Ten-year follow-up of a randomised trial of drainage, irrigation and fibrinolytic therapy (DRIFT) in infants with post-haemorrhagic ventricular dilatation.

BACKGROUND

The drainage, irrigation and fibrinolytic therapy (DRIFT) trial, conducted in 2003-6, showed a reduced rate of death or severe disability at 2 years in the DRIFT compared with the standard treatment group, among preterm infants with intraventricular haemorrhage (IVH) and post-haemorrhagic ventricular dilatation.

OBJECTIVES

To compare cognitive function, visual and sensorimotor ability, emotional well-being, use of specialist health/rehabilitative and educational services, neuroimaging, and economic costs and benefits at school age.

DESIGN

Ten-year follow-up of a randomised controlled trial.

SETTING

Neonatal intensive care units (Bristol, Katowice, Glasgow and Bergen).

PARTICIPANTS

Fifty-two of the original 77 infants randomised.

INTERVENTIONS

DRIFT or standard therapy (cerebrospinal fluid tapping).

MAIN OUTCOME MEASURES

Primary - cognitive disability. Secondary - vision; sensorimotor disability; emotional/behavioural function; education; neurosurgical sequelae on magnetic resonance imaging; preference-based measures of health-related quality of life; costs of neonatal treatment and of subsequent health care in childhood; health and social care costs and impact on family at age 10 years; and a decision analysis model to estimate the cost-effectiveness of DRIFT compared with standard treatment up to the age of 18 years.

RESULTS

By 10 years of age, 12 children had died and 13 were either lost to follow-up or had declined to participate. A total of 52 children were assessed at 10 years of age (DRIFT,

LIMITATIONS

The main limitations are the sample size of the trial and that important characteristics were unbalanced at baseline and at the 10-year follow-up. Although the analyses conducted here were prespecified in the analysis plan, they had not been prespecified in the original trial registration.

CONCLUSIONS

DRIFT improves cognitive function when taking into account birthweight, grade of IVH and gender. DRIFT is probably effective and, given the reduction in the need for special education, has the potential to be cost-effective as well. A future UK multicentre trial is required to assess efficacy and safety of DRIFT when delivered across multiple sites.

TRIAL REGISTRATION

Current Controlled Trials ISRCTN80286058.

FUNDING

This project was funded by the NIHR Health Technology Assessment programme and will be published in full in

Déclaration de conflit d'intérêts

No competing interests were declared.