| CTRI Number |
CTRI/2025/04/084211 [Registered on: 07/04/2025] Trial Registered Prospectively |
| Last Modified On: |
05/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Oil massage of preterm neonate] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Coconut oil massage versus Sunflower oil massage on the weight gain velocity in preterm neonate - A Randomized controlled trial |
|
Scientific Title of Study
|
Effect of Coconut oil massage versus Sunflower oil massage on the weight gain velocity in preterm neonate - 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 |
Souradip Banik |
| Designation |
DM Neonatology Resident |
| Affiliation |
National Institute of Medical Sciences and Research , Jaipur, Rajasthan |
| Address |
First floor, Department of Neonatology, near Neonatal Intensive care unit , National Institute of Medical Sciences and Research ,
Jaipur , Rajasthan , India
Pin- 303121
Jaipur
RAJASTHAN
303121
India |
| Phone |
8794168494 |
| Fax |
|
| Email |
baniksouradip@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Gun jana Kumar |
| Designation |
Associate professor |
| Affiliation |
National Institute of Medical Sciences and Research , Jaipur, Rajasthan |
| Address |
First floor, Department of Neonatology, near Neonatal Intensive care unit , National Institute of Medical Sciences and Research ,
Jaipur , Rajasthan , India
Pin- 303121
Jaipur
RAJASTHAN
303121
India |
| Phone |
7073077130 |
| Fax |
|
| Email |
gunjanakumar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Gunjana Kumar |
| Designation |
Associate professor |
| Affiliation |
National Institute of Medical Sciences and Research , Jaipur, Rajasthan |
| Address |
First floor, Department of Neonatology, near Neonatal Intensive care unit , National Institute of Medical Sciences and Research ,
Jaipur , Rajasthan , India
Pin- 303121
Jaipur
RAJASTHAN
303121
India |
| Phone |
7073077130 |
| Fax |
|
| Email |
gunjanakumar@gmail.com |
|
|
Source of Monetary or Material Support
|
| NATIONAL INSTITUTE OF MEDICAL SCIENCES AND RESEARCH, NIMS UNIVERSITY,JAIPUR,RAJASTHAN |
|
|
Primary Sponsor
|
| Name |
Department of Neonatology |
| Address |
First floor , Department of Neonatology, near Neonatal Intensive care unit , National Institute of Medical Science, NIMS University, Jaipur, Rajasthan |
| 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 |
| Gunjana Kumar |
NIMS NEONATAL INTENSIVE CARE UNIT |
First floor , Neonatal intensive care unit, national institute of medical sciences, NIMS University, Jaipur, Rajasthan
303121
Jaipur
RAJASTHAN |
7073077130
gunjanakumar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, NIMS University,Jaipur, Rajasthan |
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 |
| Intervention |
Coconut oil massage |
Thrice daily massage for 28 days |
| Comparator Agent |
Sunflower oil massage |
Thrice daily massage for 28 days |
|
|
Inclusion Criteria
|
| Age From |
3.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
All hemodynamically stable neonates between 28 weeks to 34+6 weeks of gestation will be enrolled at 72 hours of birth |
|
| ExclusionCriteria |
| Details |
Babies with major congenital malformation
Refusal to give consent
Generalised skin disorders and local skin burns
Ecchymosis m soft tissue injury or bleeding tendencies
Hydrops
Mechanical ventilation with map more than 7 or High Frequency ventilation
Presence of fracture
IVH grade 2 or more at enrolment
Hemodynamically unstable with more than 2 inotropes
Intercostal tube drainage in situ at enrolment |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effect of coconut oil massage on weekly weight gain velocity and cumulative weight gain over four weeks with that of Sunflower oil in preterm neonates |
28 days of life or death |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Biochemical parameters
1. Biochemical parameters of bone health ( calcium , Phosphorus,Alkaline phosphatase, Tubular re absorption of phosphate, Parathyroid hormones , Triglycerides, vitamin D levels)
2.Total serum bilirubin ( maximum value)
3. Insulin like growth factor 1 levels
Non biochemical parameters
1. Length gain velocity
2.Head circumference gain velocity
3 IVH GRADE 2 or more
4. Probable or proven sepsis
Neonatal mortality |
28 days of life or death |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
17/04/2025 |
| 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
|
Newborn oil massage is a traditional practice that acts by protecting skin barrier functions, thereby reducing trans epidermal water losses and conserving energy to promote overall growth. Topical emollient therapy with coconut oil or sunflower oil is safe and effective in reducing skin trauma in preterm infants. Evidence of in facility weight gain with oil massage therapy with the specific type of emollient in extreme and very preterm , extremely low birth weight and very low birth weight babies is deficient. Coconut and sunflower oil both being easily available with minimum cost constraints are planned to compare so as to assess their effect on the weight gain velocity in the two groups of neonates. These two are only chosen as they both are comparable in terms of cost with its ease of availability especially in LMIC. Moreover, sunflower oil is known for its high content of mono and polyunsaturated fatty acid, particularly omega 6 fatty acids. It is also rich in vitamin A,E,D,C which are essential antioxidants. Whereas, coconut oil is rich in saturated fatty acid content. |