Multi Modal Stimulations in Pre-term Neonates

Not Applicable

Completed

• Conditions: Infant, Premature, Diseases; Preterm Birth
• Interventions: Other: Routine hospital care; Other: Sensory Stimulation; Other: Movement therapy

• Registration Number: NCT04247308
• Lead Sponsor: Asir John Samuel

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-28
• Study First Submitted QC: 2020-01-28
• Study First Posted: 2020-01-30
• Study Start: 2020-10-01
• Primary Completion: 2021-10-30
• Study Completion: 2021-12-13
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-15
• Last Update Posted: 2022-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

1. Infants born between 28 and 36 week of gestation
2. Birth weight ranging from 1000-2500 g.
3. Medically stable preterm infants

Exclusion Criteria

1. Medically unstable preterm infants.
2. Infants with congenital anomalies, congenital infections and central nervous system injury

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	Routine hospital care	receives routine care from the nursing team as well as daily maternal care, such as being held in the mother's arms
experimental group	Sensory Stimulation	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
experimental group	Movement therapy	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

Primary Outcome Measures

Name	Time	Method
Infant Neurological International Battery	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.

Trial Locations

Locations (1)

Neonatal Intensive Care Unit, Maharishi Markandeshwar Hospital; 🇮🇳 Ambala, Haryana, India