N/A
N=666
ASPIRIN: Neurodevelopmental Follow-up Trial
Neurodevelopmental Abnormality
Bottom Line
View on ClinicalTrials.gov: NCT04888377 ↗Enrolled (actual)
666
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: Bayley Scales of Infant and Toddler Development, 3rd Edition (Bayley-III) Cognitive Composite Score — 96; 96.8 score on a scale — p=0.25
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Aspirin (Drug); Placebo (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- NICHD Global Network for Women's and Children's Health
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Bayley Scales of Infant and Toddler Development, 3rd Edition (Bayley-III) Cognitive Composite Score |
96; 96.8 | 0.25 |
| SECONDARY Bayley Scales of Infant and Toddler Development, 3rd Edition (Bayley-III) Cognitive Composite Score Less Than 70 |
327; 309; 2; 2 | — |
| SECONDARY Bayley Scales of Infant and Toddler Development, 3rd Edition (Bayley-III) Cognitive Composite Score Less Than 1 Standard Deviation (SD) Below the Mean |
297; 285; 32; 26 | — |
| SECONDARY Bayley Scales of Infant and Toddler Development, 3rd Edition (Bayley-III) Language Composite Score |
101.2; 100.4 | — |
| SECONDARY Bayley Scales of Infant and Toddler Development, 3rd Edition (Bayley-III) Language Composite Score Less Than 70 |
327; 302; 1; 4 | — |
| SECONDARY Bayley Scales of Infant and Toddler Development, 3rd Edition (Bayley-III) Language Composite Score Less Than 1 Standard Deviation (SD) Below the Mean |
290; 273; 38; 33 | — |
| SECONDARY Bayley Scales of Infant and Toddler Development, 3rd Edition (Bayley-III) Motor Composite Score |
99.4; 100.1 | — |
| SECONDARY Bayley Scales of Infant and Toddler Development, 3rd Edition (Bayley-III) Motor Composite Score Less Than 70 |
323; 305; 3; 3 | — |
| SECONDARY Bayley Scales of Infant and Toddler Development, 3rd Edition (Bayley-III) Motor Composite Score Less Than 1 Standard Deviation (SD) Below the Mean |
281; 264; 45; 44 | — |
| SECONDARY Ages and Stages Questionnaire, 3rd Edition (ASQ-3) Communication Total Score |
52; 50.7 | — |
| SECONDARY Ages and Stages Questionnaire, 3rd Edition (ASQ-3) Communication Total Score Less Than 1 Standard Deviation (SD) Below the Mean |
277; 256; 53; 58 | — |
| SECONDARY Ages and Stages Questionnaire, 3rd Edition (ASQ-3) Gross Motor Total Score |
47.8; 48.3 | — |
| SECONDARY Ages and Stages Questionnaire, 3rd Edition (ASQ-3) Gross Motor Total Score Less Than 1 Standard Deviation (SD) Below the Mean |
270; 253; 60; 61 | — |
| SECONDARY Ages and Stages Questionnaire, 3rd Edition (ASQ-3) Fine Motor Total Score |
39.6; 38.3 | — |
| SECONDARY Ages and Stages Questionnaire, 3rd Edition (ASQ-3) Fine Motor Total Score Less Than 1 Standard Deviation (SD) Below the Mean |
255; 246; 75; 68 | — |
| SECONDARY Ages and Stages Questionnaire, 3rd Edition (ASQ-3) Problem Solving Total Score |
40.2; 40.2 | — |
| SECONDARY Ages and Stages Questionnaire, 3rd Edition (ASQ-3) Problem Solving Total Score Less Than 1 Standard Deviation (SD) Below the Mean |
265; 256; 65; 58 | — |
| SECONDARY Ages and Stages Questionnaire, 3rd Edition (ASQ-3) Personal Social Total Score |
45.5; 45.3 | — |
| SECONDARY Ages and Stages Questionnaire, 3rd Edition (ASQ-3) Personal Social Total Score Less Than 1 Standard Deviation (SD) Below the Mean |
273; 252; 57; 62 | — |
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).
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04888377). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.