Trial Outcomes & Findings for ASPIRIN: Neurodevelopmental Follow-up Trial (NCT NCT04888377)

NCT ID: NCT04888377

Last Updated: 2024-10-21

Results Overview

Mean of the Bayley-III Cognitive Composite Score (standardized mean 100, SD 15, range 55-155) (lower scores indicating greater impairment)

• Recruitment status: COMPLETED
• Target enrollment: 666 participants
• Primary outcome timeframe: At a single visit occurring between 33-39 months corrected age
• Results posted on: 2024-10-21

Participant Flow

Participant milestones

Measure	Aspirin Children of mothers who received 81mg low-dose aspirin daily beginning between 6 weeks 0 days and 13 weeks 6 days, until 37 weeks or delivery.	Placebo Children of mothers who received placebo daily beginning between 6 weeks 0 days and 13 weeks 6 days, until 37 weeks or delivery.
Overall Study STARTED	343	323
Overall Study Completed BSID-III Assessment	330	312
Overall Study COMPLETED	329	311
Overall Study NOT COMPLETED	14	12

Reasons for withdrawal

Measure	Aspirin Children of mothers who received 81mg low-dose aspirin daily beginning between 6 weeks 0 days and 13 weeks 6 days, until 37 weeks or delivery.	Placebo Children of mothers who received placebo daily beginning between 6 weeks 0 days and 13 weeks 6 days, until 37 weeks or delivery.
Overall Study Incomplete Follow-up or No Study Data	1	3
Overall Study Physician Decision	6	6
Overall Study Withdrawal by Subject	7	3

Baseline Characteristics

ASPIRIN: Neurodevelopmental Follow-up Trial

Baseline characteristics by cohort

Measure	Aspirin n=343 Participants Children of mothers who received 81mg low-dose aspirin daily beginning between 6 weeks 0 days and 13 weeks 6 days, until 37 weeks or delivery.	Placebo n=323 Participants Children of mothers who received placebo daily beginning between 6 weeks 0 days and 13 weeks 6 days, until 37 weeks or delivery.	Total n=666 Participants Total of all reporting groups
Age, Continuous	37.5 months STANDARD_DEVIATION 1 • n=5 Participants	37.5 months STANDARD_DEVIATION 0.9 • n=7 Participants	37.5 months STANDARD_DEVIATION 0.9 • n=5 Participants
Sex: Female, Male Female	173 Participants n=5 Participants	155 Participants n=7 Participants	328 Participants n=5 Participants
Sex: Female, Male Male	170 Participants n=5 Participants	168 Participants n=7 Participants	338 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	71 Participants n=5 Participants	65 Participants n=7 Participants	136 Participants n=5 Participants
Race/Ethnicity, Customized Asian	175 Participants n=5 Participants	159 Participants n=7 Participants	334 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	97 Participants n=5 Participants	99 Participants n=7 Participants	196 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	71 Participants n=5 Participants	65 Participants n=7 Participants	136 Participants n=5 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	272 Participants n=5 Participants	258 Participants n=7 Participants	530 Participants n=5 Participants
Maternal education No formal schooling	52 Participants n=5 Participants	44 Participants n=7 Participants	96 Participants n=5 Participants
Maternal education Years of schooling: 13 years or more	34 Participants n=5 Participants	41 Participants n=7 Participants	75 Participants n=5 Participants
Maternal education Years of schooling: 7-12	196 Participants n=5 Participants	177 Participants n=7 Participants	373 Participants n=5 Participants
Maternal education Years of schooling: Less than 7	61 Participants n=5 Participants	61 Participants n=7 Participants	122 Participants n=5 Participants

PRIMARY outcome

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

Population: The analysis population includes all randomized infants with available data for the primary outcome.

Mean of the Bayley-III Cognitive Composite Score (standardized mean 100, SD 15, range 55-155) (lower scores indicating greater impairment)

Outcome measures

Measure	Aspirin n=329 Participants Children of mothers who received 81mg low-dose aspirin daily beginning between 6 weeks 0 days and 13 weeks 6 days, until 37 weeks or delivery.	Placebo n=311 Participants Children of mothers who received placebo daily beginning between 6 weeks 0 days and 13 weeks 6 days, until 37 weeks or delivery.
Bayley Scales of Infant and Toddler Development, 3rd Edition (Bayley-III) Cognitive Composite Score	96 score on a scale Standard Deviation 9.9	96.8 score on a scale Standard Deviation 10.4

SECONDARY outcome

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

Population: The analysis population includes all randomized infants with available data for the primary outcome.

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)

Outcome measures

Measure	Aspirin n=329 Participants Children of mothers who received 81mg low-dose aspirin daily beginning between 6 weeks 0 days and 13 weeks 6 days, until 37 weeks or delivery.	Placebo n=311 Participants Children of mothers who received placebo daily beginning between 6 weeks 0 days and 13 weeks 6 days, until 37 weeks or delivery.
Bayley Scales of Infant and Toddler Development, 3rd Edition (Bayley-III) Cognitive Composite Score Less Than 70 Participants with Score Greater than or Equal to 70	327 Participants	309 Participants
Bayley Scales of Infant and Toddler Development, 3rd Edition (Bayley-III) Cognitive Composite Score Less Than 70 Participants with Score Less than 70	2 Participants	2 Participants

SECONDARY outcome

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

Population: The analysis population includes all randomized infants with available data for the primary outcome.

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)

Outcome measures

Measure	Aspirin n=329 Participants Children of mothers who received 81mg low-dose aspirin daily beginning between 6 weeks 0 days and 13 weeks 6 days, until 37 weeks or delivery.	Placebo n=311 Participants Children of mothers who received placebo daily beginning between 6 weeks 0 days and 13 weeks 6 days, until 37 weeks or delivery.
Bayley Scales of Infant and Toddler Development, 3rd Edition (Bayley-III) Cognitive Composite Score Less Than 1 Standard Deviation (SD) Below the Mean Participants with Scores Greater than or Equal to 1 Standard Deviation (SD) Below the Mean	297 Participants	285 Participants
Bayley Scales of Infant and Toddler Development, 3rd Edition (Bayley-III) Cognitive Composite Score Less Than 1 Standard Deviation (SD) Below the Mean Participants with Scores Less than 1 Standard Deviation (SD) Below the Mean	32 Participants	26 Participants

SECONDARY outcome

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

Population: The analysis population includes all randomized infants with available data for the primary outcome.

Mean of the Bayley-III Language Composite Score (standardized mean 100, SD 15, range 45-155) (lower scores indicating greater impairment)

Outcome measures

Measure	Aspirin n=328 Participants Children of mothers who received 81mg low-dose aspirin daily beginning between 6 weeks 0 days and 13 weeks 6 days, until 37 weeks or delivery.	Placebo n=306 Participants Children of mothers who received placebo daily beginning between 6 weeks 0 days and 13 weeks 6 days, until 37 weeks or delivery.
Bayley Scales of Infant and Toddler Development, 3rd Edition (Bayley-III) Language Composite Score	101.2 score on a scale Standard Deviation 13.2	100.4 score on a scale Standard Deviation 13.6

SECONDARY outcome

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

Population: The analysis population includes all randomized infants with available data for the primary outcome.

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)

Outcome measures

Measure	Aspirin n=328 Participants Children of mothers who received 81mg low-dose aspirin daily beginning between 6 weeks 0 days and 13 weeks 6 days, until 37 weeks or delivery.	Placebo n=306 Participants Children of mothers who received placebo daily beginning between 6 weeks 0 days and 13 weeks 6 days, until 37 weeks or delivery.
Bayley Scales of Infant and Toddler Development, 3rd Edition (Bayley-III) Language Composite Score Less Than 70 Participants with Score Greater than or Equal to 70	327 Participants	302 Participants
Bayley Scales of Infant and Toddler Development, 3rd Edition (Bayley-III) Language Composite Score Less Than 70 Participants with Score Less than 70	1 Participants	4 Participants

SECONDARY outcome

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

Population: The analysis population includes all randomized infants with available data for the primary outcome.

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)

Outcome measures

Measure	Aspirin n=328 Participants Children of mothers who received 81mg low-dose aspirin daily beginning between 6 weeks 0 days and 13 weeks 6 days, until 37 weeks or delivery.	Placebo n=306 Participants Children of mothers who received placebo daily beginning between 6 weeks 0 days and 13 weeks 6 days, until 37 weeks or delivery.
Bayley Scales of Infant and Toddler Development, 3rd Edition (Bayley-III) Language Composite Score Less Than 1 Standard Deviation (SD) Below the Mean Participants with Scores Greater than or Equal to 1 Standard Deviation (SD) Below the Mean	290 Participants	273 Participants
Bayley Scales of Infant and Toddler Development, 3rd Edition (Bayley-III) Language Composite Score Less Than 1 Standard Deviation (SD) Below the Mean Participants with Scores Less than 1 Standard Deviation (SD) Below the Mean	38 Participants	33 Participants

SECONDARY outcome

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

Population: The analysis population includes all randomized infants with available data for the primary outcome.

Mean of the Bayley-III Motor Composite Score (standardized mean 100, SD 15, range 45-155) (lower scores indicating greater impairment)

Outcome measures

Measure	Aspirin n=326 Participants Children of mothers who received 81mg low-dose aspirin daily beginning between 6 weeks 0 days and 13 weeks 6 days, until 37 weeks or delivery.	Placebo n=308 Participants Children of mothers who received placebo daily beginning between 6 weeks 0 days and 13 weeks 6 days, until 37 weeks or delivery.
Bayley Scales of Infant and Toddler Development, 3rd Edition (Bayley-III) Motor Composite Score	99.4 score on a scale Standard Deviation 13.2	100.1 score on a scale Standard Deviation 13.9

SECONDARY outcome

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

Population: The analysis population includes all randomized infants with available data for the primary outcome.

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)

Outcome measures

Measure	Aspirin n=326 Participants Children of mothers who received 81mg low-dose aspirin daily beginning between 6 weeks 0 days and 13 weeks 6 days, until 37 weeks or delivery.	Placebo n=308 Participants Children of mothers who received placebo daily beginning between 6 weeks 0 days and 13 weeks 6 days, until 37 weeks or delivery.
Bayley Scales of Infant and Toddler Development, 3rd Edition (Bayley-III) Motor Composite Score Less Than 70 Participants with Score Greater than or Equal to 70	323 Participants	305 Participants
Bayley Scales of Infant and Toddler Development, 3rd Edition (Bayley-III) Motor Composite Score Less Than 70 Participants with Score Less than 70	3 Participants	3 Participants

SECONDARY outcome

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

Population: The analysis population includes all randomized infants with available data for the primary outcome.

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)

Outcome measures

Measure	Aspirin n=326 Participants Children of mothers who received 81mg low-dose aspirin daily beginning between 6 weeks 0 days and 13 weeks 6 days, until 37 weeks or delivery.	Placebo n=308 Participants Children of mothers who received placebo daily beginning between 6 weeks 0 days and 13 weeks 6 days, until 37 weeks or delivery.
Bayley Scales of Infant and Toddler Development, 3rd Edition (Bayley-III) Motor Composite Score Less Than 1 Standard Deviation (SD) Below the Mean Participants with Scores Greater than or Equal to 1 Standard Deviation (SD) Below the Mean	281 Participants	264 Participants
Bayley Scales of Infant and Toddler Development, 3rd Edition (Bayley-III) Motor Composite Score Less Than 1 Standard Deviation (SD) Below the Mean Participants with Scores Less than 1 Standard Deviation (SD) Below the Mean	45 Participants	44 Participants

SECONDARY outcome

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

Population: The analysis population includes all randomized infants with available data for the primary outcome.

Mean of the ASQ Communication Total Score (range 0-60) (lower scores indicating greater impairment)

Outcome measures

Measure	Aspirin n=330 Participants Children of mothers who received 81mg low-dose aspirin daily beginning between 6 weeks 0 days and 13 weeks 6 days, until 37 weeks or delivery.	Placebo n=314 Participants Children of mothers who received placebo daily beginning between 6 weeks 0 days and 13 weeks 6 days, until 37 weeks or delivery.
Ages and Stages Questionnaire, 3rd Edition (ASQ-3) Communication Total Score	52 score on a scale Standard Deviation 8.9	50.7 score on a scale Standard Deviation 10.2

SECONDARY outcome

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

Population: The analysis population includes all randomized infants with available data for the primary outcome.

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)

Outcome measures

Measure	Aspirin n=330 Participants Children of mothers who received 81mg low-dose aspirin daily beginning between 6 weeks 0 days and 13 weeks 6 days, until 37 weeks or delivery.	Placebo n=314 Participants Children of mothers who received placebo daily beginning between 6 weeks 0 days and 13 weeks 6 days, until 37 weeks or delivery.
Ages and Stages Questionnaire, 3rd Edition (ASQ-3) Communication Total Score Less Than 1 Standard Deviation (SD) Below the Mean Participants with Scores Greater than or Equal to 1 Standard Deviation (SD) Below the Mean	277 Participants	256 Participants
Ages and Stages Questionnaire, 3rd Edition (ASQ-3) Communication Total Score Less Than 1 Standard Deviation (SD) Below the Mean Participants with Scores Less than 1 Standard Deviation (SD) Below the Mean	53 Participants	58 Participants

SECONDARY outcome

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

Population: The analysis population includes all randomized infants with available data for the primary outcome.

Mean of the ASQ Gross Motor Total Score (range 0-60) (lower scores indicating greater impairment)

Outcome measures

Measure	Aspirin n=330 Participants Children of mothers who received 81mg low-dose aspirin daily beginning between 6 weeks 0 days and 13 weeks 6 days, until 37 weeks or delivery.	Placebo n=314 Participants Children of mothers who received placebo daily beginning between 6 weeks 0 days and 13 weeks 6 days, until 37 weeks or delivery.
Ages and Stages Questionnaire, 3rd Edition (ASQ-3) Gross Motor Total Score	47.8 score on a scale Standard Deviation 12	48.3 score on a scale Standard Deviation 12.6

SECONDARY outcome

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

Population: The analysis population includes all randomized infants with available data for the primary outcome.

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)

Outcome measures

Measure	Aspirin n=330 Participants Children of mothers who received 81mg low-dose aspirin daily beginning between 6 weeks 0 days and 13 weeks 6 days, until 37 weeks or delivery.	Placebo n=314 Participants Children of mothers who received placebo daily beginning between 6 weeks 0 days and 13 weeks 6 days, until 37 weeks or delivery.
Ages and Stages Questionnaire, 3rd Edition (ASQ-3) Gross Motor Total Score Less Than 1 Standard Deviation (SD) Below the Mean Participants with Scores Greater than or Equal to 1 Standard Deviation (SD) Below the Mean	270 Participants	253 Participants
Ages and Stages Questionnaire, 3rd Edition (ASQ-3) Gross Motor Total Score Less Than 1 Standard Deviation (SD) Below the Mean Participants with Scores Less than 1 Standard Deviation (SD) Below the Mean	60 Participants	61 Participants

SECONDARY outcome

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

Population: The analysis population includes all randomized infants with available data for the primary outcome.

Mean of the ASQ Fine Motor Total Score (range 0-60) (lower scores indicating greater impairment)

Outcome measures

Measure	Aspirin n=330 Participants Children of mothers who received 81mg low-dose aspirin daily beginning between 6 weeks 0 days and 13 weeks 6 days, until 37 weeks or delivery.	Placebo n=314 Participants Children of mothers who received placebo daily beginning between 6 weeks 0 days and 13 weeks 6 days, until 37 weeks or delivery.
Ages and Stages Questionnaire, 3rd Edition (ASQ-3) Fine Motor Total Score	39.6 score on a scale Standard Deviation 16.6	38.3 score on a scale Standard Deviation 16

SECONDARY outcome

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

Population: The analysis population includes all randomized infants with available data for the primary outcome.

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)

Outcome measures

Measure	Aspirin n=330 Participants Children of mothers who received 81mg low-dose aspirin daily beginning between 6 weeks 0 days and 13 weeks 6 days, until 37 weeks or delivery.	Placebo n=314 Participants Children of mothers who received placebo daily beginning between 6 weeks 0 days and 13 weeks 6 days, until 37 weeks or delivery.
Ages and Stages Questionnaire, 3rd Edition (ASQ-3) Fine Motor Total Score Less Than 1 Standard Deviation (SD) Below the Mean Participants with Scores Greater than or Equal to 1 Standard Deviation (SD) Below the Mean	255 Participants	246 Participants
Ages and Stages Questionnaire, 3rd Edition (ASQ-3) Fine Motor Total Score Less Than 1 Standard Deviation (SD) Below the Mean Participants with Scores Less than 1 Standard Deviation (SD) Below the Mean	75 Participants	68 Participants

SECONDARY outcome

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

Population: The analysis population includes all randomized infants with available data for the primary outcome.

Mean of the ASQ Problem Solving Total Score (range 0-60) (lower scores indicating greater impairment)

Outcome measures

Measure	Aspirin n=330 Participants Children of mothers who received 81mg low-dose aspirin daily beginning between 6 weeks 0 days and 13 weeks 6 days, until 37 weeks or delivery.	Placebo n=314 Participants Children of mothers who received placebo daily beginning between 6 weeks 0 days and 13 weeks 6 days, until 37 weeks or delivery.
Ages and Stages Questionnaire, 3rd Edition (ASQ-3) Problem Solving Total Score	40.2 score on a scale Standard Deviation 13.7	40.2 score on a scale Standard Deviation 13.7

SECONDARY outcome

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

Population: The analysis population includes all randomized infants with available data for the primary outcome.

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)

Outcome measures

Measure	Aspirin n=330 Participants Children of mothers who received 81mg low-dose aspirin daily beginning between 6 weeks 0 days and 13 weeks 6 days, until 37 weeks or delivery.	Placebo n=314 Participants Children of mothers who received placebo daily beginning between 6 weeks 0 days and 13 weeks 6 days, until 37 weeks or delivery.
Ages and Stages Questionnaire, 3rd Edition (ASQ-3) Problem Solving Total Score Less Than 1 Standard Deviation (SD) Below the Mean Participants with Scores Greater than or Equal to 1 Standard Deviation (SD) Below the Mean	265 Participants	256 Participants
Ages and Stages Questionnaire, 3rd Edition (ASQ-3) Problem Solving Total Score Less Than 1 Standard Deviation (SD) Below the Mean Participants with Scores Less than 1 Standard Deviation (SD) Below the Mean	65 Participants	58 Participants

SECONDARY outcome

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

Population: The analysis population includes all randomized infants with available data for the primary outcome.

Mean of the ASQ Personal Social Total Score (range 0-60) (lower scores indicating greater impairment)

Outcome measures

Measure	Aspirin n=330 Participants Children of mothers who received 81mg low-dose aspirin daily beginning between 6 weeks 0 days and 13 weeks 6 days, until 37 weeks or delivery.	Placebo n=314 Participants Children of mothers who received placebo daily beginning between 6 weeks 0 days and 13 weeks 6 days, until 37 weeks or delivery.
Ages and Stages Questionnaire, 3rd Edition (ASQ-3) Personal Social Total Score	45.5 score on a scale Standard Deviation 9.8	45.3 score on a scale Standard Deviation 10

SECONDARY outcome

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

Population: The analysis population includes all randomized infants with available data for the primary outcome.

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)

Outcome measures

Measure	Aspirin n=330 Participants Children of mothers who received 81mg low-dose aspirin daily beginning between 6 weeks 0 days and 13 weeks 6 days, until 37 weeks or delivery.	Placebo n=314 Participants Children of mothers who received placebo daily beginning between 6 weeks 0 days and 13 weeks 6 days, until 37 weeks or delivery.
Ages and Stages Questionnaire, 3rd Edition (ASQ-3) Personal Social Total Score Less Than 1 Standard Deviation (SD) Below the Mean Participants with Scores Greater than or Equal to 1 Standard Deviation (SD) Below the Mean	273 Participants	252 Participants
Ages and Stages Questionnaire, 3rd Edition (ASQ-3) Personal Social Total Score Less Than 1 Standard Deviation (SD) Below the Mean Participants with Scores Less than 1 Standard Deviation (SD) Below the Mean	57 Participants	62 Participants

Adverse Events

Aspirin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Elizabeth McClure

RTI International

Phone: 919-316-3773

Email: mcclure@rti.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place