Clinical trial NCT01566812: Effect of Breastfeeding Optimization on Early Vascular Development
Official title: BReast Feeding Attitude and Volume Optimization (BRAVO) Trial: A Randomized Breast Feeding Optimization Experiment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Feeding
Cardiovascular Diseases
Keywords: Breast Feeding
Cardiovascular Risk
Lead sponsor: Indonesia University
Sponsor class: OTHER
Collaborators: name: CEEBM
name: Julius Center
name: Budi Kemuliaan Hospital
First posted: 2012-03-29
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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 criteria: 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

Primary outcomes:
measure: Cardiovascular risk
timeFrame: 5 years
measure: Breastfeeding habits
timeFrame: 1 years
Secondary outcomes:
measure: Child growth
timeFrame: 5 years
measure: Lung function
timeFrame: 5 years
measure: Microbiome
timeFrame: 1 years
measure: Development
timeFrame: 5 years
measure: Illness
timeFrame: 1 year
measure: Inflammation
timeFrame: 1 year
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Budi Kemuliaan Hospital
state: DKI Jakarta
Study officials:
affiliation: Indonesia University
name: Nikmah S Idris, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Julius Center
name: Cuno SPM Uiterwaal, Ass Prof, MD, PhD
role: STUDY_CHAIR
affiliation: CEEBM, University of Indonesia
name: Sudigdo Sastroasmoro, Prof, MD, PhD
role: STUDY_DIRECTOR
affiliation: Indonesia University
name: Rulina Suradi, MD, Prof.
role: STUDY_DIRECTOR
affiliation: Julius Center
name: Diederick E Grobbee, Prof, MD, PhD
role: STUDY_DIRECTOR
affiliation: Budi Kemuliaan Hospital
name: Mohammad Baharuddin, MD
role: STUDY_DIRECTOR
affiliation: Utrecht University
name: Debby Bogaert, MD, PhD
role: STUDY_DIRECTOR
affiliation: Julius Center
name: Annemieke MV Evelein, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Indonesia University
name: Wahyuni Indawati, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.