Neurodevelopmental Follow-up of Children whose Mothers Participated in the ASPIRIN Study
BACKGROUND: Neurodevelopmental delays affect millions of children worldwide, but such delays are more prevalent in low- and middle-income countries (LMICs). The Global Network ASPIRIN Trial is a randomized, placebo-controlled trial implemented in seven LMICs to determine if low dose aspirin (LDA) taken during pregnancy can reduce preterm birth and other pregnancy-related problems that can negatively impact neurodevelopmental status of offspring. GAP: The ASPIRIN Trial demonstrated that LDA administered antenatally decreases the rate of preterm birth, preterm hypertensive disorders of pregnancy, and perinatal mortality. However, a follow-up study is required to determine the impact of antenatal LDA exposure on neurodevelopmental status of offspring when measured at about 3 years of age. HYPOTHESES: Primary Hypothesis: Children exposed antenatally to LDA will have scores on Bayley Scales of Infant Development-III (BSID-III) examination at 36 months of life (+/- 3 months) that are not inferior to their peers who were not exposed; and conditional on showing non-inferiority, children exposed antenatally to low dose aspirin will have higher scores on the BSID-III examination compared to their peers who were not exposed. Secondary Hypothesis: Children exposed antenatally to low dose aspirin will have similar scores on the Ages & Stages-3 Questionnaire (ASQ-3); and conditional on showing non-inferiority, children exposed antenatally to low dose aspirin will have higher scores on this examination compared to their peers who were not exposed. METHODS: A prospective masked matched cohort study will be implemented at 6 LMIC sites to assess neuro-developmental status of 620 ASPIRIN Trial offspring between 33 and 39 months of age who are equally split between a group whose mothers took LDA in the ASPIRIN Trial and a group whose mothers took a placebo. Assessment scores of the two groups will be compared and findings issued for the stated hypotheses. RESULTS: Pending. IMPACT: The study may enlighten governmental policy, parental decision-making and obstetrical counselling. It could encourage scale-up of LDA aspirin use during pregnancy if the LDA exposed children have either higher or non-inferior neurodevelopmental scores compared to the children in the placebo group.