| CTRI Number |
CTRI/2025/03/081671 [Registered on: 05/03/2025] Trial Registered Prospectively |
| Last Modified On: |
23/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Process of Care Changes |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
Effect of thrice a day vs once a day coconut oil application on weight gain and hospital acquired infection in preterm very low birthweight newborns
A Randomised Control Trial
|
|
Scientific Title of Study
|
Effect of thrice a day vs once a day coconut oil application on growth parameters and nosocomial infection in preterm very low birthweight newborns A Randomised Control 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 |
Shonit kumar Patro |
| Designation |
DM Resident |
| Affiliation |
IMS and SUM hospital |
| Address |
Department of Neonatology, IMS and SUM hospital
Khordha
ORISSA
751003
India |
| Phone |
9439520051 |
| Fax |
|
| Email |
kumarshonit@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Debasish Nanda |
| Designation |
Professor |
| Affiliation |
IMS and SUM hospital |
| Address |
Deptt. of Neonatology, IMS and SUM hospital Ghatikia
Khordha
ORISSA
751003
India |
| Phone |
9861422685 |
| Fax |
|
| Email |
debasishnanda@soa.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Debasish Nanda |
| Designation |
Professor |
| Affiliation |
IMS and SUM hospital |
| Address |
Deptt. of Neonatology, IMS and SUM hospital Ghatikia
ORISSA
751003
India |
| Phone |
9861422685 |
| Fax |
|
| Email |
debasishnanda@soa.ac.in |
|
|
Source of Monetary or Material Support
|
| Shonit kumar patro
Department of neonatology,IMS and SUM hospital, Ghatikia, Bhubaneswar
Odisha,India
751003 |
|
|
Primary Sponsor
|
| Name |
Shonit Kumar Patro |
| Address |
Department of Neonatology, IMS and SUM hospital |
| 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 |
| Shonit kumar patro |
IMS and SUM hospital |
Department of Neonatology
Khordha
ORISSA |
9439520051
kumarshonit@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R00-R99||Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Once a day whole body oil massage |
4 weeks |
| Intervention |
Thrice a day whole body oil massage to the neonate |
4 weeks |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
30.00 Day(s) |
| Gender |
Both |
| Details |
G.A less than 33 weeks and/or less than 1500 grams born in IMS and SUM hospital |
|
| ExclusionCriteria |
| Details |
Sick baby
Presence of a major congenital anomaly;
Any Major surgical procedure
The mother had known immunodeficiency. |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
determine whether babies in the oil massage group (thrice a day) have better growth parameters than babies without oil massage (once a day)
|
determine whether babies in the oil massage group (thrice a day) have better growth parameters than babies
without oil massage (once a day) at 4 weeks PNA |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| • To determine whether thrice daily application of coconut oil at first month of life significantly reduced incidence of nosocomial infection of preterm infants |
4 weeks of post natal age |
|
|
Target Sample Size
|
Total Sample Size="184"
Sample Size from India="184"
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)
|
15/03/2025 |
| 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="6"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - None of the above
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [kumarshonit@gmail.com].
- For how long will this data be available start date provided 31-01-2026 and end date provided 31-01-2027?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
the skin of preterm very low birth weight babies lacks vernix and its antimicrobial properties and as the more premature the babies are the more immature the skin barrier. This leads to increased Transepidermal water loss leading to significant weight loss in premature babies. Emollients like coconut oil, petroleum jelly,topical dressings decrease TEWL and form mechanical barrier to bacteria . Coconut oil is used traditionally in India for Indian massage. Presently there are very few studies evaluating the efficacy of coconut oil on growth of preterm infants. |