The University of Southampton
University of Southampton Institutional Repository

Developmental and epilepsy outcomes at age 4 years in the UKISS trial comparing hormonal treatments to vigabatrin for infantile spasms: a multicentre randomised trial

Developmental and epilepsy outcomes at age 4 years in the UKISS trial comparing hormonal treatments to vigabatrin for infantile spasms: a multicentre randomised trial
Developmental and epilepsy outcomes at age 4 years in the UKISS trial comparing hormonal treatments to vigabatrin for infantile spasms: a multicentre randomised trial
Background: Infantile spasms is the name given to a difficult to treat, severe infantile epilepsy with high morbidity. The United Kingdom Infantile Spasms Study (UKISS) showed that absence of spasms on days 13 and 14 after randomisation was more common in infants allocated hormonal treatments than vigabatrin. At 12–14 months, those with no identified aetiology allocated hormonal treatment had better development. However, epilepsy outcome was not affected by treatment allocated. It is not known if the difference in development persists as the infants grow.

Methods: Infants in UKISS were followed up blind to treatment allocation by telephone at a mean age of 4 years using the Vineland Adaptive Behaviour Scales (VABS) and an epilepsy questionnaire.

Findings: 9 of 107 enrolled infants had died. 77 were traced and consented to take part. The median (quartile) VABS scores were 60 (42, 97) for the 39 allocated hormonal treatment and 50 (36, 67) for the 38 allocated vigabatrin (Mann–Whitney U=575; p=0.091; median difference (95% CI): 8 (?1 to 19)). For those with no identified aetiology, VABS scores were 96 (52, 102) for the 21 allocated hormonal treatment and 63 (37, 92) for the 16 allocated vigabatrin (U=98.5; p=0.033; median difference (95% CI): 14 (1 to 42)).The proportions in each treatment group with epilepsy were similar.

Interpretation: For all 77 infants, development and epilepsy outcomes were not significantly different between the two treatment groups. The better development seen at 14 months in those with no identified aetiology allocated hormonal treatment was seen again at 4 years in this study.

0003-9888
382-386
Darke, Katrina
102d57d6-1e96-4de5-921e-959b2e90f70d
Edwards, Stuart W.
a3d25075-5ca4-43fa-8ca5-4932ddd1ee06
Hancock, Eleanor
0aac9197-3944-40b6-a4f4-b3f40bd3b602
Johnson, Anthony L.
f3bbadf1-d1a1-4b09-8d7f-2e9b86aa25dd
Kennedy, Colin R.
7c3aff62-0a86-4b44-b7d7-4bc01f23ec93
Lux, Andrew L.
12152c58-06cc-4751-8c45-4b2b98f0ec30
Newton, Richard W.
b307ba85-c13b-40f7-9c05-ba1b4bafd922
O'Callaghan, Finbar J.K.
2509fcd7-56d9-4f56-9e8b-aeaaccd86aea
Verity, Christopher M.
24c500a4-8efd-4195-b75a-34c49406ff87
Osborne, John P.
db90ab19-3de3-49a8-b82a-b050a1180e6f
Darke, Katrina
102d57d6-1e96-4de5-921e-959b2e90f70d
Edwards, Stuart W.
a3d25075-5ca4-43fa-8ca5-4932ddd1ee06
Hancock, Eleanor
0aac9197-3944-40b6-a4f4-b3f40bd3b602
Johnson, Anthony L.
f3bbadf1-d1a1-4b09-8d7f-2e9b86aa25dd
Kennedy, Colin R.
7c3aff62-0a86-4b44-b7d7-4bc01f23ec93
Lux, Andrew L.
12152c58-06cc-4751-8c45-4b2b98f0ec30
Newton, Richard W.
b307ba85-c13b-40f7-9c05-ba1b4bafd922
O'Callaghan, Finbar J.K.
2509fcd7-56d9-4f56-9e8b-aeaaccd86aea
Verity, Christopher M.
24c500a4-8efd-4195-b75a-34c49406ff87
Osborne, John P.
db90ab19-3de3-49a8-b82a-b050a1180e6f

Darke, Katrina, Edwards, Stuart W., Hancock, Eleanor, Johnson, Anthony L., Kennedy, Colin R., Lux, Andrew L., Newton, Richard W., O'Callaghan, Finbar J.K., Verity, Christopher M. and Osborne, John P. (2010) Developmental and epilepsy outcomes at age 4 years in the UKISS trial comparing hormonal treatments to vigabatrin for infantile spasms: a multicentre randomised trial. Archives of Disease in Childhood, 95 (5), 382-386. (doi:10.1136/adc.2009.160606).

Record type: Article

Abstract

Background: Infantile spasms is the name given to a difficult to treat, severe infantile epilepsy with high morbidity. The United Kingdom Infantile Spasms Study (UKISS) showed that absence of spasms on days 13 and 14 after randomisation was more common in infants allocated hormonal treatments than vigabatrin. At 12–14 months, those with no identified aetiology allocated hormonal treatment had better development. However, epilepsy outcome was not affected by treatment allocated. It is not known if the difference in development persists as the infants grow.

Methods: Infants in UKISS were followed up blind to treatment allocation by telephone at a mean age of 4 years using the Vineland Adaptive Behaviour Scales (VABS) and an epilepsy questionnaire.

Findings: 9 of 107 enrolled infants had died. 77 were traced and consented to take part. The median (quartile) VABS scores were 60 (42, 97) for the 39 allocated hormonal treatment and 50 (36, 67) for the 38 allocated vigabatrin (Mann–Whitney U=575; p=0.091; median difference (95% CI): 8 (?1 to 19)). For those with no identified aetiology, VABS scores were 96 (52, 102) for the 21 allocated hormonal treatment and 63 (37, 92) for the 16 allocated vigabatrin (U=98.5; p=0.033; median difference (95% CI): 14 (1 to 42)).The proportions in each treatment group with epilepsy were similar.

Interpretation: For all 77 infants, development and epilepsy outcomes were not significantly different between the two treatment groups. The better development seen at 14 months in those with no identified aetiology allocated hormonal treatment was seen again at 4 years in this study.

Text
Darke_et_al_adc_2010.pdf - Version of Record
Restricted to Repository staff only
Request a copy

More information

Published date: May 2010

Identifiers

Local EPrints ID: 153027
URI: http://eprints.soton.ac.uk/id/eprint/153027
ISSN: 0003-9888
PURE UUID: 20bad960-8054-4e28-a3d6-4c64104a37be

Catalogue record

Date deposited: 18 May 2010 09:26
Last modified: 14 Mar 2024 01:25

Export record

Altmetrics

Contributors

Author: Katrina Darke
Author: Stuart W. Edwards
Author: Eleanor Hancock
Author: Anthony L. Johnson
Author: Andrew L. Lux
Author: Richard W. Newton
Author: Finbar J.K. O'Callaghan
Author: Christopher M. Verity
Author: John P. Osborne

Download statistics

Downloads from ePrints over the past year. Other digital versions may also be available to download e.g. from the publisher's website.

View more statistics

Atom RSS 1.0 RSS 2.0

Contact ePrints Soton: eprints@soton.ac.uk

ePrints Soton supports OAI 2.0 with a base URL of http://eprints.soton.ac.uk/cgi/oai2

This repository has been built using EPrints software, developed at the University of Southampton, but available to everyone to use.

We use cookies to ensure that we give you the best experience on our website. If you continue without changing your settings, we will assume that you are happy to receive cookies on the University of Southampton website.

×