Clinical trial NCT01583673: Growth of Infants Fed an Amino Acid Infant Formula
Official title: Assessment of Growth of Infants Fed an Amino Acid Based Formula
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Growth
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2012-04-24
Enrollment: 225
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Weight Gain
timeFrame: 4 months
Secondary outcomes:
measure: tolerance
timeFrame: 4 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Clinical Therapeutics
state: Alabama
city: Birmingham
country: United States
facility: Alabama Clinical Therapeutics/Southlake Pediatrics
state: Alabama
city: Phoenix
country: United States
facility: Clinical Research Consortium Arizona
state: Arizona
city: Park Ridge
country: United States
facility: Lutheran General Children's Hospital
state: Illinois
city: New Albany
country: United States
facility: Nassim, MCMonigle, Mescia and Associates
state: Indiana
city: Louisville
country: United States
facility: Bluegrass Clinical Research, Inc.
state: Kentucky
city: Niles
country: United States
facility: Southwestern Medical Clinic
state: Michigan
city: Stevensville
country: United States
facility: Southwestern Medical Clinic
state: Michigan
city: Lincoln
country: United States
facility: Women's Clinic of Lincoln, P.C.
state: Nebraska
city: Boone
country: United States
facility: Blue Ridge Pediatric and Adolescent Medicine, Inc.
state: North Carolina
city: Clyde
country: United States
facility: Haywood Pediatric and Adolescent Medicine Group, P.A.
state: North Carolina
city: Raleigh
country: United States
facility: Tarheel Clinical Research
state: North Carolina
city: Dayton
country: United States
facility: Ohio Pediatric Research Assn.
state: Ohio
city: Mayfield Heights
country: United States
facility: Institute of Clinical Research
state: Ohio
city: Spartanburg
country: United States
facility: Spartanburg Medical Research
state: South Carolina
city: Salt Lake City
country: United States
facility: Jean Brown Research
state: Utah
city: Spanish Fork
country: United States
facility: Clinical Research Specialists of Utah, Inc
state: Utah
Study officials:
affiliation: Le Bonheur Children's Hospital
name: Marc Corkins, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Amari S, Shahrook S, Namba F, Ota E, Mori R. Branched-chain amino acid supplementation for improving growth and development in term and preterm neonates. Cochrane Database Syst Rev. 2020 Oct 2;10(10):CD012273. doi: 10.1002/14651858.CD012273.pub2.