Drainage, irrigation and fibrinolytic therapy (DRIFT) for posthaemorrhagic ventricular dilatation: 10-year follow-up of a randomised controlled trial

Abstract

Background: Progressive ventricular dilatation after intraventricular haemorrhage (IVH) in preterm infants has a very high risk of severe disability and death. Drainage, irrigation and fibrinolytic therapy (DRIFT), in a randomised controlled trial (RCT), reduced severe cognitive impairment at 2 years.

Objective: To assess if the cognitive advantage of DRIFT seen at 2 years persisted until school age.

Participants: The RCT conducted in four centres recruited 77 preterm infants with IVH and progressive ventricular enlargement over specified measurements. Follow-up was at 10 years of age.

Intervention: Intraventricular injection of a fibrinolytic followed by continuous lavage, until the drainage was clear, and standard care consisting of control of expansion by lumbar punctures and if expansion persisted via a ventricular access device.

Primary outcome: Cognitive quotient (CQ), derived from the British Ability Scales and Bayley III Scales, and survival without severe cognitive disability.

Results: Of the 77 children randomised, 12 died, 2 could not be traced, 10 did not respond and 1 declined at 10-year follow-up. 28 in the DRIFT group and 24 in the standard treatment group were assessed by examiners blinded to the intervention. The mean CQ score was 69.3 (SD=30.1) in the DRIFT group and 53.7 (SD=35.7) in the standard treatment group (unadjusted p=0.1; adjusted p=0.01, after adjustment for the prespecified variables sex, birth weight and IVH grade). Survival without severe cognitive disability was 66% in the DRIFT group and 35% in the standard treatment group (unadjusted p=0.019; adjusted p=0.003).

Conclusion: DRIFT is the first intervention for posthaemorrhagic ventricular dilatation to objectively demonstrate sustained cognitive improvement.

Trial registration number: ISRCTN80286058.

Keywords: intraventricular haemorrhage; neonatal; neurodevelopment; post-haemorrhagic ventricular dilatation; preterm.

Figure 1

Drainage, irrigation and fibrinolytic therapy (DRIFT) participant flow.

Figure 2

Cognitive quotient, by trial allocation. The box plot indicates the median (central blue line in the box), mean (red dashed line), 25th percentile (bottom line of the box), 75th percentile (top line of the box), and the whiskers for the minimum and maximum values (excluding outliers). The diamonds beyond these whiskers are the outliers, which are observations that lie at an abnormal distance from other values. Outliers are defined as those higher than 1.5× IQR+75th percentile or lower than 25th percentile−1.5× IQR. DRIFT, drainage, irrigation and fibrinolytic therapy.