Clinical trial NCT03991949: Evaluation of Preterm Infants Fed Post-Discharge Preterm Infant Formula
Official title: Evaluation of Preterm Infants Fed Post-Discharge Preterm Infant Formula With Prebiotic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant Development
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2019-06-19
Enrollment: 51
Sex: ALL
Minimum age (years): 34
Maximum age (years): 41
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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


Eligibility criteria: 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

Primary outcomes:
measure: Weight
timeFrame: SDAY 1 to SDAY 56
Secondary outcomes:
measure: Stool Characteristics
timeFrame: Study Day (SDAY) 1 to SDAY 56
measure: Formula Intake
timeFrame: SDAY 1 to SDAY 56
measure: Length
timeFrame: SDAY 1 to SDAY 56
measure: Head Circumference
timeFrame: SDAY 1 to SDAY 56
Other outcomes:
Locations:
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Louisville
country: United States
facility: University of Louisville Research Foundation, Inc.
state: Kentucky
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
city: Middleburg Heights
country: United States
facility: The Cleveland Pediatric Research Center, LLC
state: Ohio
city: Edinburg
country: United States
facility: Women's Hospital at Renaissance - Doctors Hospital at Renaissance
state: Texas
city: League City
country: United States
facility: Maximos Ob/Gyn
state: Texas
Study officials:
affiliation: Abbott Nutrition
name: Michelle Johnson, RDN, LD
role: STUDY_CHAIR
References: