MedTrace Logo

Multi Modal Stimulations in Pre-term Neonates

NCT04247308 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2022-01-20

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Maharishi Markendeswar University (Deemed to be University)

    collaborator OTHER

  • Asir John Samuel

    lead OTHER

Principal Investigators

  • Vencita P Aranha, MPT, (PhD) · Maharishi Markandeshwar Institute of physiotherapy and Rehabilitation, MM(DU)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
2 Days
Max Age
28 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-01
Primary Completion
2021-10-30
Completion
2021-12-13

Countries

  • India

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04247308 on ClinicalTrials.gov