NCT03991949CompletedNot Applicable
Evaluation of Preterm Infants Fed Post-Discharge Preterm Infant Formula With Prebiotic
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Abbott Nutrition
- Enrollment
- 51
- Locations
- 14
- Primary Endpoint
- Weight
Study Overview
Brief Summary
This single-group study will assess growth and tolerance of infants fed a post-discharge preterm infant formula containing a prebiotic.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 34 Weeks to 41 Weeks (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Weight
Time Frame: SDAY 1 to SDAY 56
Change in weight-for-age z-score
Secondary Outcomes
- Formula Intake(SDAY 1 to SDAY 56)
- Length(SDAY 1 to SDAY 56)
- Head Circumference(SDAY 1 to SDAY 56)
- Stool Characteristics(Study Day (SDAY) 1 to SDAY 56)
Investigators
Study Sites (14)
Loading locations...
Similar Trials
Terminated
Phase 4
Comparison of Post-Discharge Growth of Premature Infants Using Two Different FormulasPremature Birth of NewbornNCT01759134Shaare Zedek Medical Center30
Not yet recruiting
Not Applicable
Preterm Infants Fed a Human Milk FortifierGrowthNCT05551975Abbott Nutrition321
Completed
Phase 2
Evaluation of a Standard Preterm Infant Formula Fed to Preterm Infants in the HospitalPre-term InfantsNCT01766011Abbott Nutrition28
Completed
Not Applicable
Targeted Nutrition for Moderate to Late Preterm InfantsBreastmilk CollectionPostnatal Growth RestrictionPremature BirthNCT05515614Loma Linda University34
Completed
Not Applicable
Post-discharge growth, body composition and neurodevelopment outcome of very preterm infants in relation to two formulas with different composition in terms of energy and protein contentPre-term infant post-discharge nutrition and body compositionPregnancy and ChildbirthDisorders related to short gestation and low birth weight, not elsewhere classifiedISRCTN30189842Fondazione IRCCS Ospedale Maggiore Policlinico Mangiagalli Regina Elena (Italy)184