CTRI/2010/091/001111
Completed
Phase 3
Growth of infants who are supplementary fed / mixed fed with probiotics-containing formula in India
estec Ltd0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- estec Ltd
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Healthy newborn infant who required supplemented/mixed feeding due to partial lactation failure or informed choice
- •2\. Age at point of enrollment: less than 3 months of age
- •3\. Gestational age \&\#8805;37 weeks and \&\#8804;42 weeks
- •4\. Birth weight is \&\#8805; 2?500 g and \&\#8804; 4?500 g
- •5\. Singleton birth
- •6\. Mothers' education: minimum of 7 years of schooling
- •7\. Parent/carer is expected to remain in the investigational site geographical area for the next 12 months
- •8\. Having obtained the legal representative?s informed consent
Exclusion Criteria
- •1\.Currently participating in another clinical trial
- •2\.Infant from mother with diabetes during pregnancy
- •3\.Infant from HIV positive mother
- •4\.Congenital illness or malformation that may affect normal growth
- •5\.Significant pre\-natal and/or post\-natal disease
- •6\. Re\-hospitalisation before inclusion in the study for more than 2 days for any reason except jaundice
- •7\. Subject whose parent/carer cannot be expected to understand and to comply with feeding plan or instructions
Outcomes
Primary Outcomes
Not specified
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