The multiple negative randomized controlled trials in perinatology--why?

Semin Perinatol. 2003 Aug;27(4):343-50. doi: 10.1016/s0146-0005(03)00042-9.


Many of the multicenter trials in perinatal medicine have been negative in that they have shown no benefit for the intervention relative to the control. Although a negative trial can improve patient care by the avoidance of an unnecessary treatment, most trials are designed with the intent of the intervention improving outcomes. We selectively reviewed a number of recent trials in order to identify why the trials were negative. In general, the preliminary information on which the trials were based, which was a small trial or a meta-analysis of multiple small trials, was not robust or predictive. The weak preliminary information together with limited numbers of patients, problematic primary outcomes and a poor understanding of the biology of neonatal diseases has limited the ability to reliably design trials with positive outcomes.

Publication types

  • Review

MeSH terms

  • Humans
  • Infant, Newborn
  • Infant, Premature / growth & development*
  • Infant, Very Low Birth Weight / growth & development*
  • Multicenter Studies as Topic / methods*
  • Multicenter Studies as Topic / standards
  • National Institutes of Health (U.S.)
  • Perinatology / methods*
  • Perinatology / standards
  • Randomized Controlled Trials as Topic / methods*
  • Randomized Controlled Trials as Topic / standards
  • Research Design / standards
  • United States