Echocardiographic Screening of Healthy Neonates for Measuring Pulmonary Artery Pressure
2. november 2021 opdateret af: Marwa Mohamed Farag
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.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
Healthy newborn infants born in Alexandria University Children's Hospital were studied.
Dynamic changes during the first 72 hours after birth were evaluated.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
110
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
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Alexandria, Egypten, 21131
- Neonatal Intensive Care Unit (NICU) of Alexandria University Maternity Hospital.
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
1 sekund til 6 timer (Barn)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
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.
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Pulmonary artery pressure (PAP) assessment - Tricuspid valve regurgitation peak velocity
Tidsramme: 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) |
up to 72 hours
|
|
Pulmonary artery pressure (PAP) assessment - Pulmonary regurgitation peak velocity
Tidsramme: 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)
|
up to 72 hours
|
|
Pulmonary artery pressure (PAP) assessment - Transductal right-to-left flow peak velocity
Tidsramme: up to 72 hours
|
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
Tidsramme: 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.
|
up to 72 hours
|
|
Pulmonary artery pressure (PAP) assessment - Left ventricle systolic eccentricity index (LV-sEI)
Tidsramme: 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.
|
up to 72 hours
|
|
Right ventricular performance - Tricuspid annular plane systolic excursion(TAPSE)
Tidsramme: up to 72 hours
|
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)
Tidsramme: up to 72 hours
|
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
Tidsramme: 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.
|
up to 72 hours
|
|
Left ventricular performance - Ejection fraction
Tidsramme: up to 72 hours
|
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
Tidsramme: 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
|
up to 72 hours
|
|
Shunts evaluation - Patent Ductus arteriosus
Tidsramme: up to 72 hours
|
Size will be evaluated in short axis parasternal view
|
up to 72 hours
|
|
Shunts evaluation - Patent Ductus arteriosus
Tidsramme: up to 72 hours
|
Direction will be evaluated in short axis parasternal view using color Doppler
|
up to 72 hours
|
|
Shunts evaluation - Patent Foramen Ovale
Tidsramme: up to 72 hours
|
Size will be evaluated in be viewed in subcostal view
|
up to 72 hours
|
|
Shunts evaluation - Patent Foramen Ovale
Tidsramme: up to 72 hours
|
Direction will be evaluated in subcostal view using color Doppler
|
up to 72 hours
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Aly M Abdel-Mohsen, PhD, Faculty of Medicine, Alexandria University, Egypt
- Ledende efterforsker: Rana EO Kandil, MBBCh, Faculty of Medicine, Alexandria University, Egypt
- Studieleder: Mohamed A Khalifa, MBBCh, Faculty of Medicine, Alexandria University, Egypt
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. august 2020
Primær færdiggørelse (Faktiske)
10. august 2021
Studieafslutning (Faktiske)
15. august 2021
Datoer for studieregistrering
Først indsendt
10. september 2021
Først indsendt, der opfyldte QC-kriterier
10. september 2021
Først opslået (Faktiske)
20. september 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
4. november 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
2. november 2021
Sidst verificeret
1. november 2021
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 0106488
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Studerer et amerikansk FDA-reguleret enhedsprodukt
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