Drug versus placebo randomized controlled trials in neonates: A review of ClinicalTrials.gov registry.

ABSTRACT:

Background

Despite specific initiatives and identified needs, most neonatal drugs are still used off-label, with variable dosage administrations and schedules. In high risk preterm and term neonates, drug evaluation is challenging and randomized controlled trials (RCT) are difficult to conduct and even more is the use of a placebo, required in the absence of a reference validated drug to be used as comparator.

Methods

We analyzed the complete ClinicalTrials.gov registry 1) to describe neonatal RCT involving a placebo, 2) to report on the medical context and ethical aspects of placebo use.

Results

Placebo versus drug RCT (n = 146), either prevention trials (n = 57, 39%) or therapeutic interventions (n = 89, 61%), represent more than a third of neonatal trials registere

SUBMITTER: Desselas E 

PROVIDER: S-EPMC5305102 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature