Clinical Profile of Neonates Having Patent Ductus Arteriosus

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Brief Title

Clinical Profile of Neonates Having Patent Ductus Arteriosus

Official Title

Clinical Profile of Neonates Diagnosed by Echocardiography as Having Patent Ductus Arteriousus in Assiut University Hospital for Children

Brief Summary

      The study aims to evaluate the clinical presentation and course of PDA diagnosed at neonatal
      period in the neonatology unit of Assiut University Hospital for Children.
    

Detailed Description

      One of the most common cardiovascular problems that prematurely born infants experience early
      in life is patent ductus arteriosus (PDA).

      The ductus arteriosus is a blood vessel that connects the two major arteries, namely the
      aorta and the pulmonary artery, and is essential in maintaining circulation in fetal life.
      After the baby is born and the fetal circulation changes to adult circulation, the ductus
      arteriosus functionally closes between 18 and 24 hours of life (1 ).

      The arterial duct is a fetal blood vessel that is programmed to close shortly after birth. If
      the vessel remains patent beyond 3 months of life (a persistently patent arterial duct) it
      can result in volume loading of the left heart and should be closed either surgically or by a
      catheter-based procedure. A patent arterial duct is common in the newborn, particularly
      premature infants, and can contribute to persistent respiratory problems. (2) Historical
      estimates have placed the incidence of isolated PDA at approximately 0.05% of all live
      births. Isolated PDA accounts for 5% to 10% of congenital heart defects (3) number most
      likely represents the prevalence of a "symptomatic" PDA-that is, one that results in evidence
      of increased pulmonary blood flow, left heart volume overload, elevated PA pressure, murmur,
      etc. With the advent of color Doppler echocardiography, the incidental recognition of
      asymptomatic "silent" ductus has become more common. Some have estimated the prevalence of
      silent PDA among children and adults to be up to 0.5%, far more common than the "symptomatic"
      PDA (4).

      However, in babies born prematurely, the ductus arteriosus often fails to close spontaneously
      and leads to a number of morbidities. it has been shown that in infants born with a birth
      weight of <1000 g, the ductus arteriosus remains open in 66% of infants beyond the first week
      of life. In the extreme premature population born at 24 weeks of gestation, only 13% of
      infants are found to have their ductus closed by the end of the first week (5).This makes PDA
      an important issue from the clinical management perspective in the first few days of life in
      preterm infants.

      It is associated with a number of comorbidities such as necrotising enterocolitis (NEC),
      bronchopulmonary dysplasia and intraventricular haemorrhage (IVH) (6-7).

      The management controversy has mainly focused on when to treat and with what to treat. To
      increase the complexity of m atters, these two aspects of PDA management are not mutually
      exclusive, with the modality of treatment often being dictated by the timing of treatment.
      There have been a large number of published studies, meta-analyses and editorials focusing on
      different aspects of management.(8-9)Regarding the timing of treatment, prophylactic therapy
      has gradually fallen out of favor and neonatal units have shifted towards a more conservative
      approach by treating only the clinically and echocardiographically (ECHO) significant PDA
      (10).However, the big dilemma that still persists among neonatologists is what to use as the
      primary modality of treatment.
    


Study Type

Observational


Primary Outcome

Determine the percentage of cases with PDA admitted to our neonatology unit per year.


Condition

Patent Ductus Arteriosus

Intervention

echocardiography


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

30

Start Date

January 1, 2021

Completion Date

February 2022

Primary Completion Date

January 1, 2022

Eligibility Criteria

        Inclusion Criteria:

        - 1- Neonatal period (0-28 days) including fullterm and preterm infants for whom
        echocardiography is indicated.

        2- Absence of other congenital cardiac defects.

        Exclusion Criteria:

          -  PDA associated with other cardiac anomalies.
      

Gender

All

Ages

N/A - 28 Days


Contacts

, 01016940909, [email protected]



Administrative Informations


NCT ID

NCT04672629

Organization ID

PDA in neonatology


Responsible Party

Principal Investigator

Study Sponsor

Assiut University


Study Sponsor

, , 


Verification Date

December 2020