Effect of Breastfeeding Optimization on Early Vascular Development (BRAVO)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Indonesia University
Sponsor:
Collaborators:
CEEBM
Julius Center
Budi Kemuliaan Hospital
Information provided by (Responsible Party):
Nikmah Salamia Idris, Indonesia University
ClinicalTrials.gov Identifier:
NCT01566812
First received: March 27, 2012
Last updated: October 6, 2014
Last verified: October 2012
  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

Resource links provided by NLM:


Further study details as provided by Indonesia University:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 2016 (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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01566812

Contacts
Contact: Nikmah S Idris, MD 62 81310004373 salamia.nikmah@gmail.com
Contact: Siti Rizny F Saldi, MSc 62 21 3161760 rizny.saldi@gmail.com

Locations
Indonesia
Budi Kemuliaan Hospital Recruiting
Jakarta Pusat, DKI Jakarta, Indonesia
Contact: Irma Sapriani, MD    62 21 3842828    irmasapriani@yahoo.com   
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

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 6, 2014
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 October 28, 2014