| CTRI Number |
CTRI/2021/07/034879 [Registered on: 15/07/2021] Trial Registered Prospectively |
| Last Modified On: |
14/07/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes
Behavioral
Other (Specify) [Multisensory intervention] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of multisensory intervention- auditory, tactile, visual, vestibular stimulation with maternal participation and guidance on the health outcomes- behavioral response, feeding progression and weight gain of preterm neonates at a selected hospital, Mangaluru. |
|
Scientific Title of Study
|
Effectiveness of multisensory intervention with maternal participatory guidance on the health status of preterm neonates at a selected hospital, Mangaluru |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| - |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sonya Sequeira |
| Designation |
Professor |
| Affiliation |
Yenepoya ( Deemed to be University), University road, Deralakatte, Mangaluru- 575018 |
| Address |
Pediatric Nursing Department, Zulekha Nursing College, Zulekha complex, Bibi Alabi road, Mangaluru-575001
Yenepoya Medical College and Hospital, University road, Deralakatte, Mangaluru-575018
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9738802075 |
| Fax |
- |
| Email |
soniariky@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R KANAGAVALLI |
| Designation |
Principal and Professor (Community health nursing dept.) |
| Affiliation |
Yenepoya (deemed to be University) |
| Address |
Zulekha complex, Bibi Alabi road, Bunder, Mangaluru
University road, Deralakatte, Mangaluru-575018
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9880531047 |
| Fax |
- |
| Email |
rkanaga.its@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prakash R M Saldanha |
| Designation |
Professor and Medical Superintendent |
| Affiliation |
Yenepoya Medical College and Hospital |
| Address |
Department of Pediatrics, Yenepoya Medical College and Hospital, University road, Deralakatte, Mangaluru
Yenepoya Medical College and Hospital, University road, Deralakatte, Mangaluru-575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9845081567 |
| Fax |
- |
| Email |
saldanha.drprakash@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yenepoya Medical College Hospital, University road, Deralakatte, Mangaluru-575018, Karnataka, India. |
|
|
Primary Sponsor
|
| Name |
Sonya Sequeira |
| Address |
Zulekha Nursing College
Zulekha complex
Bibi Alabi Road
Mangaluru-575001 |
| Type of Sponsor |
Other [Self sponsor] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Yenepoya Medical College Hospital |
University road, Deralakatte, Mangaluru-575018, Karnataka, India. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Prakash R M Saldanha |
Yenepoya Medical College Hospital |
Neonatal Intensive Care Unit, 3rd floor, A wing, University road, Deralakatte, Mangaluru-575018
Dakshina Kannada
KARNATAKA |
9845081567
-
saldanha.drprakask@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Yenepoya Ethics Committee-1 |
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 |
| Comparator Agent |
Control group |
Control group -preterm neonates will receive the routine NICU care. |
| Intervention |
Multisensory intervention( ATVV stimulation) |
EXPERIMENT GROUP: Multisensory intervention(Auditory,Tactile,Visual and Vestibular stimulation)for preterm neonates administered by mothers of preterm neonates under the guidance and supervision of the researcher along with routine NICU care
Control group: only routine NICU care |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
Preterm neonates,
• 28 -<32 weeks (very preterm) and 33 -<36 weeks
gestation (moderate to late preterm) at birth
as per modified Ballard score
• who are hemodynamically stable during
recruitment for study
• weighing≥1000 grams
Mothers,
• of preterm neonates
• who are willing to stay in the hospital with
preterm neonate for a minimum of 10 days after
being recruited in the study
• who are able to speak and read Kannada/
Malayalam/ English language |
|
| ExclusionCriteria |
| Details |
Preterm neonates,
• with congenital anomaly, necrotizing enterocolitis, brain injury, chronic lung disease
• with prenatal drug exposure
Mothers,
•not willing to participate in the study
•with psychological or psychiatric illness
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
preterm neonates,
behavioral state
feeding progression
weight gain |
day 1, day 5, day10
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="197"
Sample Size from India="197"
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)
|
01/08/2021 |
| 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="2"
Months="6"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The proposed study is a Randomised control trial on effectiveness of multisensory intervention with maternal participatory guidance on the health status of preterm neonates at a selected hospital, Mangaluru. Ethical clearance and required permissions for the study will be obtained appropriately. The preterm neonates and their mothers who fulfil the inclusion and exclusion criteria will be randomly assigned to the experimental (n=97) and control group (n=97) using simple random sampling technique. Informed consent will be obtained from the mothers. The preterm neonates in the experimental group will receive the multisensory intervention (ATVV stimulation) from the mothers which will be taught using a video, handout and guidance by the researcher along with routine NICU care. The control group will only receive routine NICU care. The experimental group will receive the multisensory intervention for 10 consecutive days and the observations will be done on the 1st, 5th and 10th days of intervention.The primary outcomes such as behavioural state, feeding progression and weight gain in preterm neonates will be assessed using the Andersons behavioural state scale, feeding progression scale for preterm neonates, weight record respectively. the gathered data will be subjected to statistical anlysis using repeated measures ANNOVA, Post-hoc analysis and Chi square test. |