STRIDER: Phase Two Follow-up
Research type
Research Study
Full title
Follow-up study of infants (aged 2 years’ corrected) born to mothers who took part in STRIDER UK, a multicentre double blind randomised placebo controlled trial.
IRAS ID
208608
Contact name
Andrew Sharp
Contact email
Sponsor organisation
The University of Liverpool
Duration of Study in the UK
4 years, 4 months, 0 days
Research summary
There is currently no effective treatment for severely growth restricted infants whilst still developing in utero. Consequently, outcomes often result in stillbirth or preterm birth. Being born too small and too early can cause both immediate and long-term health problems. STRIDER UK is the MRC EME randomised placebo controlled trial recruiting women with pregnancies complicated by severe growth restriction to investigate whether sildenafil improves fetal growth.
The current study is a follow-up of the STRIDER UK trial to examine the balance of longer term benefits and risks associated with this therapy. All eligible surviving children from the trial will be invited for assessment at 2 - 3 years corrected age. This will allow us to determine the effect of sildenafil on neurodevelopmental and cardiovascular outcomes in infancy in comparison with a placebo controlled group of infants. Importantly, this follow-up will facilitate the maintenance of contact with this well characterised unique cohort as they develop throughout childhood.
REC name
London - Brent Research Ethics Committee
REC reference
16/LO/2225
Date of REC Opinion
21 Dec 2016
REC opinion
Favourable Opinion