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).
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 \*NCT02409680\* (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.
Study Type
University of Alabama, Birmingham
Birmingham, Alabama, United States
University of Colorado Health Sciences Center
Denver, Colorado, United States
Christiana Care
Newark, Delaware, United States
Bayley Scales of Infant and Toddler Development, 3rd Edition (Bayley-III) Cognitive Composite Score
Mean of the Bayley-III Cognitive Composite Score (standardized mean 100, SD 15, range 55-155) (lower scores indicating greater impairment)
Time frame: At a single visit occurring between 33-39 months corrected age
Bayley Scales of Infant and Toddler Development, 3rd Edition (Bayley-III) Cognitive Composite Score Less Than 70
Number of participants with the Bayley-III Cognitive Composite score less than 70 (standardized mean 100, SD 15, range 55-155) (lower scores indicating greater impairment)
Time frame: At a single visit occurring between 33-39 months corrected age
Bayley Scales of Infant and Toddler Development, 3rd Edition (Bayley-III) Cognitive Composite Score Less Than 1 Standard Deviation (SD) Below the Mean
Number of participants with the Bayley-III Cognitive Composite score less than 1 SD below the sample mean (standardized mean 100, SD 15, range 55-155) (lower scores indicating greater impairment)
Time frame: At a single visit occurring between 33-39 months corrected age
Bayley Scales of Infant and Toddler Development, 3rd Edition (Bayley-III) Language Composite Score
Mean of the Bayley-III Language Composite Score (standardized mean 100, SD 15, range 45-155) (lower scores indicating greater impairment)
Time frame: At a single visit occurring between 33-39 months corrected age
Bayley Scales of Infant and Toddler Development, 3rd Edition (Bayley-III) Language Composite Score Less Than 70
Number of participants with the Bayley-III Language Composite score less than 70 (standardized mean 100, SD 15, range 45-155) (lower scores indicating greater impairment)
Time frame: At a single visit occurring between 33-39 months corrected age
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
OBSERVATIONAL
Enrollment
666
Boston University
Boston, Massachusetts, United States
Columbia University
New York, New York, United States
University of North Carolina School of Medicine
Chapel Hill, North Carolina, United States
RTI International
Research Triangle Park, North Carolina, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Kinshasa School of Public Health
Kinshasa, Democratic Republic of the Congo
INCAP
Guatemala City, Guatemala
...and 4 more locations
Bayley Scales of Infant and Toddler Development, 3rd Edition (Bayley-III) Language Composite Score Less Than 1 Standard Deviation (SD) Below the Mean
Number of participants with the Bayley-III Language Composite score less than 1 SD below the sample mean (standardized mean 100, SD 15, range 45-155) (lower scores indicating greater impairment)
Time frame: At a single visit occurring between 33-39 months corrected age
Bayley Scales of Infant and Toddler Development, 3rd Edition (Bayley-III) Motor Composite Score
Mean of the Bayley-III Motor Composite Score (standardized mean 100, SD 15, range 45-155) (lower scores indicating greater impairment)
Time frame: At a single visit occurring between 33-39 months corrected age
Bayley Scales of Infant and Toddler Development, 3rd Edition (Bayley-III) Motor Composite Score Less Than 70
Number of participants with the Bayley-III Motor Composite score less than 70 (standardized mean 100, SD 15, range 45-155) (lower scores indicating greater impairment)
Time frame: At a single visit occurring between 33-39 months corrected age
Bayley Scales of Infant and Toddler Development, 3rd Edition (Bayley-III) Motor Composite Score Less Than 1 Standard Deviation (SD) Below the Mean
Number of participants with the Bayley-III Motor Composite score less than 1 SD below the sample mean (standardized mean 100, SD 15, range 45-155) (lower scores indicating greater impairment)
Time frame: At a single visit occurring between 33-39 months corrected age
Ages and Stages Questionnaire, 3rd Edition (ASQ-3) Communication Total Score
Mean of the ASQ Communication Total Score (range 0-60) (lower scores indicating greater impairment)
Time frame: At a single visit occurring between 33-39 months corrected age
Ages and Stages Questionnaire, 3rd Edition (ASQ-3) Communication Total Score Less Than 1 Standard Deviation (SD) Below the Mean
Number of participants with the ASQ Communication Total score less than 1 SD below the sample mean (range 0-60) (lower scores indicating greater impairment)
Time frame: At a single visit occurring between 33-39 months corrected age
Ages and Stages Questionnaire, 3rd Edition (ASQ-3) Gross Motor Total Score
Mean of the ASQ Gross Motor Total Score (range 0-60) (lower scores indicating greater impairment)
Time frame: At a single visit occurring between 33-39 months corrected age
Ages and Stages Questionnaire, 3rd Edition (ASQ-3) Gross Motor Total Score Less Than 1 Standard Deviation (SD) Below the Mean
Number of participants with the ASQ Gross Motor Total score less than 1 SD below the sample mean (range 0-60) (lower scores indicating greater impairment)
Time frame: At a single visit occurring between 33-39 months corrected age
Ages and Stages Questionnaire, 3rd Edition (ASQ-3) Fine Motor Total Score
Mean of the ASQ Fine Motor Total Score (range 0-60) (lower scores indicating greater impairment)
Time frame: At a single visit occurring between 33-39 months corrected age
Ages and Stages Questionnaire, 3rd Edition (ASQ-3) Fine Motor Total Score Less Than 1 Standard Deviation (SD) Below the Mean
Number of participants with the ASQ Fine Motor Total score less than 1 SD below the sample mean (range 0-60) (lower scores indicating greater impairment)
Time frame: At a single visit occurring between 33-39 months corrected age
Ages and Stages Questionnaire, 3rd Edition (ASQ-3) Problem Solving Total Score
Mean of the ASQ Problem Solving Total Score (range 0-60) (lower scores indicating greater impairment)
Time frame: At a single visit occurring between 33-39 months corrected age
Ages and Stages Questionnaire, 3rd Edition (ASQ-3) Problem Solving Total Score Less Than 1 Standard Deviation (SD) Below the Mean
Number of participants with the ASQ Problem Solving Total score less than 1 SD below the sample mean (range 0-60) (lower scores indicating greater impairment)
Time frame: At a single visit occurring between 33-39 months corrected age
Ages and Stages Questionnaire, 3rd Edition (ASQ-3) Personal Social Total Score
Mean of the ASQ Personal Social Total Score (range 0-60) (lower scores indicating greater impairment)
Time frame: At a single visit occurring between 33-39 months corrected age
Ages and Stages Questionnaire, 3rd Edition (ASQ-3) Personal Social Total Score Less Than 1 Standard Deviation (SD) Below the Mean
Number of participants with the ASQ Personal Social Total score less than 1 SD below the sample mean (range 0-60) (lower scores indicating greater impairment)
Time frame: At a single visit occurring between 33-39 months corrected age