Clinical trial NCT01808105: Growth and Tolerance of Infants Fed Infant Formulas
Official title: Growth and Tolerance of Young Infants Fed Infant Formulas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Growth and Tolerance
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2013-03-11
Enrollment: 424
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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


Eligibility criteria: 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

Primary outcomes:
measure: Weight
timeFrame: Study Day (SD) 14 - 119
Secondary outcomes:
measure: Stool Characteristics
timeFrame: Study Day (SD) 1-28; 3 Day Records prior to SD 42, 84 and 119 visits
measure: Feeding Tolerance
timeFrame: Study Day (SD) 1-28; 3 Day Records prior to SD 42, 84 and 119 visits
measure: Length
timeFrame: Study Day (SD) 1, 14, 28, 42, 84 and 119 visits
measure: Head Circumference
timeFrame: Study Day (SD) 1, 14, 28, 42, 84 and 119 visits
Other outcomes:
measure: Study Formula Intake
timeFrame: Study Day (SD) 1-28; 3 Day Records prior to SD 42, 84 and 119 visits
measure: Oligosaccharides
timeFrame: Study Day (SD) 42 and 119 visits
Locations:
city: Birmingham
country: United States
facility: Alabama Clinical Therapeutics, LLC
state: Alabama
city: Dothan
country: United States
facility: Alabama Clinical Therapeutics
state: Alabama
city: Tucson
country: United States
facility: W.O.M.B Watching Over Mothers and Babies
state: Arizona
city: Colorado Springs
country: United States
facility: Clinical Research Advantage/Colorado Springs Health Partners
state: Colorado
city: Norwich
country: United States
facility: Norwich Pediatric Group, PC
state: Connecticut
city: Boynton Beach
country: United States
facility: Atlantic Clinical Research Collaborative
state: Florida
city: Orange City
country: United States
facility: Lake Mary Pediatrics
state: Florida
city: St. Petersburg
country: United States
facility: SCORE Physician Alliance, LLC
state: Florida
city: Tampa
country: United States
facility: USF, College of Medicine, Dept of Pediatrics
state: Florida
city: Columbus
country: United States
facility: Southeast Regional Research Group (SERRG)
state: Georgia
city: Evansville
country: United States
facility: PediaResearch, LLC
state: Indiana
city: Indianapolis
country: United States
facility: Northpoint Pediatrics, LLC
state: Indiana
city: Lafayette
country: United States
facility: Lafayette Clinical Research
state: Indiana
city: Lincoln
country: United States
facility: Women's Clinic of Lincoln, PC
state: Nebraska
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
city: Dayton
country: United States
facility: Dayton Clinical Research
state: Ohio
city: Dayton
country: United States
facility: Ohio Pediatric Research Association, Inc
state: Ohio
city: Mayfield Heights
country: United States
facility: Institute of Clinical Research
state: Ohio
city: Eugene
country: United States
facility: Clinical Trials of America
state: Oregon
city: Philadelphia
country: United States
facility: Red Lion Pediatrics
state: Pennsylvania
city: Sioux Falls
country: United States
facility: Sanford Research
state: South Dakota
city: Layton
country: United States
facility: Tanner Memorial Clinic
state: Utah
city: Spokane
country: United States
facility: Rockwood Clinic, PS
state: Washington
city: Guayama
country: Puerto Rico
facility: Clinical Research Puerto Rico
city: Ponce
country: Puerto Rico
facility: Ponce School of Medicine/ CAIMED Center
Study officials:
affiliation: Abbott Nutrition
name: Jennifer Williams, MPH
role: STUDY_CHAIR
References:
citation: Goehring KC, Marriage BJ, Oliver JS, Wilder JA, Barrett EG, Buck RH. Similar to Those Who Are Breastfed, Infants Fed a Formula Containing 2'-Fucosyllactose Have Lower Inflammatory Cytokines in a Randomized Controlled Trial. J Nutr. 2016 Dec;146(12):2559-2566. doi: 10.3945/jn.116.236919. Epub 2016 Oct 26.