| CTRI Number |
CTRI/2024/04/065577 [Registered on: 12/04/2024] Trial Registered Prospectively |
| Last Modified On: |
11/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [COCONUT OIL APPLICATION] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Benefits of coconut oil application in preterm receiving KMC |
|
Scientific Title of Study
|
Changes in lipid profile and weight gain with coconut oil skin application in preterm neonates on Kangaroo Mother Care: A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bhaswati Ghoshal |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
CALCUTTA NATIONAL MEDICAL COLLEGE |
| Address |
Ghoshal Bari,Uttar Biresh pally,Madhyamgram,Kolkata -129
Ghoshal Bari,Uttar Biresh pally,Madhyamgram,Kolkata -129
Kolkata
WEST BENGAL
700129
India |
| Phone |
08056117284 |
| Fax |
|
| Email |
bhaswatighoshalmailme@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR. Pramita Das |
| Designation |
Senior Resident |
| Affiliation |
CALCUTTA NATIONAL MEDICAL COLLEGE |
| Address |
8 criper by lane, south, rajarshi apartment 1st floor..
Konnagar, hooghly
712235
Hugli
WEST BENGAL
712235
India |
| Phone |
7003052174 |
| Fax |
|
| Email |
promitadas19@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Bhaswati Ghoshal |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
CALCUTTA NATIONAL MEDICAL COLLEGE |
| Address |
Ghoshal Bari,Uttar Biresh pally,Madhyamgram,Kolkata -129
Ghoshal Bari,Uttar Biresh pally,Madhyamgram,Kolkata -129
Kolkata
WEST BENGAL
700129
India |
| Phone |
08056117284 |
| Fax |
|
| Email |
bhaswatighoshalmailme@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Calcutta National Medical College |
| Hospital supply and study participants will buy personally after discharge |
|
|
Primary Sponsor
|
| Name |
Calcutta National Medical College |
| Address |
32,GORACHAND ROAD KOLKATA 700014
West Bengal
India |
| Type of Sponsor |
Government 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 |
| Dr BHASWATI GHOSHAL |
CALCUTTA NATIONAL MEDICAL COLLEGE |
32 GORACHAND ROAD,BENIAPUKUR ,KOKATA 700014
Kolkata
WEST BENGAL |
08056117284
bhaswatighoshalmailme@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE,CALCUTTA NATIONAL MEDICAL COLLEGE (EC-CNMC) |
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 |
Coconut oil application |
application of coconut oil since birth to 2 months post discharge in pre term neonates along with kangaroo mother care |
| Comparator Agent |
no coconut oil application |
ONLY kangaroo mother care since birth to 2 months post discharge in pre term neonates |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
3.00 Month(s) |
| Gender |
Both |
| Details |
all preterm neonates born in our institution and referred from other institutions.
they are followed up till 2 months post discharge |
|
| ExclusionCriteria |
| Details |
pre term neonates who have not done KMC since birth. congenital heart disease, severe congenital anomaly |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| changes in weight gain and lipid profile |
changes in weight gain and lipid profile |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| infection rate and readmission rate |
at discharge and 2 months post discharge |
|
|
Target Sample Size
|
Total Sample Size="400"
Sample Size from India="400"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
04/05/2024 |
| 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="0"
Months="6"
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
|
Coconut oil is a medium chain triglyceride rich oil. Can penetrate through intact skin in preterm neonate and probably can change the lipid profile of the same. This may result in better weight gain. Kangaroo mother care, a essential intervention for pre term neonates since birth till 60 days post discharge is a known intervention which can help in better weight gain. Coconut oil application along with kangaroo mother care may cause further changes in weight gain and is a researchable issue. Here we are trying to compare lipid profile change, weight gain, infection rate, re admission rate of preterm neonates who have received coconut oil skin application along with kangaroo mother care since birth to 2 months post discharge to the group who receives only kangaroo mother care. |