Child developmental follow up in obstetric RCTs: a unique opportunity.

Fernandes, Michelle (2020) Child developmental follow up in obstetric RCTs: a unique opportunity. British Journal of Obstetrics and Gynaecology, 127 (4), 518. (doi:10.1111/1471-0528.16050).

Record type: Article

Abstract

For many obstetric-outcome focused randomised controlled trials (RCTs), the long-term developmental follow up of offspring is often not prioritised beyond the neonatal period. Obstetric RCTs, however, offer a unique opportunity to answer nuanced, hypothesis-focused questions about child development, in a manner in which observational birth cohorts, including those specific to child development, cannot. Often, by controlling for certain significant influences associated with adverse obstetric outcomes, such as maternal illness, and socio-economic status, in their design, these RCTs also inherently control for many factors evidenced to be associated with adverse child developmental outcomes.

A good example of such an effort is provided in this issue’s paper by Ellingsen et al. (BJOG 2020;127:508–17). While the RCT's primary objective was to determine whether a regular, moderate intensity exercise intervention during pregnancy could prevent pregnancy complications such as gestational diabetes, the follow-up sample allowed the authors to test the effect of regular antenatal exercise on child developmental outcomes at 18 months and 7 years of age. Moreover, this follow up permitted the investigation of a question which, though nuanced, may not necessarily be considered as important as current priority topics in child development research such as child malnutrition, infectious diseases, and poverty (Richter et al. Lancet 2017;389:103–18). The public health message of such work cannot be underestimated and will, I hope, reassure pregnant women about the safety of regular, moderate intensity exercise during pregnancy in the context of their children’s developmental abilities.

Well-conducted obstetric RCTs are more likely than non-randomised studies to produce similar comparison groups, and are therefore particularly suited to estimating the effects of antenatal interventions, including on the developing brain whose most sensitive period is during the first 1000 days of life. As a paediatrician and a researcher in international early child development, I am acutely aware of the technical and logistical challenges of comprehensive, standardised neurodevelopmental assessments. I commend the authors of this paper for assessing multiple dimensions of child development, including motor, language, and social skills, executive function and emotional/behavioural problems, in children aged 7 years. The authors chose to utilise the 90th percentile cut-off in their own control group to characterise problem scores, rather than using the Five to Fifteen’s scales' Swedish references (Trillingsgaard et al. Eur Child Adolesc Psychiatry 2004;13:39–63). It is unfortunate that there is a lack of international standards for child development testing. Although international standards exist to monitor growth in utero and during early childhood (Papageorghiou et al. Lancet 2014;384:869–79; WHO Multicentre Growth Reference Study, and deOnis. Acta Paediatr 2006;95:76–85), no comparable standards as yet exist for child development: researchers and clinicians must therefore select one among many region-specific references, or create their own set of norms. Such un-standardised practice results in a plethora of references with little cross-population applicability, confounding true comparisons between studies and raising questions about the validity of findings; a limitation that even well-conducted RCTs cannot overcome.

Despite these challenges, the long-term developmental follow up of children enrolled in obstetric RCTs provides unique opportunities to answer nuanced questions of scientific, clinical, and public interest which may not otherwise be addressed, as elegantly demonstrated in this paper by Ellingsen et al.

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