| CTRI Number |
CTRI/2020/05/025256 [Registered on: 20/05/2020] Trial Registered Prospectively |
| Last Modified On: |
05/05/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Nursing] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of coconut oil versus petroleum jelly on prevention on diaper rash |
|
Scientific Title of Study
|
A Randomized Controlled Trial to Compare the Effectiveness of the Topical Application of Coconut oil versus Vaseline Petroleum Jelly for prevention of Diaper Dermatitis among neonates admitted in selected Newborn units of Nehru Hospital, PGIMER, Chandigarh, 2019-2021 |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Amandeep Kaur Walia |
| Designation |
M.Sc. Nursing student |
| Affiliation |
National Institute of Nursing Education |
| Address |
Room no.208,National Institute of Nursing Education, Post Graduate Institute of Medical Education and Research, Sector 12 , Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7888396370 |
| Fax |
|
| Email |
amandeepsaini.1987@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
V Venkadalakshmi |
| Designation |
Lecturer |
| Affiliation |
National Institute of Nursing Education |
| Address |
Room no.319,National Institute of Nursing Education, Post Graduate Institute of Medical Education and Research, Sector 12 , Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9855552533 |
| Fax |
|
| Email |
venkadalakshmi_v@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Amandeep Kaur Walia |
| Designation |
M.Sc. Nursing student |
| Affiliation |
National Institute of Nursing Education |
| Address |
Room no.208,National Institute of Nursing Education, Post Graduate Institute of Medical Education and Research, Sector 12 , Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7888396370 |
| Fax |
|
| Email |
amandeepsaini.1987@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Nursing Education,Postgraduate Institute of Medical Education and Research, Chandigarh |
|
|
Primary Sponsor
|
| Name |
National Institute of Nursing Education |
| Address |
Post Graduate Institute of Medical Education and Research,Chandigarh |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Post Graduate Institute of Medical Education and Research |
Post Graduate Institute of Medical Education and Research,Chandigarh |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Amandeep Kaur Walia |
Post Graduate Institute of Medical Education and Research |
Clean Labor Room Extension , Maternity ward,Obstetrics and Gynecology Department, Nehru Hospital,Post Graduate Institute of Medical Education and Research,Chandigarh
Chandigarh
CHANDIGARH |
7888396370
amandeepsaini.1987@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L22||Diaper dermatitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Application of coconut oil |
It is the application of coconut oil which contains saturated fatty acids, especially saturated fat. It will be applied for 10 minutes prior to application of new diaper among neonates admitted in selected newborn units of Nehru Hospital, PGIMER, Chandigarh. |
| Comparator Agent |
Application of petroleum jelly |
It is the application of Vaseline petroleum jelly. It will be applied for 10 minutes prior to application of new diaper among neonates admitted in selected newborn units of Nehru Hospital, PGIMER, Chandigarh. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
42.00 Day(s) |
| Gender |
Both |
| Details |
1. Gestational age more than or equal to 34 weeks
2. Hemodynamically stable
3.Willing for follow-up at 6 weeks in postnatal clinic
|
|
| ExclusionCriteria |
| Details |
1. Pre -existing diaper dermatitis at the time of enrollment
2. Any known congenital skin disease
3. Post perineal surgery patient
4. Parents not giving consent
5. Parents not willing to follow up in postnatal clinic for vaccination at 6 weeks of post-natal age
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Diaper dermatitis |
at 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Efficacy of topical coconut oil as compared with Vaseline for prevention of moderate to severe diaper dermatitis
Prevalence of diaper dermatitis among the enrolled infants
Compliance of both interventions. Compliance will be assessed using a preprinted check list. |
At 6 weeks |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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 1 |
|
Date of First Enrollment (India)
|
16/07/2020 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Diaper rash is frequently encountered problem in infancy. One of the important measures for prevention of diaper dermatitis is use of moisturizing agents like petroleum gel. In India, Coconut oil is commonly used for body massage as well as for moistening the perineal area. Although, it is considered to be useful for prevention of diaper dermatitis, but its efficacy is not tested for this entity. We aim to compare its efficacy with petroleum jelly (Vaseline) for prevention of diaper dermatitis in infants less than 6 months old. |