Development, Validation and Feasibility testing of Multimodal Early Stimulation Program for Preterm Infants in Neonatal Intensive Care Unit
Overview
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- NA
- Enrollment
- 38
- Locations
- 1
- Primary Endpoint
- Feasibility of Multimodal Early Stimulation Program (Adherence rate, acceptance rate, attrition rate, clinical fidelity, ease of performance, deviations from the protocol and adverse events)
Overview
Brief Summary
This study will commence recruiting preterm infants once a panel of experts validates the developed protocol to ensure it is safe to be implemented on the babies. This study will evaluate the feasibility of applying a gestational week-specific comprehensive early stimulation protocol in real-world settings, especially in low and middle-income countries. The findings of this study will help in designing future randomised control trials ensuring quality care
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 1.00 Day(s) to 90.00 Day(s) (—)
- Sex
- All
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
- •Congenital anomalies Invasive ventilation Parents not willing to participate in the study Retinopathy of prematurity Bone fracture Intraventricular haemorrhage.
Outcomes
Primary Outcomes
Feasibility of Multimodal Early Stimulation Program (Adherence rate, acceptance rate, attrition rate, clinical fidelity, ease of performance, deviations from the protocol and adverse events)
Time Frame: Every 7th day. From enrollment to discharge | Baseline and endline will be taken
Secondary Outcomes
- Content Validity of the developed protocol (Multimodal Early Stimulation Program)(2 weeks)
Investigators
Abishek J R
SRM College of Physiotherapy, SRM Institute of Science and Technology