marwa Mohamed Farag at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 0 minutes to 6 hours
- Conditions the study is for
- Pulmonary Hypertension of Newborn
- How many people
- 110 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2020to 15 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 minutes to 6 hours
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- Gestational age: 37-42 weeks.
- Birthweight: 2500-4000 g.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Neonatal Intensive Care Unit (NICU) of Alexandria University Maternity Hospital.
Alexandria, 21131
About this study
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.
Read the 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.
- Conditions
- Pulmonary Hypertension of Newborn
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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%
Measured: 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
Measured: up to 72 hours
Shunts evaluation - Patent Ductus arteriosus
Size will be evaluated in short axis parasternal view
Measured: up to 72 hours
Shunts evaluation - Patent Ductus arteriosus
Direction will be evaluated in short axis parasternal view using color Doppler
Measured: up to 72 hours
Shunts evaluation - Patent Foramen Ovale
Size will be evaluated in be viewed in subcostal view
Measured: up to 72 hours
Shunts evaluation - Patent Foramen Ovale
Direction will be evaluated in subcostal view using color Doppler
Measured: up to 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2021
- Study start1 Aug 2020
- Primary completion10 Aug 2021
- Study completion15 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Hypertension of NewbornStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marwa Mohamed Farag
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marwa Mohamed Farag, Alexandria University
- Investigators
- Rana EO Kandil, MBBCh, Principal investigator, Faculty of Medicine, Alexandria University, EgyptAly M Abdel-Mohsen, PhD, Study director, Faculty of Medicine, Alexandria University, EgyptMarwa M Farag, PhD, Study chair, Faculty of Medicine, Alexandria University, EgyptMohamed A Khalifa, MBBCh, Study director, Faculty of Medicine, Alexandria University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05050045
- Sponsor's protocol ID
- 0106488
- Status last verified
- Nov 2021
- First submitted
- 10 Sep 2021
- Last updated
- 4 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Echocardiographic Screening of Healthy Neonates for Measuring Pulmonary Artery Pressure
- ClinicalTrials.gov ID
- NCT05050045
- Acronym / sponsor ID
- 0106488
- Conditions
- Pulmonary Hypertension of Newborn
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Marwa Mohamed FaragUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 10 Aug 2021 (actual)
- Study completion
- 15 Aug 2021 (actual)
- First posted
- 20 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 0 minutes to 6 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (2 listed)
- Gestational age: 37-42 weeks.
- Birthweight: 2500-4000 g.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pulmonary artery pressure (PAP) assessment - Tricuspid valve regurgitation peak velocity
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: up to 72 hours
Size will be evaluated in short axis parasternal view
Shunts evaluation - Patent Ductus arteriosus
Time frame: up to 72 hours
Direction will be evaluated in short axis parasternal view using color Doppler
Shunts evaluation - Patent Foramen Ovale
Time frame: up to 72 hours
Size will be evaluated in be viewed in subcostal view
Shunts evaluation - Patent Foramen Ovale
Time frame: up to 72 hours
Direction will be evaluated in subcostal view using color Doppler
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rana EO Kandil, MBBCh principal investigator
Faculty of Medicine, Alexandria University, Egypt
Aly M Abdel-Mohsen, PhD study director
Faculty of Medicine, Alexandria University, Egypt
Marwa M Farag, PhD study chair
Faculty of Medicine, Alexandria University, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Hypertension of Newborn, run by Marwa Mohamed Farag at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary artery pressure (PAP) assessment - Tricuspid valve regurgitation peak velocity (time frame: up to 72 hours). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2021; AzTrials last refreshed its copy on 8 Nov 2026.