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Tolerance and Efficacy of Wondersun Infant Formula in Formula-fed Chinese Term Infants

Sun Yat-sen University logo

Sun Yat-sen University

Status and phase

Completed
Phase 4

Conditions

Infant Nutrition

Treatments

Other: Infant formula
Other: Breast feeding

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01157390
INF-004

Details and patient eligibility

About

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 study. A breast fed group will serve as reference. The study will be conducted in Guangzhou from 2010.1~2010.12.

Participants: 0-14 d whole formula-fed infants and whole breast-fed infants, 30 infants in each group. They are required to be healthy, term-infant, and with normal birth weight, and have no medications known to affect their growth and development.

Intervention: The formula-fed infants will be fed Wondersun formula with high proportion of palmitic acid in the sn-2 position; and breast-fed groups will be fed using breast milk for at least 3 month.

Outcome measures: Tolerance and efficacy will be assessed by body measurement, stool characteristics questionnaire, general health examination, and behavior and habit questionnaire at baseline (0-14d), 6 weeks and 12 weeks. Safety will also be evaluated.

Statistical analysis: t-test, rank test and chi-square test will be used to examine the significance of change from baseline to follow-up visit between the formula-fed and breast-fed groups for effectiveness measures

Enrollment

75 patients

Sex

All

Ages

Under 14 days old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 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 criteria

  • 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).

Trial design

Primary purpose

Supportive Care

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

75 participants in 2 patient groups

Infant formula
Experimental group
Description:
The infants will be fed with Wondersun infant formula with high proportion of palmitic acid at the sn-2 position
Treatment:
Other: Infant formula
Breast feeding
Active Comparator group
Description:
Complete breast feed within the first 3 month
Treatment:
Other: Breast feeding

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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