Infant Formula and Toddler Drink Feeding Intervention

Abbott

Status: Terminated

Conditions: Respiratory Infections in Children

Treatments: Other: Experimental Toddler Drink; Other: Experimental Infant Formula; Other: Toddler Drink for HM group; Other: Control Toddler Drink; Other: Supplemental Formula for HM Group; Other: Control Infant Formula

Study type: Interventional

Funder types: Industry

Identifiers

NCT04495738

AL38

Details and patient eligibility

About

The purpose of this randomized, multi-center, controlled, double-blind, parallel study is to evaluate the health and developmental outcomes of children fed a new infant formula and toddler drink through 24 months of age.

Enrollment: 168 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
• Participant's birth weight was ≥ 2490 g (~5 lbs. 8 oz.)
• If parent(s) elect to formula feed the participant they confirm their intention to feed their participant the study product as the sole source of feeding until 4 months of age, and as the sole milk beverage during the first 12 months of life
• If parent(s) elect to formula feed the participant, they confirm their intention to feed the participant the assigned toddler drink from 12 months of life to 24 months of life as the primary milk beverage
• If parent(s) elect to feed the participant mother's human milk, they confirm that their infant was exclusively fed mother's human milk since birth and confirm their intention to continue exclusively feeding human milk as the sole source of feeding through 4 months of age
• If parent(s) of human milk fed participant elect to supplement or wean after 4 months to 24 months of age, they confirm their intention to use the supplemental/weaning formula or toddler drink as the primary milk beverage
• Parent(s) of formula-fed participant confirm their intention not to administer vitamin or mineral supplements, from enrollment through the duration of the study
• Parent(s) confirm their intention not to administer solid foods or juices to the participant from enrollment through 6 months of age
• 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.

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
• Participant is taking and plans to continue medications (including over the counter (OTC), home remedies, 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
• Participant has been treated with antibiotics prior to enrollment

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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168 participants in 3 patient groups

Control Feeding Group

Active Comparator group

Description:

Ready to feed milk-based product

Treatment:

Other: Control Toddler Drink

Other: Control Infant Formula

Experimental Feeding Group

Experimental group

Description:

Ready to feed milk-based product with oligosaccharides

Treatment:

Other: Experimental Toddler Drink

Other: Experimental Infant Formula

Human Milk (HM) Reference Group

Other group

Description:

HM from infant's own mother and as needed supplemental infant formula and toddler milk-based product

Treatment:

Other: Toddler Drink for HM group

Other: Supplemental Formula for HM Group