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Growth of Infants Fed Hydrolysate Formulas

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott Nutrition
ClinicalTrials.gov Identifier:
NCT02006992
First received: December 5, 2013
Last updated: December 11, 2013
Last verified: December 2013
  Purpose
Effects on weight and weight gain will be monitored in healthy term infants fed assigned infant formulas.

Condition Intervention
Growth and Tolerance
Other: RTF Infant Formula
Other: Powder Infant Formula

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: Growth of Infants Fed Hydrolysate Formulas

Resource links provided by NLM:


Further study details as provided by Abbott Nutrition:

Primary Outcome Measures:
  • Weight [ Time Frame: Study day 1 to 112 days of age ]

Secondary Outcome Measures:
  • Length [ Time Frame: Study day 1 to 112 days of age ]
  • Head Circumference [ Time Frame: Study day 1 to 112 days of age ]
  • Study Formula Intake [ Time Frame: Enrollment to 112 days of age ]
  • Incidence of Spit Up [ Time Frame: Enrollment to 112 days of age ]
  • Stool Pattern [ Time Frame: Enrollment to 112 days of age ]

Enrollment: 195
Study Start Date: March 2000
Study Completion Date: November 2000
Primary Completion Date: November 2000 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: RTF Infant Formula 1
a ready to feed (RTF) extensively hydrolyzed infant formula fed ad lib.
Other: RTF Infant Formula
a RTF extensively hydrolyzed infant formula
Experimental: Powder Infant Formula 2
a powdered extensively hydrolyzed infant formula fed ad lib.
Other: Powder Infant Formula
a powdered extensively hydrolyzed infant formula.

  Eligibility

Ages Eligible for Study:   up to 9 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Infants in good health.
  • Singleton, term birth with a gestational age of 37 to 42 weeks.
  • Birth weight of 2500 g (5 lb 8 oz) or greater.
  • Between 0 and 9 days of age at enrollment.
  • Not receiving vitamin or mineral supplements.

Exclusion Criteria:

- Maternal, fetal or perinatal medical history with potential for adverse effects on growth or development.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02006992

Locations
United States, Arkansas
Arkansas Children's Hospital
Little Rock, Arkansas, United States
United States, Illinois
Dreyer Medical Center
Aurora, Illinois, United States
United States, Indiana
PediaResearch, LLC
Evansville, Indiana, United States
United States, Iowa
The University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
United States, Kentucky
Kentucky Pediatric Research
Bardstown, Kentucky, United States
United States, Missouri
Children's Mercy Hospital
Kansas City, Missouri, United States
United States, North Carolina
NC Children's & Young Adults' Clinical Research Foundation
Chapel Hill, North Carolina, United States
United States, Pennsylvania
GrandView Medical Research
Sellersville, Pennsylvania, United States
Sponsors and Collaborators
Abbott Nutrition
Investigators
Study Chair: Marlene Borschel, RD, PhD Abbott Nutrition
  More Information

Responsible Party: Abbott Nutrition
ClinicalTrials.gov Identifier: NCT02006992     History of Changes
Other Study ID Numbers: AJ57
Study First Received: December 5, 2013
Last Updated: December 11, 2013

ClinicalTrials.gov processed this record on April 21, 2017