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NCT04888377 · ClinicalTrials.gov registry record
ASPIRIN: Neurodevelopmental Follow-up Trial
A clinical trial of Neurodevelopmental Abnormality, sponsored by NICHD Global Network for Women's and Children's Health.
- Completed
- Registry status
- 666
- Enrollment target
- 14
- Study locations
NCT04888377 is a study of Neurodevelopmental Abnormality that has completed, run by NICHD Global Network for Women's and Children's Health. The registered enrollment target is 666 participants. The trial reports 14 study locations across 8 states.
The verdict
NCT04888377, a study of Neurodevelopmental Abnormality, has completed, sponsored by NICHD Global Network for Women's and Children's Health.
- COMPLETED
- Registry status
- 666 participants
- Enrollment target
- 14
- Study locations
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).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Aspirin
Study Locations (14)
Other
- Kinshasa School of Public Health - Kinshasa
- INCAP - Guatemala City
- Jawaharlal Nehru Medical College - Belagavi
- Lata Medical Research Foundation - Nagpur
- Aga Khan University - Karachi
- University Teaching Hospital - Lusaka
North Carolina
- University of North Carolina School of Medicine - Chapel Hill
- RTI International - Research Triangle Park
Alabama
- University of Alabama, Birmingham - Birmingham
Colorado
- University of Colorado Health Sciences Center - Denver
Delaware
- Christiana Care - Newark
Massachusetts
- Boston University - Boston
New York
- Columbia University - New York
Pennsylvania
- Thomas Jefferson University - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 666 participants |
| Start Date | 2021-09-01 |
| Est. Completion | 2022-06-15 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04888377
The ClinicalTrials.gov registry entry for NCT04888377 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 666 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NICHD Global Network for Women's and Children's Health, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Neurodevelopmental Abnormality appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04888377 reports 14 study locations spanning 8 distinct geographic areas - top geographies include Other, North Carolina, Alabama.
Frequently Asked Questions
What is clinical trial NCT04888377 about?
NCT04888377 is a clinical study titled "ASPIRIN: Neurodevelopmental Follow-up Trial". 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 de...
What is the current status of trial NCT04888377?
This trial is currently completed. The enrollment target is 666 participants. The study started on 2021-09-01. Estimated completion is 2022-06-15.
What conditions does trial NCT04888377 study?
This clinical trial studies the following conditions: Neurodevelopmental Abnormality.
What interventions are being tested in trial NCT04888377?
The interventions under investigation include: Placebo (DRUG), Aspirin (DRUG).
Who is sponsoring clinical trial NCT04888377?
This trial is sponsored by NICHD Global Network for Women's and Children's Health, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04888377 being conducted?
This trial has 14 study locations across Alabama, Colorado, Delaware, Massachusetts, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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