Growth and Tolerance of Infants Fed Infant Formulas

Growth and Tolerance Clinical Trial

Official title:

Growth and Tolerance of Young Infants Fed Infant Formulas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01808105
• Other study ID #: AL06
• Status: Completed
• Phase: N/A
• First received: March 7, 2013
• Last updated: May 30, 2014
• Start date: April 2013
• Est. completion date: February 2014

Study information

• Verified date: May 2014
• Source: Abbott Nutrition
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

To evaluate growth and tolerance of healthy term infants fed experimental infant formulas, a commercial infant formula and human breast milk.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 424
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 5 Days

Eligibility

Inclusion Criteria:

• Singleton from full term birth with a gestational age 37-42 weeks

• Birth weight > 2490 g (~5 lbs 8 oz)

• Between 0 and 5 days of age

• Smoke-free home (no smoking in the house dwelling), and mothers in the breast-fed group are prohibited from smoking during the study period

• Parent(s) of formula-fed infants have elected not to breastfeed and confirm that their infant has been exclusively formula-fed since birth and confirm their intention is to exclusively feed their infant study infant formula for the duration of the study,

• Parent(s) of human milk-fed infants have elected to breastfeed and confirm that their infant has been exclusively human milk-fed (not donor milk) since birth and confirm their intention is to continue to exclusively feed human milk with vitamin/mineral supplementation for the duration of the study

• No administration vitamin or mineral supplements (excluding vitamin or mineral supplements containing vitamin D, if recommended by a healthcare professional), solid foods or juices to infants from enrollment through the duration of the study, unless instructed otherwise by their healthcare professional

Exclusion Criteria:

• Adverse maternal, fetal or infant medical history that has potential effects on tolerance, growth, and/or development

• Infants using medications, home remedies, herbal preparations, probiotics or rehydration fluids that might affect gastrointestinal (GI) tolerance may not be enrolled

• Treatment with antibiotics

• Mother intends to use a combination of breast and formula feeding

Study Design

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

Related Conditions & MeSH terms

• Growth and Tolerance

Intervention

Other:
• Control Formula
Feeding ad libitum
• Experimental Formula 1
Feeding ad libitum
• Experimental Formula 2
Feeding ad libitum
• Human Milk
Feeding ad libitum

Locations

Country	Name	City	State
Puerto Rico	Clinical Research Puerto Rico	Guayama
Puerto Rico	Ponce School of Medicine/ CAIMED Center	Ponce
United States	Alabama Clinical Therapeutics, LLC	Birmingham	Alabama
United States	Atlantic Clinical Research Collaborative	Boynton Beach	Florida
United States	MetroHealth Medical Center	Cleveland	Ohio
United States	Clinical Research Advantage/Colorado Springs Health Partners	Colorado Springs	Colorado
United States	Southeast Regional Research Group (SERRG)	Columbus	Georgia
United States	Dayton Clinical Research	Dayton	Ohio
United States	Ohio Pediatric Research Association, Inc	Dayton	Ohio
United States	Alabama Clinical Therapeutics	Dothan	Alabama
United States	Clinical Trials of America	Eugene	Oregon
United States	PediaResearch, LLC	Evansville	Indiana
United States	Northpoint Pediatrics, LLC	Indianapolis	Indiana
United States	Lafayette Clinical Research	Lafayette	Indiana
United States	Tanner Memorial Clinic	Layton	Utah
United States	Women's Clinic of Lincoln, PC	Lincoln	Nebraska
United States	Institute of Clinical Research	Mayfield Heights	Ohio
United States	Norwich Pediatric Group, PC	Norwich	Connecticut
United States	Lake Mary Pediatrics	Orange City	Florida
United States	Red Lion Pediatrics	Philadelphia	Pennsylvania
United States	Sanford Research	Sioux Falls	South Dakota
United States	Rockwood Clinic, PS	Spokane	Washington
United States	SCORE Physician Alliance, LLC	St. Petersburg	Florida
United States	USF, College of Medicine, Dept of Pediatrics	Tampa	Florida
United States	W.O.M.B Watching Over Mothers and Babies	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Nutrition

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Study Formula Intake	Average volume of study formula intake and average number of study formula feedings per day	Study Day (SD) 1-28; 3 Day Records prior to SD 42, 84 and 119 visits	No
Other	Oligosaccharides	Infant urine sample	Study Day (SD) 42 and 119 visits	No
Primary	Weight	Weight gain per day	Study Day (SD) 14 - 119	No
Secondary	Stool Characteristics	Stool consistency and number per day	Study Day (SD) 1-28; 3 Day Records prior to SD 42, 84 and 119 visits	No
Secondary	Feeding Tolerance	% of feedings with spit up associated with feeding	Study Day (SD) 1-28; 3 Day Records prior to SD 42, 84 and 119 visits	Yes
Secondary	Length	Length and interval length gain per day	Study Day (SD) 1, 14, 28, 42, 84 and 119 visits	No
Secondary	Head Circumference	Head circumference (HC) and interval HC gain per day	Study Day (SD) 1, 14, 28, 42, 84 and 119 visits	No