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ASPIRIN: Neurodevelopmental Follow-up Trial

NCT04888377 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 666

Last updated 2024-10-21

Study results available
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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).

Conditions

  • Neurodevelopmental Abnormality

Interventions

DRUG

Aspirin

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

DRUG

Placebo

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

Sponsors & Collaborators

  • Thomas Jefferson University

    collaborator OTHER

  • RTI International

    collaborator OTHER

  • Thrasher Research Fund

    collaborator OTHER

  • NICHD Global Network for Women's and Children's Health

    lead NETWORK

Principal Investigators

  • Elizabeth McClure, PhD · RTI International

Eligibility

Min Age
33 Months
Max Age
39 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-09-01
Primary Completion
2022-06-15
Completion
2022-06-15

Countries

  • United States
  • Democratic Republic of the Congo
  • Guatemala
  • India
  • Pakistan
  • Zambia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04888377 on ClinicalTrials.gov