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Multi Modal Stimulations in Pre-term Neonates

Primary Purpose

Preterm Birth, Infant, Premature, Diseases

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Sensory Stimulation
Movement therapy
Routine hospital care
Sponsored by
Asir John Samuel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Preterm Birth focused on measuring Preterm, Neonate, Multi-modal stimulation

Eligibility Criteria

2 Days - 28 Days (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Neonatal Intensive Care Unit, Maharishi Markandeshwar Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

experimental group

control group

Arm Description

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

receives routine care from the nursing team as well as daily maternal care, such as being held in the mother's arms

Outcomes

Primary Outcome Measures

Infant Neurological International Battery
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.

Secondary Outcome Measures

Full Information

First Posted
January 28, 2020
Last Updated
January 15, 2022
Sponsor
Asir John Samuel
Collaborators
Maharishi Markendeswar University (Deemed to be University)
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1. Study Identification

Unique Protocol Identification Number
NCT04247308
Brief Title
Multi Modal Stimulations in Pre-term Neonates
Official Title
Multi-modal Stimulations on Neuromotor Responses Among the Hospitalised Preterm Infants
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
October 30, 2021 (Actual)
Study Completion Date
December 13, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Asir John Samuel
Collaborators
Maharishi Markendeswar University (Deemed to be University)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Birth, Infant, Premature, Diseases
Keywords
Preterm, Neonate, Multi-modal stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two group pre-test post-test design
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
experimental group
Arm Type
Experimental
Arm Description
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
Arm Title
control group
Arm Type
Active Comparator
Arm Description
receives routine care from the nursing team as well as daily maternal care, such as being held in the mother's arms
Intervention Type
Other
Intervention Name(s)
Sensory Stimulation
Intervention Description
Auditory, tactile, visual, vestibular and oro motor stimulation
Intervention Type
Other
Intervention Name(s)
Movement therapy
Intervention Description
Passive range of movements, antigravity movements in prone and supine
Intervention Type
Other
Intervention Name(s)
Routine hospital care
Intervention Description
Maintaining the vitals
Primary Outcome Measure Information:
Title
Infant Neurological International Battery
Description
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.
Time Frame
Change from baseline and 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Days
Maximum Age & Unit of Time
28 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Infants born between 28 and 36 week of gestation Birth weight ranging from 1000-2500 g. Medically stable preterm infants Exclusion Criteria: Medically unstable preterm infants. Infants with congenital anomalies, congenital infections and central nervous system injury
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vencita P Aranha, MPT, (PhD)
Organizational Affiliation
Maharishi Markandeshwar Institute of physiotherapy and Rehabilitation, MM(DU)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Neonatal Intensive Care Unit, Maharishi Markandeshwar Hospital
City
Ambala
State/Province
Haryana
ZIP/Postal Code
133207
Country
India

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
http://data.mendeley.com/datasets/k4j689jfwj/2
Citations:
PubMed Identifier
34719445
Citation
Aranha VP, Chahal A, Bhardwaj AK. Neonatal aquatic physiotherapy in neonatal intensive care units: A scoping review. J Neonatal Perinatal Med. 2022;15(2):229-235. doi: 10.3233/NPM-210858.
Results Reference
background
PubMed Identifier
34864695
Citation
Aranha VP, Chahal A, Bhardwaj AK. Short-term effects of multimodal stimulation on neuromotor behaviour and neonatal pain among hospitalized preterm infants: A feasibility, non-blinded randomized controlled trial. J Neonatal Perinatal Med. 2023;16(2):325-337. doi: 10.3233/NPM-210889.
Results Reference
result
Links:
URL
http://content.iospress.com/articles/journal-of-neonatal-perinatal-medicine/npm210858
Description
Neonatal aquatic physiotherapy in neonatal intensive care units: A scoping review
URL
http://content.iospress.com/articles/journal-of-neonatal-perinatal-medicine/npm210889
Description
Short-term effects of multimodal stimulation on neuromotor behaviour and neonatal pain among hospitalized preterm infants: A feasibility, non-blinded randomized controlled trial
Available IPD and Supporting Information:
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
http://data.mendeley.com/datasets/k4j689jfwj/2
Available IPD/Information Identifier
Mendeley Data
Available IPD/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).

Learn more about this trial

Multi Modal Stimulations in Pre-term Neonates

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