Effect of Breastfeeding Optimization on Early Vascular Development

Overview

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.

Full Title of Study: “BReast Feeding Attitude and Volume Optimization (BRAVO) Trial: A Randomized Breast Feeding Optimization Experiment”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: February 2018

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.

Interventions

  • 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

Arms, Groups and Cohorts

  • Experimental: Breast feeding optimization
  • Active Comparator: Usual/routine care

Clinical Trial Outcome Measures

Primary Measures

  • 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)
  • 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 Measures

  • Child growth
    • Time Frame: 5 years
    • Body weight, height, head circumference, abdominal circumference
  • Lung function
    • Time Frame: 5 years
    • Resistance, compliance, time constant, FVC (liters), FEV1 (liters) measured by spirometry
  • Microbiome
    • Time Frame: 1 years
    • Infant nasopharyngeal & oral flora, digestive tract/feces flora, maternal oropharyngeal evaluated using PCR and culture.
  • Development
    • Time Frame: 5 years
    • Bayley Infant Scales, IQ
  • Illness
    • Time Frame: 1 year
    • Infection/fever, allergic symptoms, wheezing, upper/lower respiratory disease, gastrointestinal symptoms
  • Inflammation
    • Time Frame: 1 year
    • Serum hs-CRP, Fibrinogen

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Indonesia University
  • Collaborator
    • CEEBM
  • Provider of Information About this Clinical Study
    • Principal Investigator: Nikmah Salamia Idris, Dr. – Indonesia University
  • Overall Official(s)
    • Nikmah S Idris, MD, Principal Investigator, Indonesia University
    • Cuno SPM Uiterwaal, Ass Prof, MD, PhD, Study Chair, Julius Center
    • Sudigdo Sastroasmoro, Prof, MD, PhD, Study Director, CEEBM, University of Indonesia
    • Rulina Suradi, MD, Prof., Study Director, Indonesia University
    • Diederick E Grobbee, Prof, MD, PhD, Study Director, Julius Center
    • Mohammad Baharuddin, MD, Study Director, Budi Kemuliaan Hospital
    • Debby Bogaert, MD, PhD, Study Director, Utrecht University
    • Annemieke MV Evelein, MD, Principal Investigator, Julius Center
    • Wahyuni Indawati, MD, Principal Investigator, Indonesia University

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