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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.


Recruitment information / eligibility

Status Completed
Enrollment 666
Est. completion date June 15, 2022
Est. primary completion date June 15, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 33 Months to 39 Months
Eligibility Inclusion Criteria: - Mother was enrolled in the GN ASPIRIN trial - Mother consented to be recontacted - Child's parents or guardians are willing and able to give consent - Child is between 33-39 months of age - Child does not have significant congenital anomaly (blind or deaf) that would affect them from completing study assessments - Child does not have other medical conditions that would preclude the child from completing study assessments. Exclusion Criteria: - The child does not meet the inclusion criteria.

Study Design


Intervention

Drug:
Aspirin
Participant's mothers were administered 81mg of Aspirin throughout their pregnancy with the participant.
Placebo
Participant's mothers were administered placebo throughout their pregnancy with the participant.

Locations

Country Name City State
Congo, The Democratic Republic of the Kinshasa School of Public Health Kinshasa
Guatemala INCAP Guatemala City
India Jawaharlal Nehru Medical College Belgaum
India Lata Medical Research Foundation Nagpur
Pakistan Aga Khan University Karachi
United States University of Alabama, Birmingham Birmingham Alabama
United States Boston University Boston Massachusetts
United States University of North Carolina School of Medicine Chapel Hill North Carolina
United States University of Colorado Health Sciences Center Denver Colorado
United States Columbia University New York New York
United States Christiana Care Newark Delaware
United States Thomas Jefferson University Philadelphia Pennsylvania
United States RTI International Research Triangle Park North Carolina
Zambia University Teaching Hospital Lusaka

Sponsors (4)

Lead Sponsor Collaborator
NICHD Global Network for Women's and Children's Health RTI International, Thomas Jefferson University, Thrasher Research Fund

Countries where clinical trial is conducted

United States,  Zambia,  Congo, The Democratic Republic of the,  Guatemala,  India,  Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Other Infant Feeding Index 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. 36 months
Other Family Care Indicators Questionnaire to indicate the basic resources available to the participant (i.e. housing, medical care, etc). 36 months
Primary BSID-III Examination 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. 36 months
Secondary ASQ-3 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. 36 months
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