Evaluation of Preterm Infants Fed Post-Discharge Preterm Infant Formula

Abbott

Status: Completed

Conditions: Infant Development

Treatments: Other: Experimental Infant Formula

Study type: Interventional

Funder types: Industry

Identifiers

NCT03991949

AL35

Details and patient eligibility

About

This single-group study will assess growth and tolerance of infants fed a post-discharge preterm infant formula containing a prebiotic.

Enrollment: 51 patients

Sex: All

Ages: 34 to 41 weeks old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Gestational age at birth less than 37 weeks
• Birth weight less than 3200 g (approximately 7 pounds)
• Postmenstrual age is 34 0/7 through 41 0/7 weeks at enrollment
• Parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study
• The currently-fed formula is a milk-based infant formula at a caloric density of ≤ 24 Cal/fl oz.
• Singleton, twin, or triplet births only.
• Parent(s) confirm their intention not to administer solid foods or juices to their infant from enrollment through the duration of the study, unless instructed otherwise by their healthcare professional.
• Participant's parent(s) has voluntarily signed and dated an ICF, approved by an IRB/IEC and provided 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 taking medications, home remedies, herbal preparations, prebiotics or probiotics, rehydration solutions, or parenteral nutrition
• Participant is known to require elective surgery with hospitalization, other than uncomplicated outpatient surgery, during the course of the study.
• Participant is in another study that has not been approved as a concomitant study
• Participant has an allergy or intolerance to any ingredient in the study product
• Participant is currently receiving oxygen therapy
• Participant is currently receiving antibiotics
• Participant is currently receiving tube feedings

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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51 participants in 1 patient group

Experimental Infant Formula

Experimental group

Description:

Ready-to-feed, milk-based formula

Treatment:

Other: Experimental Infant Formula