CompletedNot Applicable

ASPIRIN: Neurodevelopmental Follow-up Trial

United States666 participantsStarted 2021-09-01

Plain-language 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).

Who can participate

Age range33 Months – 39 Months

SexALL

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Inclusion Criteria: * Mother was enrolled in the GN ASPIRIN trial * Mother consented to be recontacted * Child's parents or guardians are willing and able to give consent * Child is between 33-39 months of age * Child does not have significant congenital anomaly (blind or deaf) that would affect them from completing study assessments * Child does not have other medical conditions that would preclude the child from completing study assessments. Exclusion Criteria: * The child does not meet the inclusion criteria.

What they're measuring

Bayley Scales of Infant and Toddler Development, 3rd Edition (Bayley-III) Cognitive Composite Score

Timeframe: At a single visit occurring between 33-39 months corrected age

Trial details

NCT IDNCT04888377

SponsorNICHD Global Network for Women's and Children's Health

Sponsor typeNETWORK

Study typeOBSERVATIONAL

Primary completion2022-06-15

Results submitted2024-01-24

View on ClinicalTrials.gov More Neurodevelopmental Abnormality trials