NCT01583673CompletedNot Applicable
Assessment of Growth of Infants Fed an Amino Acid Based Formula
Société des Produits Nestlé (SPN)33 sites in 1 country225 target enrollmentStarted: May 1, 2012Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 225
- Locations
- 33
- Primary Endpoint
- Weight Gain
Study Overview
Brief Summary
The primary objective of the clinical trial is to compare growth in infants (expressed as weight gain in g/day) consuming a new Amino Acid Formula to infants consuming a commercially available hypoallergenic formula over a period of 4 months.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- — to 17 Days (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy newborn infant
- •Full-term (>= 37 weeks gestation)
- •Birth weight between >= 2500 and < =4500 g
- •0-17 days of age on enrolment (day 0 is day of birth)
- •Infant's mother has elected not to breastfeed and to exclusively formula-feed infant
- •Study explained and written information provided with Caregiver demonstrating understanding of the given information
- •Informed consent signed (parent/legal representative)
Exclusion Criteria
- •Congenital illness or malformation that may affect infant feeding and/or normal growth
- •Suspected or known allergy to cow's milk protein
- •Significant pre-natal and/or post-natal disease
- •Any readmission to hospital (except for hyperbilirubinemia) prior to enrolment
- •Infant receiving prescription medication (with exception of topical antibiotics and/or treatment for thrush) or frequent use of over the counter medications except vitamin and mineral supplements
- •Infant currently participating in another conflicting clinical study
- •Infant's family who in the Investigator's assessment cannot be expected to comply with the protocol
Outcomes
Primary Outcomes
Weight Gain
Time Frame: 4 months
Mean weight gain (g/day) from enrollment to 4 months of age
Secondary Outcomes
- tolerance(4 months)
Investigators
Study Sites (33)
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