Childhood outcomes after maternal antenatal sildenafil treatment for severe early-onset fetal growth restriction: a randomized trial (STRIDER NZAus)

• Published in: Journal of perinatology 2024-03, Vol.44 (3), p.396-403
• Main Authors: McKinlay, Christopher J. D., Anderson, Chad, Cheong, Jeanie L. Y., Gordon, Adrienne, Harris, Sarah L., Hurrion, Elizabeth M., Ireland, Susan, Koorts, Pieter, Lui, Kei, Mackay, Laura, Oakes-Ter Bals, Mariska, Opie, Gillian, Sharp, Mary, Groom, Katie M.
• Format: Article
• Language: English
• Subjects: 692/308/409; 692/700/1720; Age; Child; Childhood; Children; Clinical outcomes; Clinical trials; Cognition; Cognitive ability; Deafness; Delay; Developmental disabilities; Emotional behavior; Female; Fetal Growth Retardation - drug therapy; Fetuses; Gestational Age; Growth disorders; Humans; Impairment; Medicine; Medicine & Public Health; Pediatric Surgery; Pediatrics; Pregnancy; Prenatal development; Sildenafil; Sildenafil Citrate - therapeutic use; Survival
• ISSN: 0743-8346; 1476-5543
• DOI: 10.1038/s41372-023-01838-7

In this follow-up at 2.5 years of children from the STRIDER NZAus Trial ( N  = 112), in which women with singleton pregnancies affected by severe early fetal growth restriction were randomized to sildenafil citrate 75 mg daily or placebo until 32 weeks, there was no difference between groups in survival without neurosensory impairment, defined as any of cerebral palsy, deafness, blindness, cognitive delay (Bayley III cognition or language score >1 SD below mean) or motor delay: 30/56[54%] vs. 34/56[61%]; aOR = 0.74, 95%CI: 0.31, 1.77. However, children exposed to sildenafil appeared to be more likely to have cognitive delay (13/45[29%] vs. 4/40[10%]; aOR = 3.71, 95% CI: 1.01, 13.63) but less likely to have emotional-behavioural difficulties (2/43[5%] vs. 8/38[21%]; aOR = 0.19, 95%CI: 0.03, 1.00). Conclusion: maternal sildenafil treatment for severe early-onset FGR was not associated with altered survival free of neurosensory impairment at 2.5 years’ corrected age.