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Multi Modal Stimulations in Pre-term Neonates

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04247308
Recruitment Status : Suspended (Due to COVID-19 lockdown)
First Posted : January 30, 2020
Last Update Posted : June 16, 2020
Sponsor:
Collaborator:
Maharishi Markendeswar Institute of Medical Sciences and Research
Information provided by (Responsible Party):
Asir John Samuel, Maharishi Markendeswar University (Deemed to be University)

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.


Condition or disease Intervention/treatment Phase
Preterm Birth Infant, Premature, Diseases Other: Sensory Stimulation Other: Movement therapy Other: Routine hospital care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two group pre-test post-test design
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
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

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




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   up to 28 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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India
Neonatal Intensive Unit, Maharishi Markandeshwar Hospital
Ambala, Haryana, India, 133207
Sponsors and Collaborators
Asir John Samuel
Maharishi Markendeswar Institute of Medical Sciences and Research
Investigators
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Principal Investigator: Vencita P Aranha, MPT, (PhD) Maharishi Markandeshwar Institute of physiotherapy and Rehabilitation, MM(DU)
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Responsible Party: Asir John Samuel, Associate Professor, Maharishi Markendeswar University (Deemed to be University)
ClinicalTrials.gov Identifier: NCT04247308    
Other Study ID Numbers: MMDU/IEC/1566
U1111-1236-9478 ( Other Identifier: UTN by WHO International Clinical Trials Registry Platform )
First Posted: January 30, 2020    Key Record Dates
Last Update Posted: June 16, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Publication in Peer-Reviewed Indexed Journals
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Data will be available at the end of the study
Access Criteria: Mendeley data

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Asir John Samuel, Maharishi Markendeswar University (Deemed to be University):
Preterm
Neonate
Multi-modal stimulation
Additional relevant MeSH terms:
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Premature Birth
Infant, Premature, Diseases
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Infant, Newborn, Diseases