Randomized Controlled Trials in Pediatric Critical Care: a Scoping Review.
Duffett M, Choong K, Cupido C, Hartling L, Menon K, Thabane L, Cook DJ.
Aims & objectives
The purpose of this review was to systematically identify and characterize randomized controlled trials (RCTs) in pediatric critical care. We hypothesize that RCTs in critically ill children are limited in number, size and methodologic quality.
We searched MEDLINE, EMBASE, LILACS and CENTRAL (from inception to July 1, 2012). We included published RCTs and quasi-randomized trials that administered any intervention to children in a pediatric critical care unit. We excluded trials enrolling exclusively newborns, cross-over trials and those only published as abstracts. We used no language restrictions. Pairs of reviewers independently screened studies for eligibility and abstracted data. Discrepancies were resolved by consensus.
We included 226 RCTs out of 7280 unique citations screened: 39 (17.3%) were multicentered and 10 (4.4%) were multinational. The most frequently studied populations were mixed critically ill (43.4%), post-operative cardiac surgery (16.4%) and bronchiolitis (7.1%). The most frequently evaluated interventions were medications (59.7%), devices (10.6%), nutrition (9.3%) and mechanical ventilation (8.0%). Almost half, 105 (46.5%), reported blinding. Of the 93 (41.2%) trials that reported an a priori sample size, 32 (34.4%) were stopped early and 20 (21.5%) were stopped for futility, funding or recruitment problems. The median number of children randomized per trial was 47.5 and varied from 6 to 1199. Of the 133 (58.9%) trials reporting the mean age children enrolled, the mean was 4.3 years and varied from 1 month to 14.3 years. Of the 135 (59.7%) trials reporting mortality outcomes, the median mortality rate was 6.4%, varying from 0% to 88.2%. The frequency of RCT publication increased at a mean rate of 1.2 RCT/year (p<0.001) from 1988 to 2011, but the median sample size did not change significantly (p=0.31).
The majority of RCTs in pediatric critical care focused on medications, were single-centered and of variable methodological quality. The number of published pediatric critical care trials is increasing but the sample size is not. Significant challenges still exist in completing these studies.