STRIDER NZAus childhood outcomes study
STRIDER stands for Sildenafil TheRapy In Dismal prognosis Early onset intrauterine growth Restriction. The Childhood Outcome Study is an early childhood follow-up study to the STRIDER NZAus, a placebo-controlled randomised trial of antenatal sildenafil therapy for severe, early-onset growth restriction.
What is the aim of STRIDER NZAus Childhood Outcome Study?
The STRIDER NZAus Childhood Outcome Study followed up on the cohort of surviving children born to mothers who participated in the STRIDER NZAus trial.
The study aimed to determine whether any benefit (or harm) from receiving antenatal sildenafil therapy as a newborn is sustained or developed throughout childhood.
Our primary hypothesis is that at 2.5 years corrected age, children whose mothers received antenatal sildenafil therapy will have improved survival and neurodevelopmental outcomes compared with those who received placebo.
Why is the study important?
If sildenafil is shown to be effective for the treatment of early onset intrauterine growth restriction (the most severe form of IUGR), its use could be extended to the later stages of pregnancy. This study will generate important Australasian data on neurodevelopmental and health outcomes of children with severe preterm IUGR.
The results are also relevant to other areas of perinatal care as sildenafil is increasingly used in pregnancy and in the management of newborns with very little knowledge of fetal, neonatal and long-term health.
Follow-up of STRIDER NZAus children through childhood will provide essential and reliable safety and outcome data to consider before any extension of sildenafil use in pregnancy and to allow further investigation into its therapeutic potential.
How will children be assessed?
Children in the study were assessed at 2 to 3 years corrected age by a paediatrician and a psychologist:
- The paediatric review included measurement of growth, blood pressure, movement and reflexes, a hearing and vision assessment, and questions about general health and medication use.
- A psychologist or developmental assessor conducted a Bayley III exam (where this has not been conducted as part of the child’s routine follow-up).
- Parents were asked to complete a set of questionnaires about the child’s behaviour, health and home life (including the BRIEF-P, CBCL and ITQOL questionnaires)
How do I find out more?
The follow-up study is now completed, and publication is in preparation.
For more information, email the study team at stridernzaus@auckland.ac.nz