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| Name | Class |
|---|---|
| CEEBM | UNKNOWN |
| Julius Center | OTHER |
| Budi Kemuliaan Hospital | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breast feeding optimization | Experimental |
| |
| Usual/routine care | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Breast feeding optimization | Behavioral | 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 |
| 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 |
| 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 |
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Inclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Nikmah S Idris, MD | Indonesia University | Principal Investigator |
| Cuno SPM Uiterwaal, Ass Prof, MD, PhD | Julius Center | Study Chair |
| Sudigdo Sastroasmoro, Prof, MD, PhD | CEEBM, University of Indonesia | Study Director |
| Rulina Suradi, MD, Prof. | Indonesia University | Study Director |
| Diederick E Grobbee, Prof, MD, PhD | Julius Center | Study Director |
| Mohammad Baharuddin, MD | Budi Kemuliaan Hospital | Study Director |
| Debby Bogaert, MD, PhD | Utrecht University | Study Director |
| Annemieke MV Evelein, MD | Julius Center | Principal Investigator |
| Wahyuni Indawati, MD | Indonesia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Budi Kemuliaan Hospital | Jakarta Pusat | DKI Jakarta | Indonesia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27250730 | Derived | Savitri AI, Idris NS, Indawati W, Saldi SR, Amelia D, Baharuddin M, Sastroasmoro S, Grobbee DE, Uiterwaal CS. BReastfeeding Attitude and Volume Optimization (BRAVO) trial: study protocol for a randomized controlled trial. Trials. 2016 Jun 2;17(1):271. doi: 10.1186/s13063-016-1397-y. |
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| ID | Term |
|---|---|
| D001942 | Breast Feeding |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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| Usual care | Behavioral | Usual care applied in the hospital |
|
| 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 |