Bundle-Of-Care vs. Single-Intervention RCTs in Neonatology: Clinical Research in Neonatology-Quo Vadis?

Extreme prematurity is a multi-organ medical emergency. Most high-profile studies in this field are done as single-intervention randomised controlled trials (RCTs), often yielding negative or inconclusive results. Given the complexity of extreme prematurity, we suggest applying future RCTs using a bundle-of-care approach. Such an approach should take into consideration: (a) results from RCTs and meta-analyses demonstrating a positive, albeit non-significant effect of a specific intervention; (b) fundamental physiological aspects unique to the neonatal period; and (c) specific interventions aiming for a common outcome. Complementing and possibly supplanting the gold standard of single-intervention RCTs with a bundle-of-care approach may open new scientific avenues in neonatology.