| CTRI Number |
CTRI/2022/01/039207 [Registered on: 06/01/2022] Trial Registered Prospectively |
| Last Modified On: |
05/01/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To compare Pulsed electric field processing(new method) of human milk with Holders pasteurisation(standard method) |
|
Scientific Title of Study
|
Effect of Pulsed electric field processing versus Holders pasteurisation, on human milk: A prospective observational study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SAISHREE PRADHAN |
| Designation |
DM Neonatology resident |
| Affiliation |
ICH & HC, Madras Medical College |
| Address |
No-83/34, seeyali street, Pudupet
Department of Neonatology
Institute of Child Health and hospital for children
Egmore
Chennai
Chennai
TAMIL NADU
600002
India |
| Phone |
09790402604 |
| Fax |
|
| Email |
saishree.p@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
KAMALRATHNAM C N |
| Designation |
Head of Department, Dept. of Neonatology |
| Affiliation |
ICH & HC, Madras Medical College |
| Address |
Department of Neonatology
A Block First Floor
ICH & HC
Egmore
Chennai
Department of Neonatology
Institute of Child Health and hospital for children
Egmore
Chennai
Chennai
TAMIL NADU
600008
India |
| Phone |
09790789376 |
| Fax |
|
| Email |
drkamal.rathnam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SAISHREE PRADHAN |
| Designation |
DM Neonatology resident |
| Affiliation |
ICH & HC, Madras Medical College |
| Address |
No-83/34, seeyali street, Pudupet
Department of Neonatology
Institute of Child Health and hospital for children
Egmore
Chennai
TAMIL NADU
600002
India |
| Phone |
09790402604 |
| Fax |
|
| Email |
saishree.p@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Child Health and Hospital for children, Madras Medical College, Chennai |
|
|
Primary Sponsor
|
| Name |
Institute of Child Health and Hospital for Children |
| Address |
Egmore
Chennai
600008 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Dr Saishree Pradhan |
Institute of child health and hospital for children |
A Block, First Floor, Human Milk Bank
Department of Neonatology
Egmore, Chennai
Chennai
TAMIL NADU |
09790402604
saishree.p@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institute ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Lactating mothers milk |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Holders pasteurisation |
62®C for 30 mins |
| Intervention |
Pulsed electric field (PEF) |
30KV, 600 pulses |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Pooled human donor milk of lactating mothers of term and preterm newborn at the human milk bank of Department of Neonatology , ICH, Egmore |
|
| ExclusionCriteria |
| Details |
1. Mother not willing to take part in the study
2. Mother with evidence of mastitis and local infection of breast.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the bacteriological and IgA profile in PEF treated and Holders pasteurized human milk |
At Baseline(raw milk)
after Holders pasteurisation and after PEF treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the major macronutrients in PEF treated and Holders pasteurized milk |
At Baseline(raw milk)
after Holders pasteurisation and after PEF treatment |
|
|
Target Sample Size
|
Total Sample Size="6"
Sample Size from India="6"
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)
|
10/01/2022 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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)?
Response - NO
|
|
Brief Summary
|
The best characterized and commonly used method of human milk preservation is holder pasteurization. However, the knowledge about the significant negative impacts of this method on the active components in human milk results in the development of novel techniques that could better preserve nutritional and non-nutritional factors. This study compares Pulsed electric field (PEF) method with Holders pasteurisation of the human milk. To analyze the bacteriological and immunological effect of pulsed electric field on human milk and compare it with holders pasteurization. To compare the major macronutrients in PEF treated and Holders pasteurized milk |