ASPIRIN: Neurodevelopmental Follow-up Trial

NCT04888377 | Completed Results DMC

• 1 other identifier: GN ASPIRIN Follow Up
• Study Type: observational
• Target: 666
• Locations: 6 countries
• Sites: 14

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).

Conditions

Neurodevelopmental Abnormality

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Bayley Scales of Infant and Toddler Development, 3rd Edition (Bayley-III) Cognitive Composite Score

  Mean of the Bayley-III Cognitive Composite Score (standardized mean 100, SD 15, range 55-155) (lower scores indicating greater impairment)

  At a single visit occurring between 33-39 months corrected age

Secondary Outcomes (18)

• Bayley Scales of Infant and Toddler Development, 3rd Edition (Bayley-III) Cognitive Composite Score Less Than 70

  At a single visit occurring between 33-39 months corrected age

• Bayley Scales of Infant and Toddler Development, 3rd Edition (Bayley-III) Cognitive Composite Score Less Than 1 Standard Deviation (SD) Below the Mean

  At a single visit occurring between 33-39 months corrected age

• Bayley Scales of Infant and Toddler Development, 3rd Edition (Bayley-III) Language Composite Score

  At a single visit occurring between 33-39 months corrected age

• Bayley Scales of Infant and Toddler Development, 3rd Edition (Bayley-III) Language Composite Score Less Than 70

  At a single visit occurring between 33-39 months corrected age

• Bayley Scales of Infant and Toddler Development, 3rd Edition (Bayley-III) Language Composite Score Less Than 1 Standard Deviation (SD) Below the Mean

  At a single visit occurring between 33-39 months corrected age

Study Arms (2)

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

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

Interventions

Aspirin DRUG

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

Antenatal exposure to low dose aspirin

Placebo DRUG

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

Antenatal exposure to Placebo

Eligibility Criteria

• Age: 33 Months - 39 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

Sponsors & Collaborators

• NICHD Global Network for Women's and Children's Health: lead
• Thomas Jefferson University: collaborator
• RTI International: collaborator
• Thrasher Research Fund: collaborator

Study Sites (14)

University of Alabama, Birmingham

Birmingham, Alabama, 35233, United States

Location

University of Colorado Health Sciences Center

Denver, Colorado, 80208, United States

Location

Christiana Care

Newark, Delaware, 19718, United States

Location

Boston University

Boston, Massachusetts, 02115, United States

Location

Columbia University

New York, New York, 10032, United States

Location

University of North Carolina School of Medicine

Chapel Hill, North Carolina, 27599, United States

Location

RTI International

Research Triangle Park, North Carolina, 27709, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Kinshasa School of Public Health

Kinshasa, Democratic Republic of the Congo

Location

INCAP

Guatemala City, Guatemala

Location

Jawaharlal Nehru Medical College

Belagavi, India

Location

Lata Medical Research Foundation

Nagpur, India

Location

Aga Khan University

Karachi, Pakistan

Location

University Teaching Hospital

Lusaka, Zambia

Location

Related Publications (1)

• 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.

  PMID: 38262066 DERIVED

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Elizabeth McClure
• Organization: RTI International

mcclure@rti.org

919-316-3773

Study Officials

• Elizabeth McClure, PhD

  RTI International

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2021
• First Posted: May 17, 2021
• Study Start: September 1, 2021
• Primary Completion: June 15, 2022
• Study Completion: June 15, 2022
• Last Updated: October 21, 2024
• Results First Posted: October 21, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

GU (1); DE (1); US (8); IN (2); PA (1); ZA (1)