| CTRI Number |
CTRI/2016/11/007493 [Registered on: 25/11/2016] Trial Registered Prospectively |
| Last Modified On: |
24/11/2016 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Other |
|
Public Title of Study
|
A trial to promote breast milk donation among eligible mothers and to optimize its utilization in a newborn unit |
|
Scientific Title of Study
|
Bundle of interventions to promote breast milk donation among eligible mothers and to optimize its utilization in a tertiary care extra mural new-born unit - A Quasi EXperimental study |
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrSwapnaL |
| Designation |
DM fellow |
| Affiliation |
Department of Neonatology, Institute of Child Health , Egmore,Madras Medical College |
| Address |
Department of Neonatology, Institute of Child Health, Madras Medical College, Egmore,Chennai -8
new no: 18, old no: 75 A, Kumaran Nagar, II Main Road, Chennai -82.
Chennai
TAMIL NADU
600008
India |
| Phone |
9884550083 |
| Fax |
|
| Email |
drswapnalingaldinna@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mangala BharathiS |
| Designation |
Associate Professor of Neonatology |
| Affiliation |
Department of Neonatology, Institute of Child Health, Egmore, Madras Medical College |
| Address |
Department of Neonatology
Institute of Child Health, Madras Medical College, Egmore,Chennai -8
Chennai
TAMIL NADU
600008
India |
| Phone |
9840786836 |
| Fax |
|
| Email |
drmangalabharathi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mangala BharathiS |
| Designation |
Associate Professor of Neonatology |
| Affiliation |
Department of Neonatology, Institute of Child Health, Egmore, Madras Medical College |
| Address |
Department of Neonatology
Institute of Child Health, Madras Medical College, Egmore,Chennai -8
Chennai
TAMIL NADU
600008
India |
| Phone |
9840786836 |
| Fax |
|
| Email |
drmangalabharathi@gmail.com |
|
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Source of Monetary or Material Support
|
|
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Primary Sponsor
|
| Name |
Institute of child health and Hospital Egmore |
| Address |
Halls Road , Egmore, Chennai-600008 |
| Type of Sponsor |
Government medical college |
|
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Details of Secondary Sponsor
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Swapna L |
Institute of child Health and Hospital , Department of Neonatology ,Egmore |
Halls Road , Egmore, Chennai-600008
Chennai
TAMIL NADU |
9884550083
drswapnalingaldinna@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Madras Medical College |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
breast milk donation |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Verbal counselling for mothers on breast milk donation |
Mothers whose babies got admitted to newborn unit will be given verbal counselling on breast milk donation |
| Intervention |
Verbal counselling on breast milk donation, video counselling on breast feeding and breast milk donation,my breast milk diary,relaxation music , breast massage prior to expression, ICDS supplementary nutrition, prescription based distribution of donor milk
, breast massage prior |
bundle components will be introduced to mothers whose babies got admitted to the newborn unit |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
44.00 Year(s) |
| Gender |
Female |
| Details |
1. Mothers who produce milk when their babies are prescribed nil per oral (for medical reasons). 2. Mothers in new born unit who can express breast milk more than their baby’s needs. 3.Mothers whose babies are on direct breast feeds are eligible for donation if they could produce excess milk without compromising the nutritional needs of the baby - Mothers whose babies show adequate weight gain (in term babies 20 grams/day and in preterm babies 15 gm/kg/day) and produce excess milk are eligible]. If the baby does not show adequate weight gain then the adequacy of breast milk intake will be assessed by measuring test weight before and after feeding the baby, and if it is appropriate as per the daily requirement of the baby, then the mother is eligible for donation. |
|
| ExclusionCriteria |
| Details |
Those mothers who did not give consent for the study |
|
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
| To study the proportion of eligible mothers donating minimum of 100 ml of breast milk per day to human milk bank before and after implementation of the bundle |
Daily |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| 1.Number of human milk donors per day before and after the implementation of bundle. 2. Number of donations per eligible mother per day before and after implementation of bundle 3. The percentage achievement of feeding requirement of newborn unit before and after implementation of bundle. |
Daily |
|
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Target Sample Size
|
Total Sample Size="662"
Sample Size from India="662"
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)
|
01/12/2016 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
Breast feeding is the best method of infant feeding. According to WHO, if mothers Own milk is unavailable or insufficient , the next best option is to use pasteurized donor human milk . In India, where the incidence of preterm and low birth weight is high, there is a need for donor human milk for babies whose mothers don’t produce enough milk. In extra mural unit like Institute of child health, Egmore, where sick babies get admitted there is lot of stress among mothers , so there is a need for increasing the milk output and motivating the concept of donation. From the review of literature it is evident that recruitement of donors to the milk bank should be continuous process and various strategies have to be undertaken to recruit new donors. It is also evident that the main motivating factor for breast milk donation is excess milk, altruistic feelings and motivation by health professional . Some simple individual measures like frequent expression of milk from the breast, breast massage prior to expression and relaxation music have been found to Increase breast milk volume .Breast feeding support and motivation by health professional has been associated with human milk donation.But studies have not been done implementing all these measures as a bundle to increase breast milk donation. So, this study is being undertaken to increase breast milk donation among eligible mothers by implementing the bundle of interventions and to optimize utilization of collected donor milk by implementing prescription based distribution of donor milk. |