← Back to Search

Nonsteroidal Anti-inflammatory Drug

Antenatal exposure to low dose aspirin for Neurodevelopmental Disorder

N/A
Waitlist Available
Led By Elizabeth McClure, PhD
Research Sponsored by NICHD Global Network for Women's and Children's Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months

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).

Eligible Conditions
  • Neurodevelopmental Disorder

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
BSID-III Examination
Secondary study objectives
ASQ-3
Other study objectives
Family Care Indicators
Infant Feeding Index

Trial Design

2Treatment groups
Experimental Treatment
Group I: Antenatal exposure to low dose aspirinExperimental Treatment1 Intervention
Mothers in the Global Networks ASPIRIN trial were given 81 mg of Aspirin throughout their pregnancy with the follow-up studies participant.
Group II: Antenatal exposure to PlaceboExperimental Treatment1 Intervention
Mothers in the Global Networks ASPIRIN trial were given placebo throughout their pregnancy with the follow-up studies participant.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aspirin
2014
Completed Phase 4
~55580
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

NICHD Global Network for Women's and Children's HealthLead Sponsor
30 Previous Clinical Trials
1,613,493 Total Patients Enrolled
Thomas Jefferson UniversityOTHER
461 Previous Clinical Trials
149,991 Total Patients Enrolled
RTI InternationalOTHER
196 Previous Clinical Trials
819,133 Total Patients Enrolled
~163 spots leftby Oct 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top