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The trial is taking place at:
M

Maximos OB/Gyn | League City, TX

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Infant Formula and Toddler Drink Feeding Study

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Abbott

Status

Active, not recruiting

Conditions

Growth

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

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

637 participants in 3 patient groups

Control Feeding Group
Active Comparator group
Description:
Milk based product
Treatment:
Other: Control Infant Formula
Other: Control Toddler Drink
Experimental Feeding Group
Experimental group
Description:
Milk based product with oligosaccharides
Treatment:
Other: Experimental Toddler Drink
Other: Experimental Infant Formula
Human Milk Reference Group
Other group
Description:
Human Milk
Treatment:
Other: Human Milk
Other: Human Milk Toddler Drink
Other: Human Milk Supplemental Formula

Trial contacts and locations

43

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Central trial contact

Kristen DeLuca, MS, RDN, LDN

Data sourced from clinicaltrials.gov

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