Growth and Tolerance of Infants Fed Infant Formulas

Not Applicable

Completed

• Conditions: Growth and Tolerance

• Registration Number: NCT01808105
• Lead Sponsor: Abbott Nutrition

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-03-07
• Study First Submitted QC: 2013-03-07
• Study First Posted: 2013-03-11
• Study Start: 2013-04
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-30
• Last Update Posted: 2014-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 424

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Weight	Study Day (SD) 14 - 119	Weight gain per day

Secondary Outcome Measures

Name	Time	Method
Length	Study Day (SD) 1, 14, 28, 42, 84 and 119 visits	Length and interval length gain per day
Stool Characteristics	Study Day (SD) 1-28; 3 Day Records prior to SD 42, 84 and 119 visits	Stool consistency and number per day
Feeding Tolerance	Study Day (SD) 1-28; 3 Day Records prior to SD 42, 84 and 119 visits	% of feedings with spit up associated with feeding
Head Circumference	Study Day (SD) 1, 14, 28, 42, 84 and 119 visits	Head circumference (HC) and interval HC gain per day

Trial Locations

Locations (25)

Alabama Clinical Therapeutics, LLC; 🇺🇸 Birmingham, Alabama, United States

Alabama Clinical Therapeutics; 🇺🇸 Dothan, Alabama, United States

W.O.M.B Watching Over Mothers and Babies; 🇺🇸 Tucson, Arizona, United States

Clinical Research Advantage/Colorado Springs Health Partners; 🇺🇸 Colorado Springs, Colorado, United States

Norwich Pediatric Group, PC; 🇺🇸 Norwich, Connecticut, United States

Atlantic Clinical Research Collaborative; 🇺🇸 Boynton Beach, Florida, United States

Lake Mary Pediatrics; 🇺🇸 Orange City, Florida, United States

SCORE Physician Alliance, LLC; 🇺🇸 St. Petersburg, Florida, United States

USF, College of Medicine, Dept of Pediatrics; 🇺🇸 Tampa, Florida, United States

Southeast Regional Research Group (SERRG); 🇺🇸 Columbus, Georgia, United States

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