Growth and Tolerance of Healthy Term Infants to a New Infant Formula

Healthy Term Infants Clinical Trial

Official title:

Growth and Tolerance of Healthy Term Infants to a New Infant Formula

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01137877
• Other study ID #: AK66
• Status: Terminated
• Phase: Phase 3
• First received: June 3, 2010
• Last updated: November 24, 2010
• Start date: May 2010
• Est. completion date: October 2010

Study information

• Verified date: November 2010
• Source: Abbott Nutrition
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to evaluate the effect of two experimental milk-based infant formulas on the growth and gastrointestinal (GI) tolerance of term infants.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 399
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 11 Days

Eligibility

Inclusion Criteria:

• in good health

• singleton full term birth

• Birth weight > 2490 g.

• Infant is between 0 and 11 days of age

• Infants using medications , home remedies , herbal preparations, prebiotics, probiotics or rehydration fluids that might affect GI tolerance

• If formula-fed, parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study

• If human milk-fed, parent(s) confirm their intention to feed their infant human milk as the sole source of nutrition

• not consuming vitamin or mineral supplements, solid foods or juices through the duration of the study

Exclusion Criteria:

adverse maternal, fetal or infant medical history with potential for effects on tolerance, growth, and/or development.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Term Infants

Intervention

Other:
• Milk based infant formula powder
milk based infant formula ad lib
• Investigational Infant Formula #1
Milk based infant formula ad lib
• Investigational Infant Formula #2
Milk based infant formula powder ad lib
• Human Milk
Human milk ad lib

Locations

Country	Name	City	State
United States	Cary Pediatric Center	Cary	North Carolina
United States	Wayzata Children's Clinic Ridgeview Research	Chaska	Minnesota
United States	Dayton Clinical Research	Dayton	Ohio
United States	New England Center for Clinical Research, Inc	Fall River	Massachusetts
United States	Ohio Pediatric Research Association, Inc	Huber Heights	Ohio
United States	Northpoint Pediatrics	Indianapolis	Indiana
United States	Clinical Research Center of Nevada	Las Vegas	Nevada
United States	Midwest Children's Health Research Institute, LLC	Lincoln	Nebraska
United States	Arkansas Children's Hospital Research	Little Rock	Arkansas
United States	DCOL Center for Clinical Research	Longview	Texas
United States	University of Louisville Department of Pediatrics	Louisville	Kentucky
United States	Facey Medical Foundation	Mission Hills	California
United States	Norwich Pediatric Group	Norwich	Connecticut
United States	Parma Pediatrics	Parma	Ohio
United States	All Women's Healthcare of West Broward, Inc	Plantation	Florida
United States	Sanford Clinic Family Medicine 34th and Kiwanis	Sioux Falls	South Dakota
United States	Rockwood Clinic North Pediatrics	Spokane	Washington
United States	SCORE Physician Alliance LLC	St. Petersburg	Florida
United States	USF College of Medicine, USF Health, Department of Pediatrics	Tampa	Florida
United States	Comprehensive Pediatrics, Inc	Westlake	Ohio

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 gain		14 to 119 days of age	No
Secondary	GI tolerance		14 to 119 days of age	No
Secondary	anthropometrics		14 to 119 days of age	No