Effect of Breastfeeding Optimization on Early Vascular Development (BRAVO)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Breast Feeding Cardiovascular Diseases |
Behavioral: Breast feeding optimization Behavioral: Usual care |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | BReast Feeding Attitude and Volume Optimization (BRAVO) Trial: A Randomized Breast Feeding Optimization Experiment |
- Cardiovascular risk [ Time Frame: 5 years ] [ Designated as safety issue: No ]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)
- Breastfeeding habits [ Time Frame: 1 years ] [ Designated as safety issue: No ]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
- Child growth [ Time Frame: 5 years ] [ Designated as safety issue: No ]Body weight, height, head circumference, abdominal circumference
- Lung function [ Time Frame: 5 years ] [ Designated as safety issue: No ]Resistance, compliance, time constant, FVC (liters), FEV1 (liters) measured by spirometry
- Microbiome [ Time Frame: 1 years ] [ Designated as safety issue: No ]Infant nasopharyngeal & oral flora, digestive tract/feces flora, maternal oropharyngeal evaluated using PCR and culture.
- Development [ Time Frame: 5 years ] [ Designated as safety issue: No ]Bayley Infant Scales, IQ
- Illness [ Time Frame: 1 year ] [ Designated as safety issue: No ]Infection/fever, allergic symptoms, wheezing, upper/lower respiratory disease, gastrointestinal symptoms
- Inflammation [ Time Frame: 1 year ] [ Designated as safety issue: No ]Serum hs-CRP, Fibrinogen
| Estimated Enrollment: | 1000 |
| Study Start Date: | June 2012 |
| Estimated Study Completion Date: | December 2017 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Breast feeding optimization |
Behavioral: Breast feeding optimization
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
Behavioral: Usual care
Usual care applied in the hospital
|
| Active Comparator: Usual/routine care |
Behavioral: Usual care
Usual care applied in the hospital
|
Detailed Description:
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| Contact: Nikmah S Idris, MD | 62 81310004373 | salamia.nikmah@gmail.com |
| Contact: Siti Rizny F Saldi, MSc | 62 21 3161760 | rizny.saldi@gmail.com |
| Indonesia | |
| Budi Kemuliaan Hospital | Recruiting |
| Jakarta Pusat, DKI Jakarta, Indonesia | |
| Contact: Irma Sapriani, MD 62 21 3842828 irmasapriani@yahoo.com | |
| Principal Investigator: | Nikmah S Idris, MD | University of Indonesia |
| Study Chair: | Cuno SPM Uiterwaal, Ass Prof, MD, PhD | Julius Center |
| Study Director: | Sudigdo Sastroasmoro, Prof, MD, PhD | CEEBM, University of Indonesia |
| Study Director: | Rulina Suradi, MD, Prof. | University of Indonesia |
| 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 |
| Principal Investigator: | Annemieke MV Evelein, MD | Julius Center |
| Principal Investigator: | Wahyuni Indawati, MD | University of Indonesia |
More Information
No publications provided
| Responsible Party: | Nikmah Salamia Idris, Dr., Indonesia University |
| ClinicalTrials.gov Identifier: | NCT01566812 History of Changes |
| Other Study ID Numbers: | BRAVO_trial |
| Study First Received: | March 27, 2012 |
| Last Updated: | October 5, 2012 |
| Health Authority: | Indonesia: Departement Kesehatan (Department of Health) |
Keywords provided by Indonesia University:
|
Breast Feeding Cardiovascular Risk |
Additional relevant MeSH terms:
|
Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 21, 2013