Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04888377 |
| Other study ID # |
GN ASPIRIN Follow Up |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2021 |
| Est. completion date |
June 15, 2022 |
Study information
| Verified date |
June 2022 |
| Source |
NICHD Global Network for Women's and Children's Health |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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).
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 (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.
