Status:
COMPLETED
Growth, Tolerance in Healthy Infants Fed a Partially Hydrolyzed Rice Protein
Lead Sponsor:
Sodilac
Conditions:
Growth
Allergy
Eligibility:
All Genders
Up to 1 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to assess growth and global tolerance in healthy new born infants with minor gastrointestinal troubles and/or allergic risk, fed an experimental partially hydrolyzed rice ...
Detailed Description
This objective will result in the study of non-inferiority of the experimental formula in terms of variation of weight compared with growth curves after 3 to 6 months of exclusive regime with the expe...
Eligibility Criteria
Inclusion
- Term health infants with gestational age ranging from 37 to 42 weeks
- Infants less than 1 month old
- Non breastfed children at the inclusion
- Growth parameter normal
- Apgar score \> 5 to 7 minutes
- Change in the formula because of digestive troubles (colics, gas, regurgitation) or risks of allergy
- Absence of metabolic, nervous or digestive troubles
- Absence of digestive haemorrhage, apnea or dizzy turn
Exclusion
- Partial breastfed children
- Infants presenting a cow's milk protein allergy
- Infants currently participating in another trial
- Infants presenting an organic disease involving medicinal or surgical treatment
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT00997971
Start Date
September 1 2007
End Date
August 1 2009
Last Update
October 20 2009
Active Locations (9)
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1
Aix-les-Bains, France, 73100
2
Asnières, France, 92600
3
Besançon, France, 25000
4
Boulogne-Billancourt, France, 92100