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Clinical Trials/CTRI/2026/01/100659
CTRI/2026/01/100659Not yet recruitingNot Applicable

Effectiveness of Early Developmental Stimulation Among Late Preterm Infants

Revathi Rameandran1 site in 1 country50 target enrollmentStarted: January 20, 2026Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
50
Locations
1

Study Overview

Brief Summary

Late preterm infants born between 34 and 36 weeks of gestation are at higher risk of delayed feeding growth and neurodevelopment due to physiological immaturity. Early developmental stimulation using oromotor and kinesthetic techniques may help improve sucking ability weight gain muscle tone and motor development during early life. This prospective experimental study aims to evaluate the effectiveness of early developmental stimulation among late preterm infants. A total of 50 infants will be selected using convenience sampling and divided into an intervention group receiving early developmental stimulation and a control group receiving routine neonatal care. The intervention will be initiated within the first week of life and continued for a specified duration with regular monitoring of vital signs. Outcomes will be assessed using neurological motor and growth parameters. The study is expected to demonstrate that early developmental stimulation is a safe feasible and effective method to enhance neurodevelopmental outcomes in late preterm infants.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded

Eligibility Criteria

Ages
1.00 Day(s) to 3.00 Month(s) (—)
Sex
All

Inclusion Criteria

  • Gestational age at birth between 34 weeks to 36 weeks 6 days (i.e., Late Preterm Infants).
  • Admitted to NICU or postnatal ward within the study hospital during the data collection period.
  • Postnatal age: Infants enrolled within first 7 days of life.
  • comparison between HINE Scoring and GMFM.

Exclusion Criteria

  • structural abnormalities Infants with major congenital anomalies or known genetic syndromes (e.g., Down syndrome, Edward syndrome).
  • Recent surgeries.
  • Parents/guardians unwilling or unable to provide informed consent.

Investigators

Sponsor
Revathi Rameandran
Sponsor Class
Other [Other [Self] ]
Responsible Party
Principal Investigator
Principal Investigator

Revathi Ramendran

Saveetha College of Physiotherapy

Study Sites (1)

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