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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: Completed study of Neurodevelopmental Abnormality, sponsored by NICHD Global Network for Women's and Children's Health.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Mean of the Bayley-III Cognitive Composite Score (standardized mean 100, SD 15, range 55-155) (lower scores indicating greater impairment)
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 |
What the finished NCT04888377 record still lists
NCT04888377 is an observational study that tracks outcomes without assigning an intervention. The registered 666 participants enrollment target is mid-sized for trials with a published cap.
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 lists 14 locations in 8 states (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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