Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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)

Tracking Information
First Submitted Date  ICMJE January 28, 2020
First Posted Date  ICMJE January 30, 2020
Last Update Posted Date June 16, 2020
Estimated Study Start Date  ICMJE August 14, 2020
Estimated Primary Completion Date October 12, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 29, 2020)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 28, 2020)
INFANIB [ Time Frame: Change from baseline and 2 weeks ]
Infant Neurological International Battery
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Multi Modal Stimulations in Pre-term Neonates
Official Title  ICMJE Multi-modal Stimulations to Modify the Neuromotor Behaviour of Hospitalized Preterm Neonates
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Two group pre-test post-test design
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE
  • Preterm Birth
  • Infant, Premature, Diseases
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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

    Interventions:
    • Other: Sensory Stimulation
    • Other: Movement therapy
  • 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
    Intervention: Other: Routine hospital care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: January 28, 2020)
56
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 21, 2020
Estimated Primary Completion Date October 12, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 28 Days   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04247308
Other Study ID Numbers  ICMJE MMDU/IEC/1566
U1111-1236-9478 ( Other Identifier: UTN by WHO International Clinical Trials Registry Platform )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Publication in Peer-Reviewed Indexed Journals
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Time Frame: Data will be available at the end of the study
Access Criteria: Mendeley data
Responsible Party Asir John Samuel, Maharishi Markendeswar University (Deemed to be University)
Study Sponsor  ICMJE Asir John Samuel
Collaborators  ICMJE Maharishi Markendeswar Institute of Medical Sciences and Research
Investigators  ICMJE
Principal Investigator: Vencita P Aranha, MPT, (PhD) Maharishi Markandeshwar Institute of physiotherapy and Rehabilitation, MM(DU)
PRS Account Maharishi Markendeswar University (Deemed to be University)
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP