| CTRI Number |
CTRI/2022/12/048207 [Registered on: 16/12/2022] Trial Registered Prospectively |
| Last Modified On: |
13/10/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Role of Massage with Coconut Oil-based Emollient on Growth, Bone Strength and Development of Newborns |
|
Scientific Title of Study
|
Role of Massage with Virgin Coconut Oil-based Emollient on Growth, Bone Strength and Neurodevelopment of Newborns |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jonaki Pal |
| Designation |
Senior Resident |
| Affiliation |
Burdwan Medical College |
| Address |
SR Hostel, Burdwan Medical College, Burdwan
Barddhaman WEST BENGAL 713104 India |
| Phone |
|
| Fax |
|
| Email |
jonakipal@yahoo.com |
|
Details of Contact Person Scientific Query
|
| Name |
Kamirul Islam |
| Designation |
Consultant |
| Affiliation |
Katwa SDH |
| Address |
SNCU, 2nd Floor, Deptt of Pediatrics, Burdwan Medical College, Burdwan Department of Pediatrics (2nd Floor), Katwa SDH, Burdwan Barddhaman WEST BENGAL 713104 India |
| Phone |
8972360456 |
| Fax |
|
| Email |
kamirul.islam7@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Kamirul Islam |
| Designation |
Consultant |
| Affiliation |
Katwa SDH |
| Address |
SNCU, 2nd Floor, Deptt of Pediatrics, Burdwan Medical College, Burdwan Department of Pediatrics (2nd floor), Katwa SDH, Burdwan Barddhaman WEST BENGAL 713104 India |
| Phone |
8972360456 |
| Fax |
|
| Email |
kamirul.islam7@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Pediatrics, Burdwan Medical College |
|
|
Primary Sponsor
|
| Name |
Marico Limited |
| Address |
Grande Palladium, 7th floor, 175, CST Road, Kalina, Santacruz East, Mumbai, Maharashtra 400098 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 |
| Jonaki Pal |
SNCU & DEIC, 2nd floor, Department of Pediatrics, Burdwan Medical College |
Baburbag, Burdwan Barddhaman WEST BENGAL |
8017750670
jonakipal@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Burdwan Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Normal newborns |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Massage with virgin coconut oil-based emollient. |
Infants of intervention group will receive massage with coconut oil-based emollient as described by Kumar et al in newborn period (first 28 days of life) |
| Comparator Agent |
Only massage |
Infants of this group will receive only massage without any emollient application for in newborn period (first 28 days of life) |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
15.00 Day(s) |
| Gender |
Both |
| Details |
Parents/ legal guardians of all newborn discharged at an age of ≤15 days will be approached for inclusion in the study. |
|
| ExclusionCriteria |
| Details |
Major systemic illness
Refusal of consent
Planning to change residence
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Weight gain/day |
day 30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Anthropometric parameters |
Upto 6 months |
| Neonatal skin condition score |
Upto 30 days |
| Velocity of sound at upper end of tibia |
3rd and 6th month |
| Neurodevelopment |
6th month |
| Complications |
Upto 6th month |
|
|
Target Sample Size
|
Total Sample Size="342" Sample Size from India="342"
Final Enrollment numbers achieved (Total)= "171"
Final Enrollment numbers achieved (India)="171" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/12/2022 |
| Date of Study Completion (India) |
31/05/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0" Months="8" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Coconut oil supplementation is helpful in maturity of skin with additional anti-microbial effect. This study will be conducted to determine the efficacy of coconut oil massage in newborn on their growth, bone strength, neurodevelopment and brain growth. Newborn discharged from maternity ward or Sick Newborn Care Unit and aged ≤15 days will be included in this study. Exclusion criteria were major systemic illness, refusal of consent, and planning to change residence. Infants of group A will receive massage with coconut oil-based emollient as described by Kumar et al for three months. Newborns of group B receive only massage without any emollient application. Anthropometric parameters of all newborns will be measured fortnightly till 6 month. Skin condition of the newborn will be assessed at the time of recruitment,14th and 28th day. Sound velocity at the upper end of tibia will be measured at 3rd and 6th month (±7 days) by trained radiologist. Neurodevelopment will be assessed at 6th month by DASII scale. Collected data will be entered in Microsoft excel worksheet after double-checking. SPSS version 19.0 will be used for data-analysis. P<0.05 will be taken as statistically significant. Coconut oil massage might be helpful in reducing the neonatal and infant mortality in an economic way. |