Multi Modal Stimulations in Pre-term Neonates
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|ClinicalTrials.gov Identifier: NCT04247308|
Recruitment Status : Suspended (Due to COVID-19 lockdown)
First Posted : January 30, 2020
Last Update Posted : June 16, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Preterm Birth Infant, Premature, Diseases||Other: Sensory Stimulation Other: Movement therapy Other: Routine hospital care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||56 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Two group pre-test post-test design|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||Multi-modal Stimulations to Modify the Neuromotor Behaviour of Hospitalized Preterm Neonates|
|Estimated Study Start Date :||August 14, 2020|
|Estimated Primary Completion Date :||October 12, 2020|
|Estimated Study Completion Date :||November 21, 2020|
Experimental: experimental group
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
Auditory, tactile, visual, vestibular and oro motor stimulation
Other: Movement therapy
Passive range of movements, antigravity movements in prone and supine
Active Comparator: control group
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
Maintaining the vitals
- Infant Neurological International Battery [ Time Frame: Change from baseline and 2 weeks ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04247308
|Neonatal Intensive Unit, Maharishi Markandeshwar Hospital|
|Ambala, Haryana, India, 133207|
|Principal Investigator:||Vencita P Aranha, MPT, (PhD)||Maharishi Markandeshwar Institute of physiotherapy and Rehabilitation, MM(DU)|