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.
- intraventricular haemorrhage
- post-haemorrhagic ventricular dilatation
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Contributors Study concept and design: KL, AW, DO, SJ, CW, PB, MM, GK, HEM, WH, KA, IP, SW-C. Acquisition, analysis or interpretation of data: KL, SJ, HEM, GK, CW, CLL, MM, DO, GJY, PB, WH, KA, IP, AW, AS-C. Drafting of the manuscript: KL, GJY, AW. Critical revision of the manuscript for important intellectual content: KL, SJ, CLL, GJY, DO, HEM, GK, CW, PB, WH, MM, SW-C, KA, IP, AS-C, AW. Statistical analysis: GJY, PB. Obtained funding: KL, AW, DO, PB, SJ, CW, GK, MM, SW-C, KA, IP. Administrative, technical or material support: KL, AW, SJ, CLL, KA, IP, SW-C. KL and GJY had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Disclaimer The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health. The funding sources had no role in the design and conduct of the study; collection, management, analysis and interpretation of the data; preparation, review or approval of the manuscript; and decision to submit the manuscript for publication.
Competing interests None declared.
Patient consent for publication Not required.
Ethics approval Ethical approval was granted by the NHS Health Research Authority, NRES Committee South West - Central Bristol (14/SW/1078) and by the Faculty of Psychology Research Ethics Committee (University of Warsaw). Parents gave written informed consent. The children gave their assent for follow-up.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Data are available upon reasonable request. Individual participant data that underlie the results reported in this article will be available, after deidentification (text, tables, figures and appendices), to investigators whose proposed use of the data has been approved by an independent review committee ('learned intermediary') identified for this purpose. The data may be used for individual participant data meta-analysis. Proposals should be directed to Karen.Luyt@bristol.ac.uk. Proposals may be submitted up to 5 years following article publication. To gain access, data requestors will need to sign a data access agreement.
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