Effect of Breastfeeding Optimization on Early Vascular Development

Cardiovascular Diseases Clinical Trial

— BRAVO  

Official title:

BReast Feeding Attitude and Volume Optimization (BRAVO) Trial: A Randomized Breast Feeding Optimization Experiment

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01566812
• Other study ID #: BRAVO_trial
• Status: Active, not recruiting
• Phase: N/A
• First received: March 27, 2012
• Last updated: March 5, 2017
• Start date: June 2012
• Est. completion date: February 2018

Study information

• Verified date: March 2017
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1000
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Feeding
• Cardiovascular Diseases

Intervention

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
• Usual care
Usual care applied in the hospital

Locations

Country	Name	City	State
Indonesia	Budi Kemuliaan Hospital	Jakarta Pusat	DKI Jakarta

Sponsors (4)

Lead Sponsor	Collaborator
Indonesia University	Budi Kemuliaan Hospital, CEEBM, Julius Center

Country where clinical trial is conducted

Indonesia, 

Outcome

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