Multi Modal Stimulations in Pre-term Neonates

January 15, 2022 updated by: Asir John Samuel

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Haryana
      • Ambala, Haryana, India, 133207
        • Neonatal Intensive Care Unit, Maharishi Markandeshwar Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 days to 4 weeks (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from baseline and 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asir John Samuel

Collaborators

Maharishi Markendeswar University (Deemed to be University)

Investigators

  • Principal Investigator: Vencita P Aranha, MPT, (PhD), Maharishi Markandeshwar institute of physiotherapy and Rehabilitation, MM(DU)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2020

Primary Completion (Actual)

October 30, 2021

Study Completion (Actual)

December 13, 2021

Study Registration Dates

First Submitted

January 28, 2020

First Submitted That Met QC Criteria

January 28, 2020

First Posted (Actual)

January 30, 2020

Study Record Updates

Last Update Posted (Actual)

January 20, 2022

Last Update Submitted That Met QC Criteria

January 15, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MMDU/IEC/1566
  • U1111-1236-9478 (Other Identifier: UTN by WHO International Clinical Trials Registry Platform)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Publication in Peer-Reviewed Indexed Journals

IPD Sharing Time Frame

Data will be available at the end of the study

IPD Sharing Access Criteria

Mendeley data

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)

Study Data/Documents

  1. Individual Participant Data Set
    Information identifier: Mendeley Data
    Information comments: Contains 56 Preterm Infants data which includes, gestational age, chronological age, corrected gestational age, sex, birth weight, birth length, birth occipitofrontal circumference (OFC), APGAR at 1-min, and APGAR at 5-min, pre-post intervention (5 days) changes of weight, length, OFC, INFANIB (Infant Neurological International Battery) and NIPS (Neonatal Infant Pain Scale).

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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