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CTRI Number  CTRI/2024/07/070523 [Registered on: 12/07/2024] Trial Registered Prospectively
Last Modified On: 03/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A study on factors influencing the practice of exclusive breastfeeding and effect of Exclusive breastfeeding on respiratory and gastrointestinal infections in children under 3 years of age 
Scientific Title of Study   Factors influencing the practice of exclusive breastfeeding and effect of Exclusive breastfeeding on respiratory and gastrointestinal infections in children under 3 years of age in Tiruvallur district-A community based cross-sectional study 
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 J Reena 
Designation  Postgraduate Scholar 
Affiliation  National Institute of Siddha 
Address  Room no 16/17, Department of Kuzhandhai Maruthuvam, National Institute of Siddha, Tambaram Sanatorium, Chennai

Kancheepuram
TAMIL NADU
600047
India 
Phone  9944381097  
Fax    
Email  reenajayaraman@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr M Meenakshi Sundaram 
Designation  Professor and Head of the Department 
Affiliation  National Institute of Siddha 
Address  Room no 16/17, Department of Kuzhandhai Maruthuvam, National Institute of Siddha, Tambaram Sanatorium, Chennai

Kancheepuram
TAMIL NADU
600047
India 
Phone  9444214582  
Fax    
Email  mmssiddha@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr M Meenakshi Sundaram 
Designation  Professor and Head of the Department 
Affiliation  National Institute of Siddha 
Address  Room no 16/17, Department of Kuzhandhai Maruthuvam, National Institute of Siddha, Tambaram Sanatorium, Chennai

Kancheepuram
TAMIL NADU
600047
India 
Phone  9444214582  
Fax    
Email  mmssiddha@rediffmail.com  
 
Source of Monetary or Material Support  
National Institute of Siddha,Tamabaram Sanatorium,Chennai-47 
 
Primary Sponsor  
Name  National Institute of Siddha 
Address  Room no 16/17, Department of Kuzhandhai Maruthuvam, National Institute of Siddha, Tambaram Sanatorium, Chennai-600047 
Type of Sponsor  Research institution and hospital 
 
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 J Reena  Integrated Child Development Services centre  Integrated Child Development Services centres Tiruvallur district
Thiruvallur
TAMIL NADU 
9944381097

reenajayaraman@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Department of Integrated Child Development Services  No Objection Certificate 
Institutional Ethics Committee National Institute of Siddha  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Lactating and non lactating mothers 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  6.00 Month(s)
Age To  3.00 Year(s)
Gender  Both 
Details  1.Children aged between 6 months to 3 years of age 
 
ExclusionCriteria 
Details  1.Children with dysmorphic features
2.Children with any syndrome
3.Children with congenital heart disease
4.Mothers who had contraindications for breastfeeding 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.The various factors affecting exclusive breastfeeding will be ruled out and the effect of breastfeeding on respiratory and gastrointestinal infections will be studied and analysed.
2.Also various patterns of practices followed in Tiruvallur district during respiratory and gastrointestinal infections in children will be studied
3.Understanding the intricate web of factors associated with EBF practice in the Tiruvallur district will help to plan various approaches to overcome lactation problems using principles of siddha system of medicine in future.  
Data collection-4 months
Data analysis-1 month
Data submission and publication in journal- 1 month 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="350"
Sample Size from India="350" 
Final Enrollment numbers achieved (Total)= "350"
Final Enrollment numbers achieved (India)="350" 
Phase of Trial   N/A 
Date of First Enrollment (India)   22/07/2024 
Date of Study Completion (India) 22/10/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

BACKGROUND:

Breast milk is the most appropriate and ideal food for the infant. The baby does not require any food other than breast milk until 6 months of age. The data suggest that infant mortality rates in the developing countries are 5–10 times higher among children who have not been breastfed or who have been breastfed for less than 6 months. Breastmilk contains antimicrobial factors such as macrophages, lymphocytes, secretory IgA, antistreptococcal factor, lysozyme, and lactoferrin, which provide considerable protection not only against diarrheal diseases and necrotizing enterocolitis but also against respiratory infections in the first month of life.

In other words, breast milk contains other proteins whose functions are not nutritive but anti-infective e.g., IgG, lysozyme, and living cells. In the intestine, lactose helps the “right” kind of bacteria (i.e., Lactobacillus bifidus) to grow. Lactobacillus and lactose helps to keep the intestinal content acidic, which inhibits the growth of harmful bacteria. Colostrum is the milk immediately delivered after birth. It is rich in proteins, vitamins A and K, and immunoglobulins (IgA). IgA acts as an intestinal antiseptic and anti-infective. It protects the child against respiratory and alimentary diseases and also against allergic bronchitis, asthma, etc. It is the first natural vaccine the child receives from the mother. Breastfeeding is a “lifeline” for newborn babies and should be started immediately after birth. Although breastfeeding is a nearly universal practice in India, very few children are put on breastfeeding immediately after delivery. National Family Health Survey (NFHS-5) (2019–2021) data provide cardinal information on breastfeeding practices in Tamil Nadu. About 60.2% of children <3 years breastfed <1 h, 55.1% of newborn <6 months had exclusive breastfeeding (EBF), and 66.5% of children 6–8 months received a solid/semisolid diet and breast milk.

The Introduction of supplementary foods before 6 months of age may put infants at risk of malnutrition because other liquids and solids are nutritiously inferior to breast milk. The consumption of liquids and solid smashed foods at an early age also increases children’s exposure to pathogens and consequently puts them at a greater risk of diarrhoea.. A systematic review and meta-analysis that summarized evidence from developed countries found that maternal employment, insufficient or lack of breast milk, associated maternal/infant morbidities, lactational difficulties, cultural norms, and maternal body image issues were the barriers associated with low practice of EBF up to 6 months of life. Lack of support from family or the absence of social support systems was also identified as one of the barriers for continuing EBF for 6 months. Further, cultural beliefs such as giving water along with feeds (believed to aid in digestion), influence the sub-optimal practice of EBF for 6 months .

A study carried out by Penugonda et al. showed that 185 (69 EBF + 116 non-EBF) of 450 infants reported a total of 242 illnesses, most commonly respiratory (86.6%) followed by gastrointestinal (11.6%). The number of illnesses per infant was 0.45 and 0.6 in EBF and non-EBF, respectively (P = 0.015). Illness incidences in EBF infants were significantly lower during all successive time intervals after 10 weeks of age. Logistic regression analysis confirmed significantly lower illness incidence in EBF infants at 10–14 weeks (OR: 0.27 [CI: 0.12–0.64]).

A study conducted in Kolkata showed that 82.22% of breastfed infants had no diarrhea, and the absence of RTI was observed in 69.81%. It was also noted that both episodes of diarrhea and RTI in infants become less when the duration of breastfeeding increases. The study also significantly (P < 0.001 and P = 0.03) revealed that the occurrence of diarrhea and RTI was found to have lower incidence in colostrum-fed babies. Out of 391 colostrum-fed babies, about 85.42% had no diarrhea, and the absence of RTI was noticed in 72.12%.

A study on the Global trends in exclusive breastfeeding by United Nations Fund for Population Activities (UNFPA) reveals that although considerable improvements have been made in some regions of the world, the prevalence of exclusive breastfeeding remains far too low in many areas of the developing world.

Though the Exclusive breastfeeding rate in Tiruvallur district is 65.5% (urban area-76% and in rural area-55%) ,this is far below the widely accepted “universal coverage” target of 90% coverage and so there is a need to rule out the factors affecting EBF in Tiruvallur district.

OBJECTIVE

Primary Objective:

 To rule out various factors affecting exclusive breastfeeding practices.

Secondary objective:

To assess the effect of  exclusive breastfeeding on  respiratory and gastrointestinal infections in children under 3 years of age and to assess the pattern of practices over respiratory and gastrointestinal infections in children.

 STUDY DESIGN:

This is an observational study with a duration of 6 months which includes 350 mothers of children under 3 years of age in Tiruvallur district who will be included in the study by using simple random sampling method to whom a questionnaire regarding breastfeeding will be given and collected after explaining about the study and obtaining proper consent from the mothers. Mothers with children aged between 6 months to 3 years will be included and mothers with children who have congenital heart disease, any syndrome, dysmorphic features and mothers who had contraindication for breastfeeding will be excluded from this study.

 

      OUTCOME:

The various factors affecting exclusive breastfeeding will be ruled out and the effect of breastfeeding on respiratory and gastrointestinal infections will be studied and analysed. Also various patterns of practices followed in Tiruvallur district during respiratory and gastrointestinal infections in children will be studied. Understanding the intricate web of factors associated with EBF practice in the Tiruvallur district will help to plan various approaches to overcome lactation problems using principles of Siddha system of medicine in future.

RESULTS AND DISCUSSION:

The results will be statistically analysed and reported.

KEYWORDS:

Exclusive breastfeeding, Tiruvallur district, respiratory infections, gastrointestinal infections


 
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