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Testing Practicality and Acceptance of Early Stimulation Activities for Preterm Babies in Neonatal Intensive Care Units in Tamil Nadu

Multimodal Early Stimulation for Preterm Infants Admitted in Neonatal Intensive Care Unit: A Pilot Feasibility Non-Randomized Trial In Tamil Nadu Context - NIL

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/11/097095
Enrollment
80
Registered
2025-11-07
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

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

Intervention1: Multimodal Early Stimulation Program: Includes a parent delivered gestational week specific multimodal
early stimulation program, that will be designed by triangulated the existing evidence and the practice patterns of therapists in NICU, which will further be content validated for safety and feasibili

Sponsors

SRM Institute of Science and Technology
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Preterm infants born between the gestational age of 26 weeks and 35 weeks APGAR score greater than 7 at birth Haemodynamically stable preterm infants

Exclusion criteria

Exclusion criteria: Congenital anomalies Invasive ventilation Parents not willing to participate in the study Retinopathy of prematurity Bone fracture Intraventricular haemorrhage

Design outcomes

Primary

MeasureTime frame
Primary Feasibility Outcomes: •Recruitment and retention rates: •Descriptive statistics, which include percentages, means, and medians will be applied to summarize recruitment rates, participant retention, and attrition. •Therapy fidelity: Calculate adherence rates to the intervention protocol and assess deviations using proportions and confidence intervals.Timepoint: The test for feasibility will be assessed at the time of admission, every week after that, till the point of discharge. Retention rates will be assessed at the time of discharge Recruitment rate will be assessed at the time of admission

Secondary

MeasureTime frame
Neurodevelopmental Outcomes: Analyze Premie-Neuro Scale scores for pre- and post-intervention data. • Feeding Skills: Apply the Early Feeding Skill Scale. • Respiratory Status: Silverman Anderson Scores for changesTimepoint: At the time of admission and at the time of discharge

Countries

India

Contacts

Public ContactDr Vadivelan Kanniappan

SRM College of Physiotherapy, SRM Institute of Science and Technology

vadivelk@srmist.edu.in09841298555

Outcome results

None listed

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