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Preterm Birth Prevention Study follow-up in looking at Neurodevelopmental delay

Aspirin Supplementation for Pregnancy Indicated Risk Reduction in Nulliparas (ASPIRIN): Neurodevelopmental Follow-up Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2021/06/034432
Enrollment
620
Registered
2021-06-28
Start date
Unknown
Completion date
Unknown
Last updated
2023-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: P073- Preterm [premature] newborn [other]

Interventions

None listed

Sponsors

Thrasher Research Fund
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. For a prior study sponsored by the Global Network for Women’s and Children’s Health Research, the child’s parents gave permission to re-contact. 2. The child’s parent/guardian is willing and able to provide consent for the child and willing also to participate in the child’s assessment (e.g., by providing answers to ASQ-3 and the Family Resources and Context questionnaire). 3. The child will be between 33 and 39 months of age at time of assessment. 4. The child does not have a significant congenital anomaly (e.g., blindness or deafness) that would affect development or preclude them from completing the BSID-III. This will be left at the discretion of the Senior Foreign Investigator (SFI) with the ability to consult with the Working Committee as needed. 5. Other significant medical conditions that would preclude the child from completing a BSID III are absent. This will be left to the discretion of the Senior Foreign Investigator who will have the ability to consult with the Working Committee as needed.

Exclusion criteria

Exclusion criteria: Children not meeting the inclusion criteria will be excluded. Likewise, children may be excluded at the discretion of the site investigator out of concern for the child’s wellbeing (e.g. distress with testing).

Design outcomes

Primary

MeasureTime frame
Results of the BSID-III- specifically the motor, cognitive and language componentsTimepoint: up to 39 months of life

Secondary

MeasureTime frame
Outcomes of Ages and Stages Questionaire-3Timepoint: up to 39 months of life;Record family care indicators and resources to understand the family contextTimepoint: up to 39 months of life

Countries

Democratic Republic of the Congo, Guatemala, India, Pakistan, Zambia

Contacts

Public ContactDr Shivaprasad S Goudar

KLE Academy of Higher Education and Researchs J N Medical College

sgoudar@jnmc.edu9448126371

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026