ASPIRIN: Neurodevelopmental Follow-up Trial

NCT ID: NCT04888377

Last Updated: 2024-10-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 666 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2022-06-15

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).

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 *NCT02409680* (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.

Conditions

Neurodevelopmental Abnormality

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Aspirin

Intervention Type: DRUG

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.

Placebo

Intervention Type: DRUG

Participant's mothers were administered placebo throughout their pregnancy with the participant.

Interventions

Aspirin

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

Intervention Type: DRUG

Placebo

Participant's mothers were administered placebo throughout their pregnancy with the participant.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 33 Months
• Maximum Eligible Age: 39 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Thomas Jefferson University

OTHER

Sponsor Role: collaborator

RTI International

OTHER

Sponsor Role: collaborator

Thrasher Research Fund

OTHER

Sponsor Role: collaborator

NICHD Global Network for Women's and Children's Health

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elizabeth McClure, PhD

Role: PRINCIPAL_INVESTIGATOR

RTI International

Locations

University of Alabama, Birmingham

Birmingham, Alabama, United States

University of Colorado Health Sciences Center

Denver, Colorado, United States

Christiana Care

Newark, Delaware, United States

Boston University

Boston, Massachusetts, United States

Columbia University

New York, New York, United States

University of North Carolina School of Medicine

Chapel Hill, North Carolina, United States

RTI International

Research Triangle Park, North Carolina, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Kinshasa School of Public Health

Kinshasa, , Democratic Republic of the Congo

INCAP

Guatemala City, , Guatemala

Jawaharlal Nehru Medical College

Belagavi, , India

Lata Medical Research Foundation

Nagpur, , India

Aga Khan University

Karachi, , Pakistan

University Teaching Hospital

Lusaka, , Zambia

Countries

United States; Democratic Republic of the Congo; Guatemala; India; Pakistan; Zambia

References

Hoffman MK, Goudar S, Dhaded S, Figueroa L, Mazariegos M, Krebs NF, Westcott J, Tikmani SS, Karim F, Saleem S, Goldenberg RL, Lokangaka A, Tshefu A, Bauserman M, Patel A, Das P, Hibberd P, Chomba E, Mwenchanya M, Carlo WA, Trotta M, Williams A, Moore J, Nolen T, Goco N, McClure EM, Lobo MA, Cunha AB, Derman RJ. Neurodevelopment of Children Whose Mothers Were Randomized to Low-Dose Aspirin During Pregnancy. Obstet Gynecol. 2024 Apr 1;143(4):554-561. doi: 10.1097/AOG.0000000000005514. Epub 2024 Jan 23.

Reference Type: DERIVED

PMID: 38262066 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

GN ASPIRIN Follow Up

Identifier Type: -

Identifier Source: org_study_id