The Importance of Randomized Controlled Trials in Pediatric Cardiology
- Author Affiliations: Nemours Cardiac Center, A. I. duPont Hospital for Children, Wilmington, Delaware; Jefferson Medical College, Philadelphia, Pennsylvania.
- Corresponding Author: Samuel S. Gidding, Nemours Cardiac Center, 1600 Rockland Rd, Wilmington, DE 19803 (sgidding{at}nemours.org).
Since this article does not have an abstract, we have provided the first 150 words of the full text.
- KEYWORDS:
- CARDIOLOGY
- CHILD
- HEART DISEASES
- PATIENT SELECTION
- PEDIATRICS
- QUALITY OF LIFE
- RANDOMIZED TRIALS
- RESEARCH
Experience with randomized controlled clinical trials in pediatric cardiology is limited. Perhaps the most cited article in the field had a sample size of 1, a baby with transposition of the great arteries who successfully underwent balloon dilation of a patent foramen ovale.1 When this procedure was found to improve survival from a median of less than a week to several years, the immediate challenge to clinicians was not to replicate the finding by a randomized trial but to determine how best to manage a living child with an oxygen saturation of 60% to 70% and persistent complex anatomical defects.
Within 25 years and incorporating many technical innovations into diagnosis and management, more than 95% of children born with this defect survived an arterial switch procedure with little morbidity until adulthood.2-3 Along the path to these results, many treatment centers simply converted from performing the conventional …
