| CTRI Number |
CTRI/2023/08/057016 [Registered on: 29/08/2023] Trial Registered Prospectively |
| Last Modified On: |
27/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Multi sensory stimulation] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Usefulness of multisensory stimulation on motor and mental development, behavioural status, physical growth and physiological parameters in preterm neonates. A Randomized controlled trial. |
|
Scientific Title of Study
|
Effect of multisensory stimulation on motor and mental development, behavioural status, physical growth and physiological parameters in preterm neonates. A Randomized controlled trial. |
| Trial Acronym |
No |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr P Vetriselvi |
| Designation |
Assistant Professor |
| Affiliation |
JAWAHARLAL INSTITUTE OF POSTGRADUATE MEDICAL EDUCATION & RESEARCH INSTITUTE |
| Address |
College of Nursing
JIPMER
Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9894459434 |
| Fax |
|
| Email |
Vetriselvijipmer1967@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vanitha N |
| Designation |
Tutor |
| Affiliation |
JAWAHARLAL INSTITUTE OF POSTGRADUATE MEDICAL EDUCATION & RESEARCH INSTITUTE |
| Address |
College of Nursing
JIPMER
Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8056886180 |
| Fax |
|
| Email |
vanithasrinivasan22@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr P Vetriselvi |
| Designation |
Assistant Professor |
| Affiliation |
JAWAHARLAL INSTITUTE OF POSTGRADUATE MEDICAL EDUCATION & RESEARCH INSTITUTE |
| Address |
College of Nursing
JIPMER
Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9894459434 |
| Fax |
|
| Email |
Vetriselvijipmer1967@gmail.com |
|
|
Source of Monetary or Material Support
|
| INTRAMURAL FUND COMMITTEE JAWAHARLAL INSTITUTE OF POSTGRADUATE MEDICAL EDUCATION AND RESEARCH PUDUCHERRY-605006 |
|
|
Primary Sponsor
|
| Name |
JIPMER |
| Address |
INTRAMURAL COMMITTEE JAWAHARLAL INSTITUTE OF POSTGRADUATE MEDICAL EDUCATION & RESEARCH, PUDUCHERRY.605006 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr P Vetriselvi |
JIPMER |
Department of Neonatology,Intensive Care Unit, WCH Block, JIPMER, Puducherry . 605006.
Pondicherry
PONDICHERRY |
9894459434
Vetriselvijipmer1967@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| InstituteEthicsCommitteeForHumanStudies,JIPMER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P073||Preterm [premature] newborn [other], |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Multisensory stimulation |
For infants born at 34-37 weeks, stimulation will be started after 48 hours of birth. The stimulations were given during quiet alert state of preterm infant approximately 30 minutes before feeding. Stimulations were given for duration of 21 minutes twice daily, from day 1 to day 10. The following multisensory stimuli will be given. A)Tactile stimulation: This is done in the prone position. Twelve firm strokes with palms of the hands each, were provided in each area as follows: (a) Head from forehead hairline over scalp down to neck with alternate hands; (b) Neck from midline outwards with both hands simultaneously; (c) Shoulders from midline outwards with both hands simultaneously; and (d) Back from nape of neck down to buttocks with firm, long stroke with alternate hands for 5 minutes. Tactile stimulation, this is done in supine position with 12 gentle moderate pressure linear stroking massage will be performed on infant for 5 minutes in the sequence of fore head, chest, abdomen, upper limbs and lower limbs. B)Kinesthetic Stimulation: This is done in the supine position and consisted of passive flexion and extension movements of the limbs for 5 minutes. C)Visual Stimulation: Black and white visual stimulation card hung at a distance of 8–10 inches. from the neonate for 3 minutes. D)Vestibular stimulation, gentle horizontal and linear rocking will be given for 3 minutes. |
| Comparator Agent |
Routine care |
For infants born at 34-37 weeks, stimulation will be started after 48 hours of birth. The stimulations were given during quiet alert state of preterm infant approximately 30 minutes before feeding. Stimulations were given for duration of 21 minutes twice daily, from day 1 to day 10. The following multisensory stimuli will be given.
A)Tactile stimulation: This is done in the prone position. Twelve firm strokes with palms of the hands each, were provided in each area as follows: (a) Head from forehead hairline over scalp down to neck with alternate hands; (b) Neck from midline outwards with both hands simultaneously; (c) Shoulders from midline outwards with both hands simultaneously; and (d) Back from nape of neck down to buttocks with firm, long stroke with alternate hands for 5 minutes.
Tactile stimulation, this is done in supine position with 12 gentle moderate pressure linear stroking massage will be performed on infant for 5 minutes in the sequence of fore head, chest, abdomen, upper limbs and lower limbs.
B)Kinesthetic Stimulation: This is done in the supine position and consisted of passive flexion and extension movements of the limbs for 5 minutes.
C)Visual Stimulation: Black and white visual stimulation card hung at a distance of 8–10 inches. from the neonate for 3 minutes.
D)Vestibular stimulation, gentle horizontal and linear rocking will be given for 3 minutes.
And for control group routine care will be given. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
Inclusion Criteria:
1.Neonates delivered between 34-37 weeks of gestation
2.Neonates who are hemodynamically stable.
|
|
| ExclusionCriteria |
| Details |
Exclusion Criteria:
Neonates with any of the following criteria,
1.Neonates with weight <1000gm.
2.Neonates with weight >2500gm.
3.Neonates with major congenital anomalies.
4.Neonates who have undergone surgery.
5.Neonates who are critically ill.
6.Neonates who are on oxygen therapy.
7.Neonates with hypoxic encephalopathy.
8.Neonates with hypoglycemic seizures
9.significant birth trauma.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
•To assess the effect of multisensory stimulation on behavioural status among preterm infants.
•To assess the effect of multisensory stimulation on physical growth (Weight, Length, Head circumference) among preterm infants.
•To assess the effect of multisensory stimulation on physiological parameters (Heart rate, Respiratory rate, SpO2, Temperature).
|
Day 1,Day10, Week 40. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• To assess the effect of multisensory stimulation on motor & mental development among preterm infants at 3 month & 6 month.
• To identify the clinical characteristics associated with developmental, behavioural, physical & physiological outcome among the preterm neonates.
|
3rd month, 6th month. |
|
|
Target Sample Size
|
Total Sample Size="212"
Sample Size from India="212"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
06/09/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is the randomized control trial to know the effect of multisensory stimulation on motor and mental development, behavioural status, physical growth and physiological parameters in preterm neonates. Clinical characteristics of neonate will be collected from the case sheet. According to the sequence order the subject will be allocate to the experimental and control group. The Experimental group will receive multisensory stimulation for 10 days. In both the groups physical growth will be assessed on day 10 & the corrected gestational age of 40 weeks then once a month till 6 months. Physiological parameters will be assessed daily till discharge.Behavioural status will also be assessed daily till discharge.Motor and mental development will be assessed at 3rd month &6th month. |