ASPIRIN: Neurodevelopmental Follow-up Trial

Aspirin Supplementation for Pregnancy Indicated Risk Reduction in Nulliparas (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 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).

Study Overview

Status

Completed

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

666

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Kinshasa, Congo, The Democratic Republic of the
        • Kinshasa School of Public Health
      • Guatemala City, Guatemala
        • INCAP
      • Belgaum, India
        • Jawaharlal Nehru Medical College
      • Nagpur, India
        • Lata Medical Research Foundation
      • Karachi, Pakistan
        • Aga Khan University
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama, Birmingham
    • Colorado
      • Denver, Colorado, United States, 80208
        • University of Colorado Health Sciences Center
    • Delaware
      • Newark, Delaware, United States, 19718
        • Christiana Care
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Boston University
    • New York
      • New York, New York, United States, 10032
        • Columbia University
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina School of Medicine
      • Research Triangle Park, North Carolina, United States, 27709
        • RTI International
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University
      • Lusaka, Zambia
        • University Teaching Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 3 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The study population will consist of approximately 620 children, between 33 and 39 months of age, whose mothers were included in the ASPIRIN trial.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
36 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
36 months
Family Care Indicators
Time Frame: 36 months
Questionnaire to indicate the basic resources available to the participant (i.e. housing, medical care, etc).
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2021

Primary Completion (Actual)

June 15, 2022

Study Completion (Actual)

June 15, 2022

Study Registration Dates

First Submitted

April 28, 2021

First Submitted That Met QC Criteria

May 12, 2021

First Posted (Actual)

May 17, 2021

Study Record Updates

Last Update Posted (Actual)

June 27, 2022

Last Update Submitted That Met QC Criteria

June 24, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The plan is to release primary results from the study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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