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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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 growthNewborn 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.  


 
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