| CTRI Number |
CTRI/2025/02/081198 [Registered on: 24/02/2025] Trial Registered Prospectively |
| Last Modified On: |
11/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Screening |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Changes in Brain parameters via EEG compared between Father and Mother when they provide Kangaroo Mother care to their newborn |
|
Scientific Title of Study
|
To study Paternal versus Maternal Kangaroo Care and its Impact on
amplitude integrated EEG changes in stable Preterm Neonates |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR SOMASHEKHAR NIMBALKAR |
| Designation |
Professor and Head |
| Affiliation |
Pramukh Swami Medical College Karamsad Anand Gujarat |
| Address |
Department of Neonatology ,Pramukhswami Medical College Karamsad Anand Gujarat
Anand
GUJARAT
388325
India |
| Phone |
8319282631 |
| Fax |
|
| Email |
somu_somu@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ashutosh Sharma |
| Designation |
Senior Resident |
| Affiliation |
Pramukh Swami Medical College Karamsad Anand Gujarat |
| Address |
Department of Neonatology ,Pramukhswami Medical College Karamsad Anand Gujarat
Anand
GUJARAT
388325
India |
| Phone |
8319282631 |
| Fax |
|
| Email |
ashutosh.sharma027@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SOMASHEKHAR NIMBALKAR |
| Designation |
Professor and Head |
| Affiliation |
Pramukh Swami Medical College Karamsad Anand Gujarat |
| Address |
Department of Neonatology ,Pramukhswami Medical College Karamsad Anand Gujarat
GUJARAT
388325
India |
| Phone |
8319282631 |
| Fax |
|
| Email |
somu_somu@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Bhaikaka University, Gokalnagar, Karamsad, Anand-Sojitra Road, Pin -388325 |
|
|
Primary Sponsor
|
| Name |
Bhaikaka University |
| Address |
Bhaikaka University ,Pramukhswami Medical College Karamsad Anand Gujarat 388325 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Somashekhar Nimbalkar |
Pramukhswami Medical College |
Room Number 1 first floor NICU Pramukhswami Medical college Karamsad Anand Gujarat 388325
Anand
GUJARAT |
9825087842
somu_somu@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC - Bhaikaka University |
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 |
Amplitude integrated Electrencephalogram in preterm with Maternal KMC |
preterm baby Less than 37 weeks gestation age kept in KMC care after Feed for 2 hours and amplitude integrated Electroencephalography done during 2 hours of KMC session |
| Comparator Agent |
amplitude Integrated Electroencephalogram during paternal KMC |
Preterm Neonate less than 37 weeks receiving KMC after feed for 2 hour ,aEEG will be placed and recorded |
|
|
Inclusion Criteria
|
| Age From |
7.00 Day(s) |
| Age To |
14.00 Day(s) |
| Gender |
Both |
| Details |
preterm patient who are stable less than 37 weeks gestation age |
|
| ExclusionCriteria |
| Details |
preterm patient who have congenital anamoly and having seizure,and chromosomal abnormality, non consent from parent |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Amplitude Highest and lowest,Bandwidth,sleep wake up cycle,background pattern |
One hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| EEG score calculation |
2 hourly till age of 14 days postnatal age |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
03/03/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
aiEEG has been ued in our Unit for quite sometime and we have been doing KMC related studies for sometime. We felt that knowing changes in aiEEG during KMC would be important for understanding how it impacts the brain as studies in these fields are very few.
|