Status:
COMPLETED
Tolerance and Efficacy of Wondersun Infant Formula in Formula-fed Chinese Term Infants
Lead Sponsor:
Sun Yat-sen University
Collaborating Sponsors:
Enzymotec
Conditions:
Infant Nutrition
Eligibility:
All Genders
Up to 14 years
Phase:
PHASE4
Brief Summary
Objective: To demonstrate the well-being of Chinese term infants fed with Wondersun formula with high proportion of palmitic acid in the sn-2 position. Design \& setting: A single-center, open label ...
Eligibility Criteria
Inclusion
- Parental/legal guardian written informed consent.
- The mother had unequivocally decided not to breast-feed (for formula fed infants) or to breastfeed (for human milk fed infants).
- Term infant of Chinese origin born at 37-42 gestation weeks as determined by menstrual history and corroborated by prenatal Unltra-Sound (US) and/or physical examination.
- Birth weight appropriate for gestational age (AGA), 2500-4000g (between 10th\~ 90th percentile of body weight at same gestation age).
- The infant is apparent healthy at birth and entry to study.
- Apgar after 5 minutes \>7.
- Enrolled within their first 14 days after birth.
- The infant is a product of normal pregnancy and delivery including C-section.
- Patental ability to attend visits, interviews and willing to fill questionnaires.
Exclusion
- Mother health condition: (psychological of physical) or socioeconomic problems that may interfere with the mother's ability to take care of her infant.
- The infant suffers from a major congenital abnormality or chromosomal disorder with a clinical significance that can be detected at birth.
- The infant suffers/ed from a disease requiring mechanical ventilation or medication treatment at the first week after birth.
- The infant suffers from any suspected or known metabolic or physical limitations interfering with feeding or normal metabolism (require a special formula).
- The infant is a carry of HBV (HBsAb positive).
Key Trial Info
Start Date :
February 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT01157390
Start Date
February 1 2010
End Date
June 1 2011
Last Update
June 8 2017
Active Locations (1)
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1
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510630