ASPIRIN: Neurodevelopmental Follow-up Trial
Completed · Has a placebo group
Conditions studied: Neurodevelopmental Abnormality
In brief
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).
Key facts
- Study ID
- NCT04888377
- Run by
- NICHD Global Network for Women's and Children's Health
- People needed
- 666
- Starts
- 2021-09-01
- Expected to finish
- 2022-06-15
- Last updated by the study team
- 2024-10-21
Who can join
Age: 3 and older, up to 3. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- The child does not meet the inclusion criteria.
Where it is running
- University of Alabama, Birmingham — Birmingham, Alabama, United States
- University of Colorado Health Sciences Center — Denver, Colorado, United States
- Christiana Care — Newark, Delaware, United States
- 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
- Jawaharlal Nehru Medical College — Belagavi, India
- Lata Medical Research Foundation — Nagpur, India
- Aga Khan University — Karachi, Pakistan
- University Teaching Hospital — Lusaka, Zambia
Full record on ClinicalTrials.gov
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