Growth of Infants Fed Hydrolysate Formulas

Growth and Tolerance Clinical Trial

Official title:

Growth of Infants Fed Hydrolysate Formulas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02006992
• Other study ID #: AJ57
• Status: Completed
• Phase: N/A
• First received: December 5, 2013
• Last updated: December 11, 2013
• Start date: March 2000
• Est. completion date: November 2000

Study information

• Verified date: December 2013
• Source: Abbott Nutrition
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Effects on weight and weight gain will be monitored in healthy term infants fed assigned infant formulas.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 195
• Est. completion date: November 2000
• Est. primary completion date: November 2000
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 9 Days

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Growth and Tolerance

Intervention

Other:
• RTF Infant Formula
a RTF extensively hydrolyzed infant formula
• Powder Infant Formula
a powdered extensively hydrolyzed infant formula.

Locations

Country	Name	City	State
United States	Dreyer Medical Center	Aurora	Illinois
United States	Kentucky Pediatric Research	Bardstown	Kentucky
United States	NC Children's & Young Adults' Clinical Research Foundation	Chapel Hill	North Carolina
United States	PediaResearch, LLC	Evansville	Indiana
United States	The University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	Children's Mercy Hospital	Kansas City	Missouri
United States	Arkansas Children's Hospital	Little Rock	Arkansas
United States	GrandView Medical Research	Sellersville	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Nutrition

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight		Study day 1 to 112 days of age	No
Secondary	Length		Study day 1 to 112 days of age	No
Secondary	Head Circumference		Study day 1 to 112 days of age	No
Secondary	Study Formula Intake		Enrollment to 112 days of age	No
Secondary	Incidence of Spit Up		Enrollment to 112 days of age	No
Secondary	Stool Pattern		Enrollment to 112 days of age	No