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Clinical Trials/CTRI/2024/07/071284
CTRI/2024/07/071284
Completed
Not Applicable

Neurodevelopmental Outcomes of Preterm and Low Birth Weight Infants at 3 years in Belagavi City – An Observational Study

Sinchana L1 site in 1 country49 target enrollmentStarted: August 1, 2024Last updated:

Overview

Phase
Not Applicable
Status
Completed
Sponsor
Sinchana L
Enrollment
49
Locations
1
Primary Endpoint
Bayley Scales of Infant & Toddler Development

Overview

Brief Summary

In India, research shows that premature and low birth weight infants may have developmental issues. Monitoring their development until preschool age is crucial. A widely used tool is available to assess cognitive, motor, language, and social-emotional development, aiding in early identification. The purpose of this study is to understand their long-term developmental needs using BSID-IV in India.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
3.00 Year(s) to 3.11 Year(s) (—)
Sex
All

Inclusion Criteria

  • Male and female children at 3 years of age .
  • Preterm less than 37 weeks of gestation and low birth weight infants who visited the high-risk baby clinic/maternal care unit at a hospital, Belagavi presently residing in Belagavi City.
  • Parent of the child willing to participate in the study and to come to tertiary care hospital, Belagavi.

Exclusion Criteria

  • Children who are critically ill or with genetic disorders, congenital anomalies, metabolic diseases.
  • Children with known neuromotor disabilities.

Outcomes

Primary Outcomes

Bayley Scales of Infant & Toddler Development

Time Frame: Baseline

(BSID 4)

Time Frame: Baseline

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Sinchana L
Sponsor Class
Other [Self sponsored]
Responsible Party
Principal Investigator
Principal Investigator

Sinchana L

KAHER Institute of Physiotherapy

Study Sites (1)

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