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ASPIRIN: Neurodevelopmental Follow-up Trial

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ClinicalTrials.gov Identifier: NCT04888377
Recruitment Status : Not yet recruiting
First Posted : May 17, 2021
Last Update Posted : June 11, 2021
Sponsor:
Collaborators:
Thomas Jefferson University
RTI International
Thrasher Research Fund
Information provided by (Responsible Party):
NICHD Global Network for Women's and Children's Health

Brief 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).

Condition or disease Intervention/treatment
Neurodevelopmental Abnormality Drug: Aspirin Drug: Placebo

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.

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Study Type : Observational
Estimated Enrollment : 620 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Aspirin Supplementation for Pregnancy Indicated Risk Reduction in Nulliparas (ASPIRIN): Neurodevelopmental Follow-up Trial
Estimated Study Start Date : September 2021
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : August 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.

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



Information from the National Library of Medicine

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Ages Eligible for Study:   33 Months to 39 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Elizabeth McClure, PhD 919-316-3773 mcclure@rti.org
Contact: Matthew Hoffman, MD 302-733-6510

Locations
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United States, Alabama
University of Alabama, Birmingham
Birmingham, Alabama, United States, 35233
Contact: Wally Carlo, MD       wcarlo@peds.uab.edu   
Principal Investigator: Wally Carlo, MD         
United States, Colorado
University of Colorado Health Sciences Center
Denver, Colorado, United States, 80208
Contact: Nancy Krebs, MD       Nancy.krebs@ucdenver.edu   
Principal Investigator: Nancy Krebs, MD         
United States, Delaware
Christiana Care
Newark, Delaware, United States, 19718
Contact: Matthew Hoffman, MD       Mhoffman@christianacare.org   
Principal Investigator: Matthew Hoffman, MD         
United States, Massachusetts
Boston University
Boston, Massachusetts, United States, 02115
Contact: Patricia L. Hibberd, MD, PhD    617-636-2431    plh0@bu.edu   
Principal Investigator: Patricia L. Hibberd, MD, PhD         
United States, New York
Columbia University
New York, New York, United States, 10032
Contact: Robert Goldenberg, MD       rlg88@columbia.edu   
Principal Investigator: Robert Goldenberg, MD         
United States, North Carolina
University of North Carolina School of Medicine
Chapel Hill, North Carolina, United States, 27599
Contact: Melissa Bauserman, MD       mbauserman@med.unc.edu   
Principal Investigator: Melissa Bauserman, MD         
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Contact: Richard Derman, MD, MPH       Richard.Derman@jefferson.edu   
Principal Investigator: Richard Derman, MD, MPH         
Congo, The Democratic Republic of the
Kinshasa School of Public Health
Kinshasa, Congo, The Democratic Republic of the
Contact: Antoinette Tshefu, MD, MPH, PhD       antotshe@yahoo.com   
Principal Investigator: Antoinette Tshefu, MD         
Principal Investigator: Melissa Bauserman, MD         
Guatemala
INCAP
Guatemala City, Guatemala
Contact: Manolo Mazariegos, MD    011-502-849-8892    mmazarie@turbonett.com   
Principal Investigator: Nancy Krebs, MD         
Principal Investigator: Manolo Mazariegos, MD         
India
Jawaharlal Nehru Medical College
Belgaum, India
Contact: Shivaprasad S Goudar, MD       sgoudar@jnmc.edu   
Principal Investigator: Shivaprasad Goudar, MD         
Principal Investigator: Richard Derman, MD         
Lata Medical Research Foundation
Nagpur, India
Contact: Archana Patel, MD       dr_apatel@yahoo.com   
Principal Investigator: Archana Patel, MD         
Principal Investigator: Patricia Hibberd, MD         
Pakistan
Aga Khan University
Karachi, Pakistan
Contact: Sarah Saleem, M.D.       sarah.saleem@aku.edu   
Principal Investigator: Robert Goldenberg, M.D.         
Principal Investigator: Sarah Saleem, M.D.         
Zambia
University Teaching Hospital
Lusaka, Zambia
Contact: Elwyn Chomba, MBChB       echomba@zamnet.zm   
Principal Investigator: Elwyn Chomba, MBChB         
Principal Investigator: Wally Carlo, MD         
Sponsors and Collaborators
NICHD Global Network for Women's and Children's Health
Thomas Jefferson University
RTI International
Thrasher Research Fund
Investigators
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Principal Investigator: Elizabeth McClure, PhD RTI International
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Responsible Party: NICHD Global Network for Women's and Children's Health
ClinicalTrials.gov Identifier: NCT04888377    
Other Study ID Numbers: GN ASPIRIN Follow Up
First Posted: May 17, 2021    Key Record Dates
Last Update Posted: June 11, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The plan is to release primary results from the study.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by NICHD Global Network for Women's and Children's Health:
Pre-eclampsia
Low Dose Aspirin
ASPIRIN Trail
NICHD Global Network
Global Network
ASPRIN Follow Up
BSID-III
Family Resources and Context
ASQ-36
Neurodevelopmental delays
hypertensive disorders of pregnancy (HDP)
Pre-term birth
LDA
Additional relevant MeSH terms:
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Congenital Abnormalities
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics