Effect of Breastfeeding Optimization on Early Vascular Development

Study Overview
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Brief Summary
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This study aims to find out whether breast feeding optimization will increase breast feeding rates and to evaluate its effect on cardiovascular risk and general health of children.

Detailed Description
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Breast feeding is suggested to give many benefits for babies and there are some initial prove that it might affect their future health, including the development of cardiovascular diseases. In Indonesia, breast feeding rates are very low, while there is a strong upsurge of cardiovascular disease. In this study, we propose to randomly allocate pregnant Indonesian women who plan to give breast feeding for no more than two months, to either care as usual or to a breast feeding empowerment program lasting to 6 months post partum. At the age of one year, all randomized offspring will undergo non-invasive echographic aortic vascular measurements and cardiovascular risk profiling. Measurements for assessing children's general health status will also be performed, including growth monitoring, repeated lung function test, and microbiomic sampling.

Official Title
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BReast Feeding Attitude and Volume Optimization (BRAVO) Trial: A Randomized Breast Feeding Optimization Experiment

Conditions
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Breast Feeding, Cardiovascular Diseases

Intervention / Treatment
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* Behavioral: Breast feeding optimization
* Behavioral: Usual care


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Plan to breast feed for ≤2 months Residing in vicinity ≤ 5 km from the hospital/agree to comply to health visit schedule Telephone communication is possible No known HIV or active tuberculosis in mother Uncomplicated pregnancy
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Breast feeding optimization<br> | Behavioral: Breast feeding optimization<br>* Breast feeding optimization program extends from late pregnancy period to 6 months after birth. Prenatal intervention consists of individual and group counseling/education; perinatal intervention consists of in-hospital lactation support; postnatal intervention consists of home visit, counseling session, reminding telephone call and bulk SMS, special counseling for working mothers, breast pump rental, occupational-related support<br>Behavioral: Usual care<br>* Usual care applied in the hospital<br>|
| Active Comparator: Usual/routine care<br> | Behavioral: Usual care<br>* Usual care applied in the hospital<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular risk | Abdominal aortic/carotid intima media thickness, distensibility, elastic modulus; pulse wave velocity, stiffness index, blood pressure; echocardiography: ejection fraction (%), fractional shortening (%), TAPSE (cm), cardiac index (L/min/m2), LV mass (grams) | 5 years | 
| Breastfeeding habits | Breastfeeding practice: Y/N, night/day, frequency (time interval between breastfeeding, e.g 2 hours) Supplementary formula: frequency/day, volume per feeding Complementary feeding: Y/N, type of foods; frequency/day Employer and employee satisfaction | 1 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child growth | Body weight, height, head circumference, abdominal circumference | 5 years | 
| Lung function | Resistance, compliance, time constant, FVC (liters), FEV1 (liters) measured by spirometry | 5 years | 
| Microbiome | Infant nasopharyngeal & oral flora, digestive tract/feces flora, maternal oropharyngeal evaluated using PCR and culture. | 1 years | 
| Development | Bayley Infant Scales, IQ | 5 years | 
| Illness | Infection/fever, allergic symptoms, wheezing, upper/lower respiratory disease, gastrointestinal symptoms | 1 year | 
| Inflammation | Serum hs-CRP, Fibrinogen | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Feeding, Cardiovascular Risk