Outcomes Of Interventional Catheterization In Infants Less Than 3 Months With Critical Congenital Heart Disease

NCT05351125 | Unknown

• 1 other identifier: catheterization in CHD
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

Congenital heart disease is the most common birth defect affecting mostly 1 in 100 births(1), critical congenital heart disease is when there is low systemic cardiac output which requires urgent surgery or catheter intervention in the first year of life(2), in low-income countries CCHD is associated with severe high mortality rate due to low health resources, in high-income countries, CCHD is associated with life-long morbidities and a high burden on the health care systems(1-3)

Conditions

Critical Congenital Heart Disease

Outcome Measures

Primary Outcomes (2)

• the effect of cardiac catheter interventions in infants < 3 months with critical congenital heart disease on morbidity and mortality

  the success rates of urgent cardiac cathetrization Type of procedure. Procedural outcome:

  6 months post catheterization

• Delineation of failure of the procedure and its causes

  failure of cardiac catheterization with urgent referral to surgery

  immediate post procedure up to 1montn

Secondary Outcomes (2)

• Complications of trans catheter intervention

  6 month

• the least and sufficient Procedure time , the radiation time and its side effects

  6 months

Interventions

cardiac catheterization PROCEDURE

catheterization in critical congenital heart disease requiring atrial septostomy or balloon valvuloplastyor PDA stenting

Eligibility Criteria

• Age: 12 Hours - 3 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

All infants less than 3 months of age with critical congenital heart disease requiring urgent cardiac catheter intervention

You may qualify if:

• All infants less than 3 months of age with critical congenital heart disease requiring urgent cardiac catheter intervention including
• Critical valvular aortic stenosis requiring aortic valvuoplasty.
• Pulmonary valvuloplasty for critical valvular pulmonary stenosis.
• PDA stenting in duct dependent congenital cyanotic heart disease.
• Atrial septostomy to enhance atrial mixing (in transposition of great arteries with restrictive or no inter-atrial communication).
• Balloon angioplasty of native coarctation as a palliative measure to stabilize a patient with severely depressed ventricular function.

You may not qualify if:

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• patent ductus arteriosus closure
• percutaneous temporary pacemaker implantation for arrhythmia
• diagnostic catheterization.
• prematurity
• low birth weight
• bleeding diathesis
• sepsis.

Sponsors & Collaborators

• YHAlattar: lead

Related Publications (6)

• Bakker MK, Bergman JEH, Krikov S, Amar E, Cocchi G, Cragan J, de Walle HEK, Gatt M, Groisman B, Liu S, Nembhard WN, Pierini A, Rissmann A, Chidambarathanu S, Sipek A Jr, Szabova E, Tagliabue G, Tucker D, Mastroiacovo P, Botto LD. Prenatal diagnosis and prevalence of critical congenital heart defects: an international retrospective cohort study. BMJ Open. 2019 Jul 2;9(7):e028139. doi: 10.1136/bmjopen-2018-028139.

  PMID: 31270117 BACKGROUND

• Khalil M, Jux C, Rueblinger L, Behrje J, Esmaeili A, Schranz D. Acute therapy of newborns with critical congenital heart disease. Transl Pediatr. 2019 Apr;8(2):114-126. doi: 10.21037/tp.2019.04.06.

  PMID: 31161078 BACKGROUND

• Arth AC, Tinker SC, Simeone RM, Ailes EC, Cragan JD, Grosse SD. Inpatient Hospitalization Costs Associated with Birth Defects Among Persons of All Ages - United States, 2013. MMWR Morb Mortal Wkly Rep. 2017 Jan 20;66(2):41-46. doi: 10.15585/mmwr.mm6602a1.

  PMID: 28103210 BACKGROUND

• Melekoglu AN, Baspinar O. Transcatheter cardiac interventions in neonates with congenital heart disease: A single centre experience. J Int Med Res. 2019 Feb;47(2):615-625. doi: 10.1177/0300060518806111. Epub 2018 Oct 30.

  PMID: 30373426 BACKGROUND

• Alakhfash AA, Jelly A, Almesned A, Alqwaiee A, Almutairi M, Salah S, Hasan M, Almuhaya M, Alnajjar A, Mofeed M, Nasser B. Cardiac Catheterisation Interventions in Neonates and Infants Less Than Three Months. J Saudi Heart Assoc. 2020 May 12;32(2):149-156. doi: 10.37616/2212-5043.1051. eCollection 2020.

  PMID: 33154909 BACKGROUND

• Kumar N, Shaikh AS, Kumari V, Patel N. Echocardiography guided bed side balloon atrial septostomy in dextro transposed great arteries (dTGA) with intact ventricular septum (IVS): A resource limited country experience. Pak J Med Sci. 2018 Nov-Dec;34(6):1347-1352. doi: 10.12669/pjms.346.15792.

  PMID: 30559783 BACKGROUND

MeSH Terms

Interventions

Cardiac Catheterization

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Catheterization; Therapeutics; Investigative Techniques

Central Study Contacts

Yomna Hussein Mohammed Hussein Alattar H Alattar, assisstant lecturer

CONTACT

01008855990; alattaryomna@yahoo.com

Khaled A Sanousy, professor

CONTACT

0 100 306 8421; Khalidelsanousy@yahoo.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 28, 2022
• First Posted: April 28, 2022
• Study Start: June 28, 2022
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2024
• Last Updated: April 28, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share