ASPIRIN: Neurodevelopmental Follow-up Trial
Condition: Neurodevelopmental Abnormality
MeSH terms: Congenital Abnormalities
Study type: Observational

Summary: 
      A total of 620 children will be enrolled in this study from six sites in sub-Saharan Africa,
      South Asia, and Latin America. Half of the children's mothers will have taken aspirin and
      half will have taken placebo. This will allow the researchers to compare results of the two
      groups of children and determine if children exposed antenatally to low dose aspirin will
      have scores on the Bayley Scales of Infant Development-III (BSID-III) examination at 36
      months of life (+/-3months) that are not inferior to the child's peers who were not exposed
      (i.e., by no more than a margin of 4 points).
    

Detailed description: 
      An estimated 250 million children under the age of 511 worldwide are at risk for not
      achieving their developmental potential; 52.9 million children under five years of age in
      low- and middle-income country (LMIC) settings have neurodevelopmental delays. Compounding
      the issue is preterm birth (more common in LMICs) which has consistently been identified as a
      cause of neurodevelopmental delay. A recent review reported that out of the estimated 13
      million preterm infants who survive beyond the first month, 0.9 million will suffer long term
      neurodevelopmental impairment, with 345,000 moderately or severely affected. This burden
      places a significant strain on the families, healthcare systems and societies that provide
      care for these children. Data from other Global Network participating sites (Guatemala,
      Democratic Republic of Congo, Zambia and Pakistan) also found strikingly high rates of
      stunting ranging from 44% to 66%, among infants and toddlers. Poverty additionally
      contributes to the attainment of optimal neurodevelopment. As such, any study of
      neurodevelopment should at least document these potential confounders.

      Aspirin has been shown to predominantly affect both the COX-1 pathway which is involved in
      thrombosis and the COX-2 pathway, which affects inflammation through the production of
      Aspirin Triggered Lipoxins. More specifically, aspirin has been shown to inhibit the
      production of IL-6, IL-1B, CRP and TNF-α all of which have been shown to negatively affect
      child neurodevelopment and be involved in preeclampsia and preterm birth.

      This will be a prospective masked matched cohort study of children between 33 and 39 months
      (mean 36 months) of age whose mothers were randomized in the ASPIRIN trial (1:1
      Aspirin-Placebo), who will be evaluated using the BSID-III. Additionally, the Family
      Resources and Context questionnaire will be performed to adjust for the local context and the
      ASQ-3 will be administered as a secondary screen. Recognizing the significant role that
      preterm birth plays in neurodevelopment, the investigators will include 100 (50 in each
      group) children who were delivered before 37 weeks.
    

Intervention name(s): Aspirin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participant's mothers were administered 81mg of Aspirin throughout their pregnancy with the participant.; Participant's mothers were administered placebo throughout their pregnancy with the participant.
Intervention MeSH terms: Aspirin
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The study population will consist of approximately 620 children, between 33 and 39 months
        of age, whose mothers were included in the ASPIRIN trial.
      
Keywords: Pre-eclampsia; Low Dose Aspirin; ASPIRIN Trail; NICHD Global Network; Global Network; ASPRIN Follow Up; BSID-III; Family Resources and Context; ASQ-36; Neurodevelopmental delays; hypertensive disorders of pregnancy (HDP); Pre-term birth; LDA