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.
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