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CTRI Number  CTRI/2026/03/106155 [Registered on: 13/03/2026] Trial Registered Prospectively
Last Modified On: 12/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Oil application on skin]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To study the effect of oil application on weight loss in preterm neonates during first 10 days of life 
Scientific Title of Study   Open label Randomized Controlled Trial Comparing postnatal Weight Loss in Preterm Neonates (28-33+6 weeks ) With and Without Topical Coconut Oil Application During the First 10 Days of Life 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kasula Prathyush Reddy 
Designation  DM, Senior Resident  
Affiliation  Bharati Vidyapeeth (Deemed to be University) Medical College, Pune  
Address  NICU, Second floor, Bharati Hospital, Dhankawadi, Pune

Pune
MAHARASHTRA
411043
India 
Phone  9640705045  
Fax    
Email  prathyushkasula@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Nandini Malshe  
Designation  Professor and Head of the Department  
Affiliation  Bharati Vidyapeeth (Deemed to be University) Medical College, Pune  
Address  NICU, Second floor, Bharati Hospital, Dhankawadi, Pune

Pune
MAHARASHTRA
411043
India 
Phone  9822850716  
Fax    
Email  malshenandini@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Kasula Prathyush Reddy 
Designation  Senior Resident  
Affiliation  Bharati Vidyapeeth (Deemed to be University) Medical College, Pune  
Address  NICU, Second floor, Bharati Hospital, Dhankawadi, Pune

Pune
MAHARASHTRA
411043
India 
Phone  9640705045  
Fax    
Email  prathyushkasula@gmail.com  
 
Source of Monetary or Material Support  
Bharati Vidyapeeth (Deemed to be University) Medical College, Pune 411043 
 
Primary Sponsor  
Name  Bharati Vidyapeeth (Deemed to be University) Medical College, Pune 
Address  Bharati Vidyapeeth (Deemed to be University) Medical College, Pune 411043 
Type of Sponsor  Private medical college 
 
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 
Dr Kasula Prathyush Reddy  Bharati Hospital, Pune  Department of Neonatology, Division of ICU, Room NICU, Second floor, Pune, Maharastra
Pune
MAHARASHTRA 		 9640705045

prathyushkasula@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTE, BHARATI VIDYAPEETH (DEEMED TO BE UNIVERSITY) MEDICAL COLLEGE, PUNE 411043   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Topical coconut oil application  Parachute coconut oil will be applied once a day 2 ml/kg will be taken and will be applied over baby without massage from face below without scalp after sponging  
Comparator Agent  Topical coconut oil application  Parachute coconut oil will be applied once a day 2ml/kg will be taken and applied over baby without massage from face below without scalp after sponging  
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  10.00 Day(s)
Gender  Both 
Details  All neonates between 28 to 33 weeks 6 days of gestational age , admitted at less than or at 6 Hour of life
 
 
ExclusionCriteria 
Details  Major life- threatening congenital malformations, major chromosomal anomalies
Contraindication to massage like dislocations, fractures.
Fetal hydrops
Congenital diseases of skin associated with skin breach or denudation of skin precluding oil application
Neonates with pre-existing skin infection.
Parents who refuse to give consent
 
 
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 determine the difference in the mean gram weight loss during the first 10 days of life between the coconut oil application group and the no oil application group in preterm neonates 28-33+6 weeks gestational age
 		 To determine the difference in the mean gram weight loss during the first 10 days of life between the coconut oil application group and the no oil application group in preterm neonates 28-33+6 weeks gestational age
 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the rate of weight gain after day 10 of life between coconut oil and non- oil application group till discharge

To assess skin-related adverse effects (e.g., erythema, infection, peeling) associated with coconut oil use.

To compare episodes of sepsis between coconut oil and non- oil application group.

To determine the episodes of hypothermia between coconut oil and non- oil application group.
 		 at day of life 10 and at discharge  
 
Target Sample Size   Total Sample Size="124"
Sample Size from India="124" 
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 2/ Phase 3 
Date of First Enrollment (India)   01/05/2026 
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 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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [prathyushkasula@gmail.com].

  6. For how long will this data be available start date provided 01-05-2026 and end date provided 31-10-2027?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   The primary objective is to To determine the difference in the mean gram weight loss  during the first 10 days of life between the coconut oil application group and the no oil application group in preterm neonates 28-33+6 weeks gestational age.
In this study, Parachute coconut oil will be applied once a day 2 ml/kg will be  taken and will be applied over baby without massage from face below without scalp after sponging.
Baby will receive oil application from admission within 6 hours till discharge.
A low budget study that can significantly impact the weight loss trend in VLBW newborns and hence will be very useful to reduce morbidity and , mortality in low income countries and SNCU’s of rural and sub-urban settings.
A 
 
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