Growth and Tolerance of Infants Fed Infant Formulas

Abbott

Status: Completed

Conditions: Growth and Tolerance

Treatments: Other: Experimental Formula 1; Other: Experimental Formula 2; Other: Human Milk; Other: Control Formula

Study type: Interventional

Funder types: Industry

Identifiers

NCT01808105

AL06

Details and patient eligibility

About

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

Enrollment: 424 patients

Sex: All

Ages: Under 5 days old

Volunteers: Accepts Healthy Volunteers

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

Trial design

424 participants in 4 patient groups

Human Milk

Other group

Description:

Reference group, breast feeding ad libitum

Treatment:

Other: Human Milk

Control Formula

Active Comparator group

Description:

Ready to feed infant formula, feed ad libitum

Treatment:

Other: Control Formula

Experimental Formula 1

Experimental group

Description:

Ready to feed infant formula with human milk oligosaccharides, feed ad libitum

Treatment:

Other: Experimental Formula 1

Experimental Formula 2

Experimental group

Description:

Ready to feed infant formula with human milk oligosaccharides, feed ad libitum

Treatment:

Other: Experimental Formula 2