NCT03885050

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2019

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 16, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 21, 2019

Completed
8 months until next milestone

Study Start

First participant enrolled

November 1, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
Last Updated

March 21, 2019

Status Verified

March 1, 2019

Enrollment Period

7 months

First QC Date

March 16, 2019

Last Update Submit

March 20, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • The mean score in the study population

    Modified Ross Score For Evaluation of Heart Failure in Children with Lower Respiratory Tract Infection Admitted To Assiut University Pediatric Hospital

    1 hour

Interventions

modified score used for evaluation of heart failure in children, as a diagnostic tool for severity of heart failure

Eligibility Criteria

Age1 Month - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Infants and children around age of (1month to 18 years old) admitted in the Intensive Care Unit and Intermediate Care Unit in Assiut Pediatric Hospital in a period of 6 months

You may qualify if:

  • Children with respiratory lower tract infection

You may not qualify if:

  • Patients with past history of cardiac disease
  • Patients with past history of renal disease.
  • Patient less than 1 month
  • Parent refusal to participate the research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Laer S, Mir TS, Behn F, Eiselt M, Scholz H, Venzke A, Meibohm B, Weil J. Carvedilol therapy in pediatric patients with congestive heart failure: a study investigating clinical and pharmacokinetic parameters. Am Heart J. 2002 May;143(5):916-22. doi: 10.1067/mhj.2002.121265.

    PMID: 12040358BACKGROUND
  • Ross RD. The Ross classification for heart failure in children after 25 years: a review and an age-stratified revision. Pediatr Cardiol. 2012 Dec;33(8):1295-300. doi: 10.1007/s00246-012-0306-8. Epub 2012 Apr 5.

    PMID: 22476605BACKGROUND
  • Ross RD, Bollinger RO, Pinsky WW. Grading the severity of congestive heart failure in infants. Pediatr Cardiol. 1992 Apr;13(2):72-5. doi: 10.1007/BF00798207.

    PMID: 1614922BACKGROUND
  • Corrales-Medina VF, Musher DM, Wells GA, Chirinos JA, Chen L, Fine MJ. Cardiac complications in patients with community-acquired pneumonia: incidence, timing, risk factors, and association with short-term mortality. Circulation. 2012 Feb 14;125(6):773-81. doi: 10.1161/CIRCULATIONAHA.111.040766. Epub 2012 Jan 4.

    PMID: 22219349BACKGROUND
  • Musher DM, Rueda AM, Kaka AS, Mapara SM. The association between pneumococcal pneumonia and acute cardiac events. Clin Infect Dis. 2007 Jul 15;45(2):158-65. doi: 10.1086/518849. Epub 2007 Jun 6.

    PMID: 17578773BACKGROUND

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Central Study Contacts

Enas saad, master

CONTACT

Salah Eldin Amry, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

March 16, 2019

First Posted

March 21, 2019

Study Start

November 1, 2019

Primary Completion

May 30, 2020

Study Completion

September 30, 2020

Last Updated

March 21, 2019

Record last verified: 2019-03