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

Not Applicable

Completed

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

• Registration Number: CTRI/2021/06/034432
• Lead Sponsor: Thrasher Research Fund

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-03-30
• Last Update Posted: 13 November 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 4820

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

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).

Study & Design

• Study Type: Observational
• Study Design: Not specified