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Completed

NCT Number: NCT01157390

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

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

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Key information

Conditions

Age range

Up to 14 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510630, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Infant Formula

Other

Name: Infant formula with high proportion of palmitic acid in the sn-2 position Dosage & frequency: Fed as need Duration: at least 3 months

Other names: Wondersun Brand An Li Cong Infant Formula

breast feeding

Other

Breast feeding

Other names: Not relevant

Primary outcomes

  1. Anthropometric parameters

    Time frame: 12 weeks

    body length, body weight, and head circumferences

Secondary outcomes

  1. Efficacy and safety

    Time frame: 6 weeks

    Stool characteristics General health and wellbeing Behavior and habits Adverse events Concomitant medications Covariates or potential confounders

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Collaborators

  • Enzymotec

Registry information

Official study title

Tolerance and Efficacy of Wondersun Infant Formula in Formula-fed Chinese Term Infants: an Open Label, Controlled Trial

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jul 7, 2010
Registry last updated
Jun 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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