NEW YORK (Reuters Health) – A treatment called DRIFT (Drainage, Irrigation, and Fibrinolytic Therapy) may improve developmental outcomes and survival in preterm infants with posthemorrhagic cerebral ventricular dilatation, new research suggests.
Definitive conclusions can’t be drawn as the trial was stopped early, partly due to a higher risk of secondary intraventricular bleeding with DRIFT. But clinically speaking, infants treated with DRIFT were better off two years later than those given standard therapy.
“Premature infants with posthemorrhagic ventricular dilatation have a high rate of severe cognitive and motor disabilities, but no intervention has been shown to improve outcome,” lead author Dr. Andrew Whitelaw, from the University of Bristol Medical School, U.K., and colleagues note.
“Secondary cerebral injury may be caused by free radicals, inflammation, and pressure,” the authors explain. Drainage, irrigation, and fibrinolysis address all these mechanisms and could potentially improve patient outcomes.
As they report in the April issue of Pediatrics, the researchers randomized 77 preterm infants with posthemorrhagic ventricular dilatation to receive DRIFT (n = 39) or standard treatment (n = 38), which included drainage of cerebrospinal fluid to control ventricular expansion.
By two years of corrected age, 3 children in the DRIFT group and 5 in the control group had died, and 18 and 22 in the DRIFT and control groups, respectively, were severely disabled.
Therefore, rates of the primary endpoint – death or severe disability – were 54% with DRIFT versus 71% with standard care (adjusted OR, 0.25).
“Severe cognitive disability was nearly halved” with DRIFT, the authors report. Specifically, 11 survivors in the DRIFT group (31%) had severe cognitive impairment, versus 19 of 33 (58%) in the control group (aOR, 0.17), as measured by the Bayley Mental Development Index. The median Mental Development Index score in the DRIFT group was also better: 68 vs. <50.
DRIFT did not improve rates of sensorimotor disability, however.
The research team comments that their results “raise a difficult dilemma in trial management.” Given that the interim analysis showed increased intracerebral bleeding and no decrease in the need for shunts with DRIFT, “few would have taken responsibility in 2007 for continuing to recruit” to this trial. But today, the authors continue, the two study groups have a difference of more than 18 points on the Mental Development Index score, “which most families and clinicians would rate as important.”
With the caveat that their population was small and the trial was stopped early, the researchers still conclude: “Despite an increase in secondary intraventricular bleeding, DRIFT reduced severe cognitive disability in survivors and overall death or severe disability.”
Reference:
Pediatrics 2010;125:e852-e858.
