Effect of Breastfeeding Optimization on Early Vascular Development

Not Applicable

• Conditions: Cardiovascular Diseases; Breast Feeding
• Interventions: Behavioral: Breast feeding optimization; Behavioral: Usual care

• Registration Number: NCT01566812
• Lead Sponsor: Indonesia University

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.

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 Timeline

• Study First Submitted: 2012-03-27
• Study First Submitted QC: 2012-03-27
• Study First Posted: 2012-03-29
• Study Start: 2012-06
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-05
• Last Update Posted: 2017-03-07
• Primary Completion: 2018-02
• Study Completion: 2018-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Breast feeding optimization	Breast feeding optimization	-
Breast feeding optimization	Usual care	-
Usual/routine care	Usual care	-

Primary Outcome Measures

Name	Time	Method
Cardiovascular risk	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	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

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

Trial Locations

Locations (1)

Budi Kemuliaan Hospital; 🇮🇩 Jakarta Pusat, DKI Jakarta, Indonesia