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Effect of Breastfeeding Optimization on Early Vascular Development (BRAVO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01566812
Recruitment Status : Active, not recruiting
First Posted : March 29, 2012
Last Update Posted : March 7, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Breast Feeding Cardiovascular Diseases Behavioral: Breast feeding optimization Behavioral: Usual care

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: BReast Feeding Attitude and Volume Optimization (BRAVO) Trial: A Randomized Breast Feeding Optimization Experiment
Study Start Date : June 2012
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : February 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breastfeeding
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Cardiovascular risk [ Time Frame: 5 years ]
    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)

  2. Breastfeeding habits [ Time Frame: 1 years ]
    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


Secondary Outcome Measures :
  1. Child growth [ Time Frame: 5 years ]
    Body weight, height, head circumference, abdominal circumference

  2. Lung function [ Time Frame: 5 years ]
    Resistance, compliance, time constant, FVC (liters), FEV1 (liters) measured by spirometry

  3. Microbiome [ Time Frame: 1 years ]
    Infant nasopharyngeal & oral flora, digestive tract/feces flora, maternal oropharyngeal evaluated using PCR and culture.

  4. Development [ Time Frame: 5 years ]
    Bayley Infant Scales, IQ

  5. Illness [ Time Frame: 1 year ]
    Infection/fever, allergic symptoms, wheezing, upper/lower respiratory disease, gastrointestinal symptoms

  6. Inflammation [ Time Frame: 1 year ]
    Serum hs-CRP, Fibrinogen


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01566812


Locations
Indonesia
Budi Kemuliaan Hospital
Jakarta Pusat, DKI Jakarta, Indonesia
Sponsors and Collaborators
Indonesia University
CEEBM
Julius Center
Budi Kemuliaan Hospital
Investigators
Principal Investigator: Nikmah S Idris, MD Indonesia University
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. 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
Principal Investigator: Annemieke MV Evelein, MD Julius Center
Principal Investigator: Wahyuni Indawati, MD Indonesia University
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Nikmah Salamia Idris, Dr., Indonesia University
ClinicalTrials.gov Identifier: NCT01566812     History of Changes
Other Study ID Numbers: BRAVO_trial
First Posted: March 29, 2012    Key Record Dates
Last Update Posted: March 7, 2017
Last Verified: March 2017

Keywords provided by Nikmah Salamia Idris, Indonesia University:
Breast Feeding
Cardiovascular Risk

Additional relevant MeSH terms:
Cardiovascular Diseases