Infant Formula and Toddler Drink Feeding Study

Abbott

Status: Active, not recruiting

Conditions: Growth

Treatments: Other: Human Milk; Other: Human Milk Toddler Drink; Other: Human Milk Supplemental Formula; Other: Control Toddler Drink; Other: Control Infant Formula; Other: Experimental Toddler Drink; Other: Experimental Infant Formula

Study type: Interventional

Funder types: Industry

Identifiers

NCT04957992

AL51

Details and patient eligibility

About

The purpose of this study is to evaluate the growth and development outcomes of infants fed a new infant formula and toddler drink through 24 months of age.

Enrollment: 637 patients

Sex: All

Ages: Under 14 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Participant is judged to be in good health as determined from participant's medical history
• Participant is a singleton from a full-term birth with a gestational age of 37 - 42 weeks by parent report
• Participant's birth weight was ≥ 2490 g (~5 lbs. 8 oz.)
• Parent(s) confirm their intention to feed their infant the study product as the sole source of feeding from Study Visit 1 to 6 months of age, and as the sole milk beverage during the first 12 months of life
• Parent(s) confirm their intention to feed the infant the assigned toddler drink from 12 months of life to 24 months of life as the primary milk beverage
• Parent(s) confirm their intention not to administer vitamin or mineral supplements,(except for vitamin D supplements if instructed by their healthcare professional) from enrollment through the duration of the study
• Parent(s) confirm their intention not to administer solid foods or juices to the infant from enrollment through 6 months of age unless recommended by the participant's HCP
• Participant's parent(s) has voluntarily signed and dated an informed consent form (ICF), approved by an Institutional Review Board/Independent Ethics Committee (IRB/IEC) and provided Health Insurance Portability and Accountability Act (HIPAA) (or other applicable privacy regulation) authorization prior to any participation in the study
• If parent(s) elect to feed the participant human milk, they confirm that their infant was fed human milk since birth and confirm their intention to exclusively feed human milk as the sole source of feeding through 6 months of age.
• If parent(s) of human milk fed participant elect to supplement or wean, they confirm their intention to use the experimental supplemental/weaning formula and experimental toddler drink as the primary milk beverage.

Exclusion criteria

• An adverse maternal, fetal or participant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development
• Awareness of a positive drug screen (including but not limited to cocaine, heroin, or methamphetamine) in the mother or participant
• Suspected maternal substance abuse including alcohol
• Participant is taking and plans to continue medications (including over the counter (OTC), such as Mylicon® for gas), home remedies (such as juice for constipation), herbal preparations, prebiotics or probiotics, or rehydration fluids that might affect GI tolerance
• Participant is in another study that has not been approved as a concomitant study by AN
• Participant has been treated with antibiotics (except for topical antibiotics, eye drops) prior to enrollment
• Participant has been treated with other medications (besides antibiotics) that in the opinion of the PI may affect growth, GI tolerance and/or development, prior to enrollment

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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637 participants in 3 patient groups

Control Feeding Group

Active Comparator group

Description:

Milk based product

Treatment:

Other: Control Toddler Drink

Other: Control Infant Formula

Experimental Feeding Group

Experimental group

Description:

Milk based product with oligosaccharides

Treatment:

Other: Experimental Infant Formula

Other: Experimental Toddler Drink

Human Milk Reference Group

Other group

Description:

Human Milk

Treatment:

Other: Human Milk Toddler Drink

Other: Human Milk

Other: Human Milk Supplemental Formula