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Clinical Trials/DRKS00016462
DRKS00016462
Completed
未知

Growth and Tolerance of Healthy Term Infants Fed Infant Formula With 100% Whey Protein Hydrolysate or Intact Milk Proteins (Penguin Project)

Fonterra Co-operative Group Limited0 sites251 target enrollmentJanuary 10, 2019
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Conditionsgrowth

Overview

Phase
未知
Intervention
Not specified
Conditions
growth
Sponsor
Fonterra Co-operative Group Limited
Enrollment
251
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 10, 2019
End Date
January 29, 2021
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •singleton full term birth
  • •birth weight 2500 to 4500g
  • •Apgar (any) \= 7
  • •Age 0 to 28 days
  • •exclusively breast\-fed (breastfed reference arm) or formula\-fed (formula\-fed arms) at enrolment and for at least 90 days thereafter
  • •informed consent from parents/legal guardians

Exclusion Criteria

  • •adverse maternal, foetal or Infant medical history with effects on growth or feeding tolerance
  • •maternal gestational diabetes
  • •allergy to cow´s milk proteins or increased risk of allergy
  • •rehospitalisation within 5 days of birth
  • •use of medication that affects gastrointestinal tolerance (incl. antibiotic therapy)
  • •participation in another clinical trial
  • •intention to use mixed feeding
  • •investigators uncertainty about the willingness or ability of the parents to comply with the protocol requirements

Outcomes

Primary Outcomes

Not specified

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