- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04888377
ASPIRIN: Neurodevelopmental Follow-up Trial
Aspirin Supplementation for Pregnancy Indicated Risk Reduction in Nulliparas (ASPIRIN): Neurodevelopmental Follow-up Trial
Study Overview
Status
Conditions
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
Enrollment (Actual)
Contacts and Locations
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
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Congenital Abnormalities
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Platelet Aggregation Inhibitors
- Cyclooxygenase Inhibitors
- Antipyretics
- Aspirin
Other Study ID Numbers
- GN ASPIRIN Follow Up
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Neurodevelopmental Abnormality
-
Sharp HealthCareCompletedNeurodevelopmental AbnormalityCanada, United States, Poland
-
Central Hospital, Nancy, FranceCompletedLong-term Neurodevelopmental Disorders of Prematurely Born Children and Parental Experience (PREMA7)Neurodevelopmental AbnormalityFrance
-
Helsinki University Central HospitalUniversity of Helsinki; Tampere University; Aalto UniversityRecruitingNeurodevelopmental Disorders | Child Development | Developmental Delay | Development, Infant | Neurophysiologic Abnormality | Cognitive Developmental DelayFinland
-
University Hospital PadovaUniversity of PadovaRecruitingInfant Development | Neurodevelopmental Abnormality | Hypoglycemia NeonatalItaly
-
Sharp HealthCareUniversity of Alabama at Birmingham; University of Pittsburgh; University of... and other collaboratorsRecruitingNeurodevelopmental AbnormalityUnited States, Ireland, Canada, Germany
-
University Children's Hospital, ZurichUniversity of Lausanne Hospitals; University of Bern; University of Geneva, SwitzerlandRecruitingCongenital Heart Disease | Cardiac Disease | Neurodevelopmental Abnormality | Intensive Care Neurological DisorderSwitzerland
-
Kanuni Sultan Suleyman Training and Research HospitalCompletedNeurodevelopmental Abnormality | Transient Hypothyroxinemia of PrematurityTurkey
-
Windward Islands Research and Education FoundationNational Institutes of Health (NIH); Stanford University; St. George's UniversityCompletedNeurocognitive Deficit | Zika Virus Infection | Development, Child | Neurodevelopmental AbnormalityGrenada
-
Children's Hospital Los AngelesUniversity of Pittsburgh; Arizona State UniversityRecruitingPremature Birth | Neurodevelopmental Disorders | Brain Lesion | Brain Development AbnormalityUnited States
-
Thomas Jefferson UniversityJawaharlal Nehru Medical College; S. Nijalingappa Medical College; Raichur Institute...Active, not recruitingAutism Spectrum Disorder | Iron Deficiency Anemia | Neurodevelopmental AbnormalityIndia
Clinical Trials on Aspirin
-
The First Affiliated Hospital with Nanjing Medical...UnknownCoronary AtherosclerosisChina
-
Seoul National University HospitalCKD Pharmaceutical LimitedCompleted
-
Queen Mary University of LondonCancer Research UK; Barts and the London School of Medicine and DentistryCompletedProstate CancerUnited Kingdom
-
FANG HERecruitingPreeclampsia | Perinatal HaemorrhageChina
-
University of VigoRecruiting
-
Seoul National University HospitalCompletedCoronary Artery DiseaseKorea, Republic of
-
Johns Hopkins UniversityNational Heart, Lung, and Blood Institute (NHLBI)RecruitingPulmonary Disease, Chronic ObstructiveUnited States
-
Seoul National University HospitalCompletedHealthyKorea, Republic of
-
PLx PharmaCompletedDiabetes Mellitus, Type 2United States
-
Boehringer IngelheimCompletedCoronary ArteriosclerosisIreland