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Clinical Trials/NCT02006992
NCT02006992
Completed
Not Applicable

Growth of Infants Fed Hydrolysate Formulas

Abbott Nutrition8 sites in 1 country195 target enrollmentMarch 2000

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Growth and Tolerance
Sponsor
Abbott Nutrition
Enrollment
195
Locations
8
Primary Endpoint
Weight
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

Effects on weight and weight gain will be monitored in healthy term infants fed assigned infant formulas.

Registry
clinicaltrials.gov
Start Date
March 2000
End Date
November 2000
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Infants in good health.
  • Singleton, term birth with a gestational age of 37 to 42 weeks.
  • Birth weight of 2500 g (5 lb 8 oz) or greater.
  • Between 0 and 9 days of age at enrollment.
  • Not receiving vitamin or mineral supplements.

Exclusion Criteria

  • Maternal, fetal or perinatal medical history with potential for adverse effects on growth or development.

Outcomes

Primary Outcomes

Weight

Time Frame: Study day 1 to 112 days of age

Secondary Outcomes

  • Length(Study day 1 to 112 days of age)
  • Head Circumference(Study day 1 to 112 days of age)
  • Study Formula Intake(Enrollment to 112 days of age)
  • Incidence of Spit Up(Enrollment to 112 days of age)
  • Stool Pattern(Enrollment to 112 days of age)

Study Sites (8)

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