Echocardiographic Screening of Healthy Neonates for Measuring Pulmonary Artery Pressure
2. november 2021 oppdatert av: 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.
Studieoversikt
Status
Fullført
Detaljert beskrivelse
Healthy newborn infants born in Alexandria University Children's Hospital were studied.
Dynamic changes during the first 72 hours after birth were evaluated.
Studietype
Observasjonsmessig
Registrering (Faktiske)
110
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Alexandria, Egypt, 21131
- Neonatal Intensive Care Unit (NICU) of Alexandria University Maternity Hospital.
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
1 sekund til 6 timer (Barn)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Aly M Abdel-Mohsen, PhD, Faculty of Medicine, Alexandria University, Egypt
- Hovedetterforsker: Rana EO Kandil, MBBCh, Faculty of Medicine, Alexandria University, Egypt
- Studieleder: Mohamed A Khalifa, MBBCh, Faculty of Medicine, Alexandria University, Egypt
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. august 2020
Primær fullføring (Faktiske)
10. august 2021
Studiet fullført (Faktiske)
15. august 2021
Datoer for studieregistrering
Først innsendt
10. september 2021
Først innsendt som oppfylte QC-kriteriene
10. september 2021
Først lagt ut (Faktiske)
20. september 2021
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
4. november 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
2. november 2021
Sist bekreftet
1. november 2021
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 0106488
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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