The Growth and Development of Breast and Formula Fed Term Asian Infants

Study Overview
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Brief Summary
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Prospective cohort study of breast and formula fed infants in a suburban setting in Jakarta, Indonesia

Official Title
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The Growth and Development of Breast and Formula Fed (Containing Synbiotics and LCPUFA) Term Asian Infants.

Conditions
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Growth

Intervention / Treatment
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* Other: Breastfeeding
* Other: Infant formula


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Breast-fed: 1. Mother intends to exclusively breast-feed from birth to at least 4 months; 2. A healthy term infant with gestational age fo 37-42 weeks and birth weight greater than or equal to 2.5 kg and equal or less than 4.75 kg. Formula-fed: 1. Mother is exclusively feeding infant formula milk less than or equal to 6 weeks of birth and has no prospect of breastfeeding; 2. A healthy term infant with gestational age fo 37-42 weeks and birth weight greater than or equal to 2.5 kg and equal or less than 4.75 kg; 3. Mother consents to her infant receiving trial infant formula for 12 months. Exclusion Criteria: 1. Severe congenital or metabolic disease likely to affect infant feeding or infant growth. 2. Multiple birth

Ages Eligible for Study
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Minimum Age: 2 Weeks
Maximum Age: 6 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Breast-fed infants<br>80 infants of mothers who plan to exclusively breastfeed for at least 6 months. | Other: Breastfeeding<br> <br> |
| Formula-fed infants<br>Mother is exclusively feeding infant formula milk less than or equal to 6 weeks of birth and has no prospect of breastfeeding. Mother consents to her infant receiving trial infant formula for 12 months | Other: Infant formula<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infant weight, body length head circumference | Infant weight, body length head circumference at enrolment, 2 weeks, 4 weeks and monthly thereafter until 6 months, and then at 8, 10 and 12 months. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastrointestinal tolerance | Gastrointestinal tolerance: stool frequency and consistency using Bristol Stool Chart monthly up to 6 months | 6 months | 
| Indicators or formula tolerance | Indicators or formula tolerance: crying, irritability, sleep patterns | 12 months | 
| General health | General health: any hospitalisation, doctor visits, symptoms of respiratory or gastrointestinal infection, fever, antibiotic and medication usage | 12 months | 
| Gut integrity | Gut integrity: faecal Alpha1-antitrypsin and faecal calprotectin | 3 months | 
| Gut microflora | Gut microflora: real time PCR | 3 months | 
| Developmental progress | Developmental progress: assessed by Ages and Stages | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prospective observational study, Breast feeding, Infant formula, Infant, Indonesia