Viewing Study NCT03885050


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Study NCT ID: NCT03885050
Status: UNKNOWN
Last Update Posted: 2019-03-21
First Post: 2019-03-16
Is Possible Gene Therapy: False
Has Adverse Events: False

Brief Title: Modified Ross Score for Evaluation of Heart Failure in Children
Sponsor: Assiut University
Organization:

Study Overview

Official Title: Modified Ross Score for Evaluation of Heart Failure in Children With Lower Respiratory Tract
Status: UNKNOWN
Status Verified Date: 2019-03
Last Known Status: NOT_YET_RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: * Identification of Patient those at risk For heart failure associated with lower respiratory tract infection
* Assess the value of Ross score evaluation in lower respiratory tract infection complicated with HF, as a diagnostic tool for severity of HF
Detailed Description: \- Pneumonia in young children remains a global epidemic and a leading cause of death in under-5 children. The annual incidence is approximately 156 million patients worldwide; and pneumonia and its complications led to approximately 0.92 million under-5 deaths in 2015.

In adult patients, cardiac events such as congestive heart failure (CHF) are among the leading complications associated with increased morbidity and mortality, but the association in pediatric patients is not well Established

At Suratthani Hospital, Thailand study therefore investigated the characteristics and factors associated with CHF in under-5 children with pneumonia and respiratory failure (RF). Also, revealed that Pneumonia with respiratory failure is associated with CHF even in healthy children without cardiac risks. The awareness and early recognition of CHF, particularly in male, and bacterial pneumonia is important in order to provide immediate treatment to reduce complications.

\- A diagnosis of heart failure due to right ventricular affection requires a high index of suspicion since symptoms of heart failure such as easy fatiguability and tachypnoea are obscured by the primary pulmonary disease itself.6 The American Heart Association recommends early echocardiographic studies to diagnose pulmonary hypertension in children with obstructive apnea and sickle cell anaemia.2 Systolic pulmonary artery pressure can be estimated by echocardiographic Doppler assessment using definition of mean pulmonary artery pressure of \>25mmHg. A ten-year review of chronic cor pulmonale secondary to respiratory diseases in Ghana was propelled by the fact that early diagnosis can lead to treatment of the respiratory disease, which would then improve a child's cardiac status. Nine cases of chronic cor pulmonale secondary to respiratory diseases were admitted during the period. Three had bronchiectasis as shown in Table 1. Of the three with bronchiectasis, one had congenital lung aplasia; one had a repair of tracheoesophageal atresia at the age of one week. The other was HIV-positive with bronchiectasis secondary to pulmonary tuberculosis.

Children with right heart failure should be investigated for pulmonary cause since early recognition and treatment would improve outcome

Until 1987, the only system available for grading HF in children was the New York Heart Association (NYHA) classification. However, this system was based on limitations to physical activity for adults, which did not translate well for use with children, particularly infants.2 Therefore, we developed a symptom-based classification using more age-appropriate variables. new Ross HF classification from grades I to IV

Several authors have modified Ross scoring system to expand its use to older children.

with all this recent data on factors predictive of outcomes in children with HF that a revision in how we grade symptom severity is required. It also is apparent that age stratification is required to encompass the changes in signs and symptoms that children manifest from infancy to late childhood. A classification system should include the biomarkers, echo parameters of systolic function and mitral or systemic atrioventricular valve (AV) insufficiency, and reflect exercise limitations reflected by feeding and growth in infants and exercise capacity indicated by percentage of predicted maximal oxygen uptake (VO2) in older children. Therefore an age-based Ross classification using the original variables that proved to be sensitive and specific and adding the new evidence-based data.

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: