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Growth of Infants Fed an Amino Acid Infant Formula | Clinical Trials | Clareo Health

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COMPLETEDNANCT01583673

Growth of Infants Fed an Amino Acid Infant Formula

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 hypoall...

Lead sponsor: Société des Produits Nestlé (SPN)•17 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Société des Produits Nestlé (SPN)

Age

0 - 0 years

Sex

ALL

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: October 21, 2015Terms

Trial snapshot

StatusCOMPLETED

PhaseNA

Enrollment225

Start dateMay 2012

Last updatedOct 21, 2015

Condition

Locations shown

Alabama Clinical Therapeutics

Birmingham, Alabama

Alabama Clinical Therapeutics/Southlake Pediatrics

Birmingham, Alabama

Clinical Research Consortium Arizona

Phoenix, Arizona

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 21, 2015Data synced to Clareo: May 10, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions