Effect of Breastfeeding Optimization on Early Vascular Development (BRAVO)

• 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

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.

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.

• Breast Feeding
• Cardiovascular Diseases

• 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

• Experimental: Breast feeding optimization
  Interventions:

  • Behavioral: Breast feeding optimization
  • Behavioral: Usual care
• Active Comparator: Usual/routine care
  Intervention: Behavioral: Usual care

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

• CEEBM
• Julius Center
• Budi Kemuliaan Hospital