Randomized trial of drainage, irrigation and fibrinolytic therapy for premature infants with posthemorrhagic ventricular dilatation: developmental outcome at 2 years.
BACKGROUND
Preterm infants who develop posthemorrhagic ventricular dilatation (PHVD) have a high risk of cognitive and motor disability. No clinical intervention has been proven to reduce neurodevelopmental disability in such infants. We investigated whether drainage, irrigation, and fibrinolytic therapy (DRIFT), which aims to lower pressure, distortion, free iron, and cytokines, reduces death or severe disability in PHVD.


METHODS
We randomly assigned 77 preterm infants with PHVD to either DRIFT or standard treatment (ie tapping off cerebrospinal fluid to control excessive expansion). Severe disability was assessed at 2 years' corrected age and included severe sensorimotor disability and cognitive disability (<55 on the Bayley Mental Development Index).


RESULTS
Of 39 infants assigned to DRIFT, 21 (54%) died or were severely disabled versus 27 of 38 (71%) in the standard group (adjusted odds ratio 0.25 [95% confidence interval: 0.08-0.82]). Among the survivors, 11 of 35 (31%) in the DRIFT group had severe cognitive disability versus 19 of 32 (59%) in the standard group (adjusted odds ratio: 0.17 [95% confidence interval: 0.05-0.57]). Median Mental Development Index was 68 with DRIFT and <50 with standard care. Severe sensorimotor disability was not significantly reduced.


CONCLUSIONS
Despite an increase in secondary intraventricular bleeding, DRIFT reduced severe cognitive disability in survivors and overall death or severe disability.
Whitelaw
Andrew
A
Neonatal Medicine, University of Bristol Medical School, Southmead Hospital, Bristol BS10 5NB, United Kingdom. andrew.whitelaw@bristol.ac.uk
Jary
Sally
S
Kmita
Grazyna
G
Wroblewska
Jolanta
J
Musialik-Swietlinska
Ewa
E
Mandera
Marek
M
Hunt
Linda
L
Carter
Michael
M
Pople
Ian
I
D002311:Cardiomyopathy, Dilated / Q000150:complications / Q000175:diagnosis / Q000628:therapy*; D002543:Cerebral Hemorrhage / Q000150:complications / Q000175:diagnosis / Q000628:therapy*; D002557:Cerebrospinal Fluid Shunts / Q000379:methods; D002658:Developmental Disabilities / Q000175:diagnosis / Q000209:etiology* / Q000628:therapy*; D004108:Dilatation, Pathologic; D004322:Drainage / Q000379:methods; D005260:Female; D006801:Humans; D007231:Infant, Newborn; D007234:Infant, Premature; D007235:Infant, Premature, Diseases / Q000175:diagnosis / Q000628:therapy*; D008297:Male; D007507:Therapeutic Irrigation / Q000379:methods; D015912:Thrombolytic Therapy / Q000379:methods; D016896:Treatment Outcome; D018754:Ventricular Dysfunction / Q000150:complications / Q000175:diagnosis / Q000628:therapy*