| Primary | 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) | The analysis population includes all randomized infants with available data for the primary outcome. | Posted | | Mean | Standard Deviation | score on a scale | | At a single visit occurring between 33-39 months corrected age | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Placebo | Children of mothers who received placebo daily beginning between 6 weeks 0 days and 13 weeks 6 days, until 37 weeks or delivery. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00096± 9.9
- OG00196.8± 10.4
|
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| Assuming a non-inferiority margin of 4 points in the BSID-III cognitive score as clinically significant, and a true effect of LDA of not more than a 1 point decrease, a total sample size of 620 was determined to provide 80% power for a one-sided test for non-inferiority with a type I error of 5%. To test this secondary hypothesis, the sample size also provided over 90% power, at a two-sided type I error of 5%, to detect a difference of 4 points between LDA and placebo based on a two-sided test. | ANCOVA | | 0.25 | For each outcome, the adjusted mean difference between treatment groups and the associated 95% confidence interval based on an ANCOVA model is presented. | Mean Difference (Final Values) | -0.8 | | | 2-Sided | 95 | -2.2 | 0.6 | | | Mean difference is Aspirin-Placebo. |
|
| Secondary | 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) | The analysis population includes all randomized infants with available data for the primary outcome. | Posted | | Count of Participants | | Participants | | At a single visit occurring between 33-39 months corrected age | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Placebo | Children of mothers who received placebo daily beginning between 6 weeks 0 days and 13 weeks 6 days, until 37 weeks or delivery. |
| |
| Secondary | 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) | The analysis population includes all randomized infants with available data for the primary outcome. | Posted | | Count of Participants | | Participants | | At a single visit occurring between 33-39 months corrected age | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Placebo | Children of mothers who received placebo daily beginning between 6 weeks 0 days and 13 weeks 6 days, until 37 weeks or delivery. |
| |
| Secondary | 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) | The analysis population includes all randomized infants with available data for the primary outcome. | Posted | | Mean | Standard Deviation | score on a scale | | At a single visit occurring between 33-39 months corrected age | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Placebo | Children of mothers who received placebo daily beginning between 6 weeks 0 days and 13 weeks 6 days, until 37 weeks or delivery. |
| |
| Secondary | 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) | The analysis population includes all randomized infants with available data for the primary outcome. | Posted | | Count of Participants | | Participants | | At a single visit occurring between 33-39 months corrected age | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Placebo | Children of mothers who received placebo daily beginning between 6 weeks 0 days and 13 weeks 6 days, until 37 weeks or delivery. |
| |
| Secondary | 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) | The analysis population includes all randomized infants with available data for the primary outcome. | Posted | | Count of Participants | | Participants | | At a single visit occurring between 33-39 months corrected age | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Placebo | Children of mothers who received placebo daily beginning between 6 weeks 0 days and 13 weeks 6 days, until 37 weeks or delivery. |
| |
| Secondary | 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) | The analysis population includes all randomized infants with available data for the primary outcome. | Posted | | Mean | Standard Deviation | score on a scale | | At a single visit occurring between 33-39 months corrected age | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Placebo | Children of mothers who received placebo daily beginning between 6 weeks 0 days and 13 weeks 6 days, until 37 weeks or delivery. |
| |
| Secondary | 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) | The analysis population includes all randomized infants with available data for the primary outcome. | Posted | | Count of Participants | | Participants | | At a single visit occurring between 33-39 months corrected age | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Placebo | Children of mothers who received placebo daily beginning between 6 weeks 0 days and 13 weeks 6 days, until 37 weeks or delivery. |
| |
| Secondary | 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) | The analysis population includes all randomized infants with available data for the primary outcome. | Posted | | Count of Participants | | Participants | | At a single visit occurring between 33-39 months corrected age | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Placebo | Children of mothers who received placebo daily beginning between 6 weeks 0 days and 13 weeks 6 days, until 37 weeks or delivery. |
| |
| Secondary | 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) | The analysis population includes all randomized infants with available data for the primary outcome. | Posted | | Mean | Standard Deviation | score on a scale | | At a single visit occurring between 33-39 months corrected age | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Placebo | Children of mothers who received placebo daily beginning between 6 weeks 0 days and 13 weeks 6 days, until 37 weeks or delivery. |
| |
| Secondary | 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) | The analysis population includes all randomized infants with available data for the primary outcome. | Posted | | Count of Participants | | Participants | | At a single visit occurring between 33-39 months corrected age | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Placebo | Children of mothers who received placebo daily beginning between 6 weeks 0 days and 13 weeks 6 days, until 37 weeks or delivery. |
| |
| Secondary | 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) | The analysis population includes all randomized infants with available data for the primary outcome. | Posted | | Mean | Standard Deviation | score on a scale | | At a single visit occurring between 33-39 months corrected age | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Placebo | Children of mothers who received placebo daily beginning between 6 weeks 0 days and 13 weeks 6 days, until 37 weeks or delivery. |
| |
| Secondary | 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) | The analysis population includes all randomized infants with available data for the primary outcome. | Posted | | Count of Participants | | Participants | | At a single visit occurring between 33-39 months corrected age | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Placebo | Children of mothers who received placebo daily beginning between 6 weeks 0 days and 13 weeks 6 days, until 37 weeks or delivery. |
| |
| Secondary | 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) | The analysis population includes all randomized infants with available data for the primary outcome. | Posted | | Mean | Standard Deviation | score on a scale | | At a single visit occurring between 33-39 months corrected age | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Placebo | Children of mothers who received placebo daily beginning between 6 weeks 0 days and 13 weeks 6 days, until 37 weeks or delivery. |
| |
| Secondary | 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) | The analysis population includes all randomized infants with available data for the primary outcome. | Posted | | Count of Participants | | Participants | | At a single visit occurring between 33-39 months corrected age | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Placebo | Children of mothers who received placebo daily beginning between 6 weeks 0 days and 13 weeks 6 days, until 37 weeks or delivery. |
| |
| Secondary | 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) | The analysis population includes all randomized infants with available data for the primary outcome. | Posted | | Mean | Standard Deviation | score on a scale | | At a single visit occurring between 33-39 months corrected age | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Placebo | Children of mothers who received placebo daily beginning between 6 weeks 0 days and 13 weeks 6 days, until 37 weeks or delivery. |
| |
| Secondary | 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) | The analysis population includes all randomized infants with available data for the primary outcome. | Posted | | Count of Participants | | Participants | | At a single visit occurring between 33-39 months corrected age | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Placebo | Children of mothers who received placebo daily beginning between 6 weeks 0 days and 13 weeks 6 days, until 37 weeks or delivery. |
| |
| Secondary | 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) | The analysis population includes all randomized infants with available data for the primary outcome. | Posted | | Mean | Standard Deviation | score on a scale | | At a single visit occurring between 33-39 months corrected age | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Placebo | Children of mothers who received placebo daily beginning between 6 weeks 0 days and 13 weeks 6 days, until 37 weeks or delivery. |
| |
| Secondary | 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) | The analysis population includes all randomized infants with available data for the primary outcome. | Posted | | Count of Participants | | Participants | | At a single visit occurring between 33-39 months corrected age | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Placebo | Children of mothers who received placebo daily beginning between 6 weeks 0 days and 13 weeks 6 days, until 37 weeks or delivery. |
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