| CTRI Number |
CTRI/2014/11/005199 [Registered on: 13/11/2014] Trial Registered Prospectively |
| Last Modified On: |
21/05/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
details mentioned in brief summary. |
| Study Design |
Other |
|
Public Title of Study
|
Study of milk composition from adequately nourished and undernourished mothers. |
|
Scientific Title of Study
|
An observational study to characterize human milk of mothers delivering term SGA and AGA infants |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| 12.23 NRC Protocol amended version 1.0 dated 16 Dec 2016 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
|
| Designation |
|
| Affiliation |
|
| Address |
|
| Phone |
|
| Fax |
|
| Email |
|
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Sonika Newar |
| Designation |
Medical Monitor |
| Affiliation |
JSS Medical Research India Limited |
| Address |
JSS Medical Research India Limited,
6th Floor, Vatika Mindscapes (Tower B) Plot 12/2, Sector 27D
Faridabad
HARYANA
121003
India |
| Phone |
91-8800799887 |
| Fax |
91-01296613520 |
| Email |
sonika.newar@jssresearch.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Shariq Anwar |
| Designation |
Head Operations |
| Affiliation |
JSS Medical Research India Limited |
| Address |
JSS Medical Research India Limited,
6th Floor, Vatika Mindscapes (Tower B) Plot 12/2, Sector 27D
Faridabad
HARYANA
121003
India |
| Phone |
91-9810979215 |
| Fax |
91-01296613520 |
| Email |
shariq.anwar@jssrsearch.com |
|
|
Source of Monetary or Material Support
|
| Nestec Ltd.
CH-1800 Vevey, Switzerland
|
|
|
Primary Sponsor
|
| Name |
Nestec Ltd |
| Address |
CH-1800 Vevey, Switzerland |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
Details of Secondary Sponsor
Modification(s)
|
| Name |
Address |
| JSS Medical Research India Limited |
6th Floor, Vatika Mindscapes (Tower B) Plot 12/2, Sector 27D
Faridabad-121003, Haryana,
India
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sarika Prasad |
Adhithya Adhikari Hospital, Mysore |
Contour Road, Gokulam, Pincode-570002
Mysore
KARNATAKA |
91-99020100668
Dr.sarikaprasad@gmail.com |
| Dr Nandini Malshe |
Bharati Hospital & Research Centre |
Main Building, Ground Floor Department of Pediatric & Neonatology Bharati Vidyapeeth Deemed University 4th floor, Pune-Satara Road, Dhankawadi Pune-411043 India
Pune
MAHARASHTRA |
919822850716
malshenandini@gmail.com |
| Dr Anil Kumar Sapare |
Mazumdar Shaw Medical Centre |
5th Floor, Mazumdar Shaw Medical Centre,
Department of Pediatrics,
Narayana Hrudayalaya Private Limited, #258/A, Bommasandra Industrial Area, Hosur Road, Bangalore-560099, India
Bangalore
KARNATAKA |
91-8071222360
aksapare@hotmail.com |
| Dr Neelam Kler |
Sir Ganga Ram Hospital |
F-36
Department of Neonatology,
Institute of Child & Health
Sir Ganga Ram Hospital Marg,
Old Rajinder Nagar, New Delhi-110060, India
Central
DELHI |
91-9811047391
drneelamkler@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Adhithya Adhikari Hospital-Institutional Ethics Committee |
Approved |
| Bharati vidyapeeth deemed university Institutional ethics committee office, 4th floor, Bharati hospital & research centre,Pune-satara road,Dhankawadi,Pune-411043 |
Approved |
| Ethics Committee, Sir Ganga Ram Hospital Ethics Committee, Room No 1496. IV Floor , Old Building ,Sir Ganga Ram Hospital , Old Rajinder Nagar, New Delhi-110060 |
Approved |
| Narayana Hrudayalaya Medical Ethics Committee (NHMEC), NH Health City, No.258/A, Bomasandra Industrial Area, AnakalTaluk, Bangalore-560099, Karnataka |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E440||Moderate protein-calorie malnutrition, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Not Applicable as this is an observational study |
Not Applicable as this is an observational study |
| Comparator Agent |
Not Applicable. |
Not Applicable. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1. All mothers who delivered term infants, either SGA or AGA
2. Mothers between 18 and 40 years of age inclusive, at the time of enrolment
3. Having decided to predominantly breast-feed their new born baby at least until 6 months of age
4. Having permanent residence at a maximum distance of 50km from the hospital/center of investigation for the duration of this study and being able to follow all the steps of this study
5. Willing to provide informed consent according to the requirements of local regulations.
|
|
| ExclusionCriteria |
| Details |
1. Preterm delivery (≤ 36 weeks + 6 days completed) of gestational age)
2. Currently participating or having participated in an interventional clinical trial during the last 4 weeks prior to the beginning of this study
3. Having a BMI ≥ 25.0
4. Chewing tobacco, smoking or drinking alcohol (> 1 glass per day), consuming illicit drugs during pregnancy or/and duration of the study
5. Presenting any disease or medical condition which might prevent breast-feeding or collecting the human milk samples or for which breast-feeding is contraindicated
6. Having diabetes or gestational diabetes mellitus
7. Presenting dietary problems/illnesses such as anorexia, bulimia and celiac disease
8. Subject unable to comply with study procedures or unable to come to hospital for the study visits.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
1. Milk samples will be collected longitudinally from the mothers will be enrolled for the characterization by modern analytical and state-of-the-art techniques.
2. Analyses of functional milk components, such as macronutrients (total fat, total protein, total lactose, total energy and total solid, crude proteins) and total protein analysis by BCA kit is planned. |
Throughout the study period. |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
1. Dietary intake will be assessed by a dietary questionnaire and analyzed by tool/books.
Example-By use of “Nutritive Value of Indian Foods†or a similar book/tool issued by National Institute of Nutrition
|
Throughout the study period. |
| 2. The maternal milk composition will be correlated longitudinally to mother’s diet, stage of lactation, type of delivery, sex of the infant, single/multiple birth, infant anthropometric measures (weight, length and head circumference), gestational age at birth and birth anthropometrics |
Throughout the study period. |
| 3. Other parameters & functional milk components are considered as exploratory. Inclusion of these & other possible exploratory parameters will be assessed periodically or at end of study based on development of these analytical methodologies in India . |
Throughout the study period. |
|
Target Sample Size
Modification(s)
|
Total Sample Size="142"
Sample Size from India="142"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="142" |
|
Phase of Trial
|
Phase 4 |
Date of First Enrollment (India)
Modification(s)
|
10/04/2015 |
| Date of Study Completion (India) |
06/04/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="2"
Months="11"
Days="6" |
Recruitment Status of Trial (Global)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This
is an observational study to characterize human milk of mothers delivering term
SGA and term AGA infants. This is an observational, exploratory, longitudinal
(from birth to 6 months postpartum), 4 parallel groups, and multi-centric
study. Total of max 260 subjects will be randomized in the study assuming 20% dropout rate. The recruitment period for the study in India is for 6 months. The Primary Objective of the study is to characterize and quantify maternal milk composition from mothers of adequately nourished and under nourished status delivering term Small for Gestational Age (SGA) infants, compared to adequately-nourished and undernourished mothers delivering term Appropriate for Gestational Age (AGA) infants as defined in Intergrowth-21st Newborn Size Chart The secondary objective of the study is- 1. Association of maternal milk components with dietary intake and nourishment status of the mother. 2. Associations of maternal and infant clinical parameters to maternal milk nutrients. To explore and analyze additional functional milk components, such as triacylglycerol, cholesterols, carotenoids, vitamins, microbiota, peptide profile, microRNA, cytokines, growth factors and hormones.
The subject will enroll in the study after signing the Informed Consent Form after delivery the infants (i.e. term AGA & term SGA) within 72 hours. Total Duration of the study for subject is 24 weeks. Sponsor will notify the end of study after 90 days of last subject last visit. Principal Investigator responsibility is to detect and document AE and SAE. Reference:
1.
Agostoni C. Small-for-gestational-age infants need
dietary quality more than quantity for their development: the role of human
milk. Acta Paediatr. 2005 Jul;94(7):827-9. 2. Barker DJP, Winter PD, Osmond C, Margetts B, Simmonds SJ. Weight in infancy and death from ischemic heart disease. Lancet 1989;2:577–80.
|
3. Barker DJP, Hales CN, Fall CHD, Osmond C, Phipps
K, Clark PMS. Type 2 (non-insulin-dependent) diabetes mellitus, hypertension
and hyperlipidemia (syndrome X): relation to fetal growth. Diabetologia
1993;36:62–7. 4. Figueras F, Oros D, Cruz-Martinez R, Padilla N,
Hernandez-Andrade E, Botet F, Costas-Moragas C, Gratacos E. Neurobehavior in
term, small-for-gestational age infants with normal placental function.
Pediatrics. 2009 Nov;124(5):e934-41. doi: 10.1542/peds.2008-3346. 5. Karlberg J, Albertsson-Wikland K. Growth in
full-term small-forgestational-age infants: from birth to final length.
Pediatr Res 1995;38:733–9. 6. Lee AC, Katz J, Blencowe H, et al. for the CHERG
SGA-Preterm Birth Working Group. National and regional estimates of term and
preterm babies born small for gestational age in 138 low-income and
middle-income countries in 2010. Lancet Glob Health 2013; 1: e26-e36.
|
|
|
|