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Clinical Trials/NCT01137877
NCT01137877
Terminated
Phase 3

Growth and Tolerance of Healthy Term Infants to a New Infant Formula

Abbott Nutrition20 sites in 1 country399 target enrollmentMay 2010
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ConditionsHealthy Term Infants

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Healthy Term Infants
Sponsor
Abbott Nutrition
Enrollment
399
Locations
20
Primary Endpoint
weight gain
Status
Terminated
Last Updated
15 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

The objective of this study is to evaluate the effect of two experimental milk-based infant formulas on the growth and gastrointestinal (GI) tolerance of term infants.

Registry
clinicaltrials.gov
Start Date
May 2010
End Date
October 2010
Last Updated
15 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •in good health
  • •singleton full term birth
  • •Birth weight \> 2490 g.
  • •Infant is between 0 and 11 days of age
  • •Infants using medications , home remedies , herbal preparations, prebiotics, probiotics or rehydration fluids that might affect GI tolerance
  • •If formula-fed, parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study
  • •If human milk-fed, parent(s) confirm their intention to feed their infant human milk as the sole source of nutrition
  • •not consuming vitamin or mineral supplements, solid foods or juices through the duration of the study

Exclusion Criteria

  • •adverse maternal, fetal or infant medical history with potential for effects on tolerance, growth, and/or development.

Outcomes

Primary Outcomes

weight gain

Time Frame: 14 to 119 days of age

Secondary Outcomes

  • GI tolerance(14 to 119 days of age)
  • anthropometrics(14 to 119 days of age)

Study Sites (20)

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