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CompletedNCT04888377Updated Oct 21, 2024Results posted

ASPIRIN: Neurodevelopmental Follow-up Trial

An observational study in Neurodevelopmental Abnormality, sponsored by NICHD Global Network for Women's and Children's Health. Completed at 14 sites in 6 countries. Open to participants aged 33 Months to 39 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-21.

Sponsored by NICHD Global Network for Women's and Children's Health · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
666
Ages
33 Months to 39 Months
Sex
All
01

Study 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).

Read the detailed description

An estimated 250 million children under the age of 511 worldwide are at risk for not achieving their developmental potential; 52.9 million children under five years of age in low- and middle-income country (LMIC) settings have neurodevelopmental delays. Compounding the issue is preterm birth (more common in LMICs) which has consistently been identified as a cause of neurodevelopmental delay. A recent review reported that out of the estimated 13 million preterm infants who survive beyond the first month, 0.9 million will suffer long term neurodevelopmental impairment, with 345,000 moderately or severely affected. This burden places a significant strain on the families, healthcare systems and societies that provide care for these children. Data from other Global Network participating sites (Guatemala, Democratic Republic of Congo, Zambia and Pakistan) also found strikingly high rates of stunting ranging from 44% to 66%, among infants and toddlers. Poverty additionally contributes to the attainment of optimal neurodevelopment. As such, any study of neurodevelopment should at least document these potential confounders.

Aspirin has been shown to predominantly affect both the COX-1 pathway which is involved in thrombosis and the COX-2 pathway, which affects inflammation through the production of Aspirin Triggered Lipoxins. More specifically, aspirin has been shown to inhibit the production of IL-6, IL-1B, CRP and TNF-α all of which have been shown to negatively affect child neurodevelopment and be involved in preeclampsia and preterm birth.

This will be a prospective masked matched cohort study of children between 33 and 39 months (mean 36 months) of age whose mothers were randomized in the ASPIRIN trial *NCT02409680* (1:1 Aspirin-Placebo), who will be evaluated using the BSID-III. Additionally, the Family Resources and Context questionnaire will be performed to adjust for the local context and the ASQ-3 will be administered as a secondary screen. Recognizing the significant role that preterm birth plays in neurodevelopment, the investigators will include 100 (50 in each group) children who were delivered before 37 weeks.

02

Conditions studied

  • Neurodevelopmental Abnormality

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Keywords

  • Pre-eclampsia
  • Low Dose Aspirin
  • ASPIRIN Trail
  • NICHD Global Network
  • Global Network
  • ASPRIN Follow Up
  • BSID-III
  • Family Resources and Context
  • ASQ-36
  • Neurodevelopmental delays
  • hypertensive disorders of pregnancy (HDP)
  • Pre-term birth
  • LDA
03

In context

Pre-Eclampsia

903 studies on the registry are indexed under Pre-Eclampsia; 240 are open to participants now.

This study's enrollment of 666 is above the median of 160 across 389 observational studies indexed under Pre-Eclampsia.

Browse Pre-Eclampsia studies →

Lead sponsor

NICHD Global Network for Women's and Children's Health is the lead sponsor of 33 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
33 Months to 39 Months
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

The study population will consist of approximately 620 children, between 33 and 39 months of age, whose mothers were included in the ASPIRIN trial.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • The child does not meet the inclusion criteria.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
666 participants (actual)
Patient registry
No

Groups and cohorts

  • Antenatal exposure to low dose aspirin

    Mothers in the Global Networks ASPIRIN trial were given 81 mg of Aspirin throughout their pregnancy with the follow-up studies participant.

    Drug: Aspirin

  • Antenatal exposure to Placebo

    Mothers in the Global Networks ASPIRIN trial were given placebo throughout their pregnancy with the follow-up studies participant.

    Drug: Placebo

Interventions

  • DrugAspirin

    Participant's mothers were administered 81mg of Aspirin throughout their pregnancy with the participant.

  • DrugPlacebo

    Participant's mothers were administered placebo throughout their pregnancy with the participant.

06

What researchers measure

Primary outcomes

  1. 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)

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

Secondary outcomes

  1. 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)

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

  2. 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)

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

  3. 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)

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

  4. 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)

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

  5. 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)

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

  6. 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)

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

  7. 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)

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

  8. 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)

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

  9. 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)

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

  10. 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)

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

  11. 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)

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

  12. 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)

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

  13. 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)

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

  14. 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)

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

  15. 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)

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

  16. 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)

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

  17. 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)

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

  18. 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)

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

07

Results

Posted Oct 21, 2024

Participant flow

Participant flow — Overall Study
MilestoneAspirinPlacebo
Started343323
Completed bsid-iii assessment330312
Completed329311
Not completed1412
Withdrew: Incomplete follow-up or no study data13
Withdrew: Physician decision66
Withdrew: Withdrawal by subject73

Outcome measures

PrimaryBayley 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)

Time frame:
At a single visit occurring between 33-39 months corrected age
Reported as:
Mean · score on a scale
Bayley Scales of Infant and Toddler Development, 3rd Edition (Bayley-III) Cognitive Composite Score
score on a scaleAspirinPlacebo
Bayley Scales of Infant and Toddler Development, 3rd Edition (Bayley-III) Cognitive Composite Score96 ± 9.996.8 ± 10.4
Statistical analysis
  • Aspirin vs Placebo · ANCOVA · p = 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 · 95% CI -2.2 to 0.6Mean difference is Aspirin-Placebo.
SecondaryBayley 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)

Time frame:
At a single visit occurring between 33-39 months corrected age
Reported as:
Count of participants · Participants
Bayley Scales of Infant and Toddler Development, 3rd Edition (Bayley-III) Cognitive Composite Score Less Than 70
ParticipantsAspirinPlacebo
Participants with Score Greater than or Equal to 70327309
Participants with Score Less than 7022
SecondaryBayley 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)

Time frame:
At a single visit occurring between 33-39 months corrected age
Reported as:
Count of participants · Participants
Bayley Scales of Infant and Toddler Development, 3rd Edition (Bayley-III) Cognitive Composite Score Less Than 1 Standard Deviation (SD) Below the Mean
ParticipantsAspirinPlacebo
Participants with Scores Greater than or Equal to 1 Standard Deviation (SD) Below the Mean297285
Participants with Scores Less than 1 Standard Deviation (SD) Below the Mean3226
SecondaryBayley 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)

Time frame:
At a single visit occurring between 33-39 months corrected age
Reported as:
Mean · score on a scale
Bayley Scales of Infant and Toddler Development, 3rd Edition (Bayley-III) Language Composite Score
score on a scaleAspirinPlacebo
Bayley Scales of Infant and Toddler Development, 3rd Edition (Bayley-III) Language Composite Score101.2 ± 13.2100.4 ± 13.6
SecondaryBayley 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)

Time frame:
At a single visit occurring between 33-39 months corrected age
Reported as:
Count of participants · Participants
Bayley Scales of Infant and Toddler Development, 3rd Edition (Bayley-III) Language Composite Score Less Than 70
ParticipantsAspirinPlacebo
Participants with Score Greater than or Equal to 70327302
Participants with Score Less than 7014
SecondaryBayley 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)

Time frame:
At a single visit occurring between 33-39 months corrected age
Reported as:
Count of participants · Participants
Bayley Scales of Infant and Toddler Development, 3rd Edition (Bayley-III) Language Composite Score Less Than 1 Standard Deviation (SD) Below the Mean
ParticipantsAspirinPlacebo
Participants with Scores Greater than or Equal to 1 Standard Deviation (SD) Below the Mean290273
Participants with Scores Less than 1 Standard Deviation (SD) Below the Mean3833
SecondaryBayley 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)

Time frame:
At a single visit occurring between 33-39 months corrected age
Reported as:
Mean · score on a scale
Bayley Scales of Infant and Toddler Development, 3rd Edition (Bayley-III) Motor Composite Score
score on a scaleAspirinPlacebo
Bayley Scales of Infant and Toddler Development, 3rd Edition (Bayley-III) Motor Composite Score99.4 ± 13.2100.1 ± 13.9
SecondaryBayley 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)

Time frame:
At a single visit occurring between 33-39 months corrected age
Reported as:
Count of participants · Participants
Bayley Scales of Infant and Toddler Development, 3rd Edition (Bayley-III) Motor Composite Score Less Than 70
ParticipantsAspirinPlacebo
Participants with Score Greater than or Equal to 70323305
Participants with Score Less than 7033
SecondaryBayley 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)

Time frame:
At a single visit occurring between 33-39 months corrected age
Reported as:
Count of participants · Participants
Bayley Scales of Infant and Toddler Development, 3rd Edition (Bayley-III) Motor Composite Score Less Than 1 Standard Deviation (SD) Below the Mean
ParticipantsAspirinPlacebo
Participants with Scores Greater than or Equal to 1 Standard Deviation (SD) Below the Mean281264
Participants with Scores Less than 1 Standard Deviation (SD) Below the Mean4544
SecondaryAges 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)

Time frame:
At a single visit occurring between 33-39 months corrected age
Reported as:
Mean · score on a scale
Ages and Stages Questionnaire, 3rd Edition (ASQ-3) Communication Total Score
score on a scaleAspirinPlacebo
Ages and Stages Questionnaire, 3rd Edition (ASQ-3) Communication Total Score52 ± 8.950.7 ± 10.2
SecondaryAges 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)

Time frame:
At a single visit occurring between 33-39 months corrected age
Reported as:
Count of participants · Participants
Ages and Stages Questionnaire, 3rd Edition (ASQ-3) Communication Total Score Less Than 1 Standard Deviation (SD) Below the Mean
ParticipantsAspirinPlacebo
Participants with Scores Greater than or Equal to 1 Standard Deviation (SD) Below the Mean277256
Participants with Scores Less than 1 Standard Deviation (SD) Below the Mean5358
SecondaryAges 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)

Time frame:
At a single visit occurring between 33-39 months corrected age
Reported as:
Mean · score on a scale
Ages and Stages Questionnaire, 3rd Edition (ASQ-3) Gross Motor Total Score
score on a scaleAspirinPlacebo
Ages and Stages Questionnaire, 3rd Edition (ASQ-3) Gross Motor Total Score47.8 ± 1248.3 ± 12.6
SecondaryAges 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)

Time frame:
At a single visit occurring between 33-39 months corrected age
Reported as:
Count of participants · Participants
Ages and Stages Questionnaire, 3rd Edition (ASQ-3) Gross Motor Total Score Less Than 1 Standard Deviation (SD) Below the Mean
ParticipantsAspirinPlacebo
Participants with Scores Greater than or Equal to 1 Standard Deviation (SD) Below the Mean270253
Participants with Scores Less than 1 Standard Deviation (SD) Below the Mean6061
SecondaryAges 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)

Time frame:
At a single visit occurring between 33-39 months corrected age
Reported as:
Mean · score on a scale
Ages and Stages Questionnaire, 3rd Edition (ASQ-3) Fine Motor Total Score
score on a scaleAspirinPlacebo
Ages and Stages Questionnaire, 3rd Edition (ASQ-3) Fine Motor Total Score39.6 ± 16.638.3 ± 16
SecondaryAges 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)

Time frame:
At a single visit occurring between 33-39 months corrected age
Reported as:
Count of participants · Participants
Ages and Stages Questionnaire, 3rd Edition (ASQ-3) Fine Motor Total Score Less Than 1 Standard Deviation (SD) Below the Mean
ParticipantsAspirinPlacebo
Participants with Scores Greater than or Equal to 1 Standard Deviation (SD) Below the Mean255246
Participants with Scores Less than 1 Standard Deviation (SD) Below the Mean7568
SecondaryAges 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)

Time frame:
At a single visit occurring between 33-39 months corrected age
Reported as:
Mean · score on a scale
Ages and Stages Questionnaire, 3rd Edition (ASQ-3) Problem Solving Total Score
score on a scaleAspirinPlacebo
Ages and Stages Questionnaire, 3rd Edition (ASQ-3) Problem Solving Total Score40.2 ± 13.740.2 ± 13.7
SecondaryAges 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)

Time frame:
At a single visit occurring between 33-39 months corrected age
Reported as:
Count of participants · Participants
Ages and Stages Questionnaire, 3rd Edition (ASQ-3) Problem Solving Total Score Less Than 1 Standard Deviation (SD) Below the Mean
ParticipantsAspirinPlacebo
Participants with Scores Greater than or Equal to 1 Standard Deviation (SD) Below the Mean265256
Participants with Scores Less than 1 Standard Deviation (SD) Below the Mean6558
SecondaryAges 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)

Time frame:
At a single visit occurring between 33-39 months corrected age
Reported as:
Mean · score on a scale
Ages and Stages Questionnaire, 3rd Edition (ASQ-3) Personal Social Total Score
score on a scaleAspirinPlacebo
Ages and Stages Questionnaire, 3rd Edition (ASQ-3) Personal Social Total Score45.5 ± 9.845.3 ± 10
SecondaryAges 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)

Time frame:
At a single visit occurring between 33-39 months corrected age
Reported as:
Count of participants · Participants
Ages and Stages Questionnaire, 3rd Edition (ASQ-3) Personal Social Total Score Less Than 1 Standard Deviation (SD) Below the Mean
ParticipantsAspirinPlacebo
Participants with Scores Greater than or Equal to 1 Standard Deviation (SD) Below the Mean273252
Participants with Scores Less than 1 Standard Deviation (SD) Below the Mean5762

Adverse events

Collected over At a single visit occurring at 33-39 months corrected age. Non-serious events are listed at a 0.05% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Aspirin0/329 (0%)0/329 (0%)0/329 (0%)
Placebo0/311 (0%)0/311 (0%)0/311 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(months)AspirinPlaceboTotal
Mean37.5 ± 137.5 ± 0.937.5 ± 0.9
Sex: Female, Male
Sex: Female, Male(Participants)AspirinPlaceboTotal
Female173155328
Male170168338
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)AspirinPlaceboTotal
American Indian or Alaska Native7165136
Asian175159334
Black or African American9799196
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)AspirinPlaceboTotal
Hispanic or Latino7165136
Not Hispanic or Latino272258530
Maternal education
Maternal education(Participants)AspirinPlaceboTotal
No formal schooling524496
Years of schooling: 13 years or more344175
Years of schooling: 7-12196177373
Years of schooling: Less than 76161122
08

Study locations

14 sites
  • University of Alabama, Birmingham
    Birmingham, Alabama 35233, United States
  • University of Colorado Health Sciences Center
    Denver, Colorado 80208, United States
  • Christiana Care
    Newark, Delaware 19718, United States
  • Boston University
    Boston, Massachusetts 02115, United States
  • Columbia University
    New York, New York 10032, United States
  • University of North Carolina School of Medicine
    Chapel Hill, North Carolina 27599, United States
  • RTI International
    Research Triangle Park, North Carolina 27709, United States
  • Thomas Jefferson University
    Philadelphia, Pennsylvania 19107, 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
09

References and documents

Publications

  • Hoffman MK, Goudar S, Dhaded S, Figueroa L, Mazariegos M, Krebs NF, Westcott J, Tikmani SS, Karim F, Saleem S, Goldenberg RL, Lokangaka A, Tshefu A, Bauserman M, Patel A, Das P, Hibberd P, Chomba E, Mwenchanya M, Carlo WA, Trotta M, Williams A, Moore J, Nolen T, Goco N, McClure EM, Lobo MA, Cunha AB, Derman RJ. Neurodevelopment of Children Whose Mothers Were Randomized to Low-Dose Aspirin During Pregnancy. Obstet Gynecol. 2024 Apr 1;143(4):554-561. doi: 10.1097/AOG.0000000000005514. Epub 2024 Jan 23. PubMed 38262066 ↗

Study documents

  • Protocol and statistical analysis plan · Jul 30, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — The plan is to release primary results from the study.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 21, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04888377
Lead sponsor
NICHD Global Network for Women's and Children's Health
Collaborators
Thomas Jefferson University, RTI International, Thrasher Research Fund
Responsible party
Sponsor
First posted
May 17, 2021
Start date
Sep 1, 2021
Primary completion
Jun 15, 2022
Completion
Jun 15, 2022
Results posted
Oct 21, 2024
Last update
Oct 21, 2024

Study contacts

Elizabeth McClure, PhD
principal investigator · RTI International

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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