Multi Modal Stimulations in Pre-term Neonates

Study Overview
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Brief Summary
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A total of 56 neonates with LBW will recruited by the convenience sampling to participate in this two group pre-test post-test, single blinded randomized clinical study. After the demographics, recruited NLBW will be randomly divided into two groups, group A and group B with block randomization. There will be four blocks, with the matrix design of 4X14 here 14 being rows. Each block contained 4 chits (2 chits for each group), totalling 56. The subjects will be allotted to the group based on the randomly chosen chit by their parents. Once the block will be allotted, next row block was opened. Thus, equal number of NLBW will be assigned to each group over time. Group A will be receiving multimodal sensory and kinesthetic stimulation (MSKS) and Group B will be receiving regular lifesaving hospital care. Group A will receive the interventions for 2 weeks period, totalling 10 sessions. Each session will last for 30 minutes duration.

Official Title
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Multi-modal Stimulations on Neuromotor Responses Among the Hospitalised Preterm Infants

Conditions
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Preterm Birth, Infant, Premature, Diseases

Intervention / Treatment
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* Other: Sensory Stimulation
* Other: Movement therapy
* Other: Routine hospital care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infants born between 28 and 36 week of gestation Birth weight ranging from 1000-2500 g. Medically stable preterm infants Exclusion Criteria: Medically unstable preterm infants. Infants with congenital anomalies, congenital infections and central nervous system injury

Ages Eligible for Study
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Minimum Age: 2 Days
Maximum Age: 28 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two group pre-test post-test design
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental group<br>Sensory stimulations (ATVV) will be consisting of Soft lullaby between of 30-40 dB for Auditory, Gentle stroking massage in supine position(upper and lower limb)for Tactile, Visual Stimulations with Black and white card (distance of 8-10 in), gentle rocking (vertical and horizontal direction) for the stimulation of vestibular system and oral stimulation including stocking cheeks, lips, jaw and tongue, rubbing gum.Each stimulation will be given for 3 minutes. Movement therapy will include: Guided range of motion: flexion-extension movements of lower limb (bicycle riding pattern). Hand should be placed around knee joint. Care must be taken as PI consist the cartilaginous joints at wrist and ankle. Anti gravity movements in prone (neck and spinal extension), Anti gravity movements in sitting (supported) and Upright positioning for 3min each | Other: Sensory Stimulation<br>* Auditory, tactile, visual, vestibular and oro motor stimulation<br>Other: Movement therapy<br>* Passive range of movements, antigravity movements in prone and supine<br>|
| Active Comparator: control group<br>receives routine care from the nursing team as well as daily maternal care, such as being held in the mother's arms | Other: Routine hospital care<br>* Maintaining the vitals<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infant Neurological International Battery | Infant Neurological International Battery (INFANIB), the minimum and maximum values are 14 and 70 respectively, and higher scores mean a better outcome. Scores less than and equal to 48 is abnormal while greater than and equal to 66 means normal. | Change from baseline and 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Preterm, Neonate, Multi-modal stimulation