Clinical trial NCT05050045: Echocardiographic Screening of Healthy Neonates for Measuring Pulmonary Artery Pressure
Official title: Echocardiographic Screening of Healthy Neonates for Measuring Pulmonary Artery Pressure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Hypertension of Newborn
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2021-09-20
Enrollment: 110
Sex: ALL
Minimum age (years): 0
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pulmonary artery pressure (PAP) assessment - Tricuspid valve regurgitation peak velocity
timeFrame: up to 72 hours
measure: Pulmonary artery pressure (PAP) assessment - Pulmonary regurgitation peak velocity
timeFrame: up to 72 hours
measure: Pulmonary artery pressure (PAP) assessment - Transductal right-to-left flow peak velocity
timeFrame: up to 72 hours
measure: Pulmonary artery pressure (PAP) assessment - Interventricular septum configuration
timeFrame: up to 72 hours
measure: Pulmonary artery pressure (PAP) assessment - Left ventricle systolic eccentricity index (LV-sEI)
timeFrame: up to 72 hours
measure: Right ventricular performance - Tricuspid annular plane systolic excursion(TAPSE)
timeFrame: up to 72 hours
measure: Right ventricular performance - Myocardial Performance Index (MPI)
timeFrame: up to 72 hours
measure: Right ventricular performance - E/A ratio
timeFrame: up to 72 hours
measure: Left ventricular performance - Ejection fraction
timeFrame: up to 72 hours
measure: Left ventricular performance - E/A ratio
timeFrame: up to 72 hours
measure: Shunts evaluation - Patent Ductus arteriosus
timeFrame: up to 72 hours
measure: Shunts evaluation - Patent Ductus arteriosus
timeFrame: up to 72 hours
measure: Shunts evaluation - Patent Foramen Ovale
timeFrame: up to 72 hours
measure: Shunts evaluation - Patent Foramen Ovale
timeFrame: up to 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Neonatal Intensive Care Unit (NICU) of Alexandria University Maternity Hospital.
Study officials:
affiliation: Faculty of Medicine, Alexandria University, Egypt
name: Rana EO Kandil, MBBCh
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Medicine, Alexandria University, Egypt
name: Aly M Abdel-Mohsen, PhD
role: STUDY_DIRECTOR
affiliation: Faculty of Medicine, Alexandria University, Egypt
name: Marwa M Farag, PhD
role: STUDY_CHAIR
affiliation: Faculty of Medicine, Alexandria University, Egypt
name: Mohamed A Khalifa, MBBCh
role: STUDY_DIRECTOR
References: