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Echocardiographic Screening of Healthy Neonates for Measuring Pulmonary Artery Pressure

NCT ID: NCT05050045

Last Updated: 2021-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

110 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-01

Study Completion Date

2021-08-15

Brief Summary

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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

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Healthy newborn infants born in Alexandria University Children's Hospital were studied. Dynamic changes during the first 72 hours after birth were evaluated.

Conditions

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Pulmonary Hypertension of Newborn

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

0 Minutes

Maximum Eligible Age

6 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Marwa Mohamed Farag

OTHER

Sponsor Role lead

Responsible Party

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Marwa Mohamed Farag

Lecturer in Pediatrics, Faculty of Medicine

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Rana EO Kandil, MBBCh

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine, Alexandria University, Egypt

Aly M Abdel-Mohsen, PhD

Role: STUDY_DIRECTOR

Faculty of Medicine, Alexandria University, Egypt

Marwa M Farag, PhD

Role: STUDY_CHAIR

Faculty of Medicine, Alexandria University, Egypt

Mohamed A Khalifa, MBBCh

Role: STUDY_DIRECTOR

Faculty of Medicine, Alexandria University, Egypt

Locations

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

Alexandria, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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0106488

Identifier Type: -

Identifier Source: org_study_id