NCT04247308

Multi Modal Stimulations in Pre-term Neonates

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Asir John Samuel · Academic / Other
• Sex: All
• Age: 2 Days – 28 Days
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Preterm Birth
• Infant, Premature, Diseases

Interventions

Type	Name	Description
OTHER	Sensory Stimulation	Auditory, tactile, visual, vestibular and oro motor stimulation
OTHER	Movement therapy	Passive range of movements, antigravity movements in prone and supine
OTHER	Routine hospital care	Maintaining the vitals

Timeline

• Start date: 2020-10-01
• Primary completion: 2021-10-30
• Completion: 2021-12-13
• First posted: 2020-01-30
• Last updated: 2022-01-20

Locations

1 site across 1 country: India