ASPIRIN: Neurodevelopmental Follow-up Trial
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|ClinicalTrials.gov Identifier: NCT04888377|
Recruitment Status : Completed
First Posted : May 17, 2021
Last Update Posted : June 27, 2022
|Condition or disease||Intervention/treatment|
|Neurodevelopmental Abnormality||Drug: Aspirin Drug: Placebo|
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.
|Study Type :||Observational|
|Actual Enrollment :||666 participants|
|Official Title:||Aspirin Supplementation for Pregnancy Indicated Risk Reduction in Nulliparas (ASPIRIN): Neurodevelopmental Follow-up Trial|
|Actual Study Start Date :||September 1, 2021|
|Actual Primary Completion Date :||June 15, 2022|
|Actual Study Completion Date :||June 15, 2022|
Antenatal exposure to low dose aspirin
Mothers in the Global Networks ASPIRIN trial were given 81 mg of Aspirin throughout their pregnancy with the follow-up studies participant.
Participant's mothers were administered 81mg of Aspirin throughout their pregnancy with the participant.
Antenatal exposure to Placebo
Mothers in the Global Networks ASPIRIN trial were given placebo throughout their pregnancy with the follow-up studies participant.
Participant's mothers were administered placebo throughout their pregnancy with the participant.
- BSID-III Examination [ Time Frame: 36 months ]BSID-III examination at 36 months of life (+/-3months) with margins of 0-4 points. Minimum score of 1 and maximum score of 130. The lower score is a bad outcome and a higher score is good outcome.
- ASQ-3 [ Time Frame: 36 months ]Accepted and Validated screening tool for neurodevelopment at 36 months of life (+/-3months). Minimum score of 0 and maximum score of 60. The lower score is a bad outcome and a higher score is good outcome.
- Infant Feeding Index [ Time Frame: 36 months ]Collection of information on breastfeeding history, feeding practices, food frequency, and recent dietary history. This is a questionnaire to determine the child's availability to basic food sources.
- Family Care Indicators [ Time Frame: 36 months ]Questionnaire to indicate the basic resources available to the participant (i.e. housing, medical care, etc).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04888377
|United States, Alabama|
|University of Alabama, Birmingham|
|Birmingham, Alabama, United States, 35233|
|United States, Colorado|
|University of Colorado Health Sciences Center|
|Denver, Colorado, United States, 80208|
|United States, Delaware|
|Newark, Delaware, United States, 19718|
|United States, Massachusetts|
|Boston, Massachusetts, United States, 02115|
|United States, New York|
|New York, New York, United States, 10032|
|United States, North Carolina|
|University of North Carolina School of Medicine|
|Chapel Hill, North Carolina, United States, 27599|
|Research Triangle Park, North Carolina, United States, 27709|
|United States, Pennsylvania|
|Thomas Jefferson University|
|Philadelphia, Pennsylvania, United States, 19107|
|Congo, The Democratic Republic of the|
|Kinshasa School of Public Health|
|Kinshasa, Congo, The Democratic Republic of the|
|Guatemala City, Guatemala|
|Jawaharlal Nehru Medical College|
|Lata Medical Research Foundation|
|Aga Khan University|
|University Teaching Hospital|
|Principal Investigator:||Elizabeth McClure, PhD||RTI International|