Infant DevelopmentNCT03991949
Evaluation of Preterm Infants Fed Post-Discharge Preterm Infant Formula
A study testing Experimental Infant Formula in people with Infant Development, run by Abbott Nutrition at 7 sites in United States.
Trial summary
This single-group study will assess growth and tolerance of infants fed a post-discharge preterm infant formula containing a prebiotic. Read more about this study
- Who is it for?
- Ages 34 to 41 weeksHealthy volunteers can take part
- Conditions the study is for
- Infant Development
- What is being tested?
- Experimental Infant Formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 7 sitesUnited States
- Study dates
- 4 Oct 2019to 16 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 34 to 41 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
MetroHealth Medical Center
Cleveland, Ohio, 44109
Women's Hospital at Renaissance - Doctors Hospital at Renaissance
Edinburg, Texas, 78539
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Maximos Ob/Gyn
League City, Texas, 77573
University of Louisville Research Foundation, Inc.
Louisville, Kentucky, 40202
The Cleveland Pediatric Research Center, LLC
Middleburg Heights, Ohio, 44130
University of South Florida
Tampa, Florida, 33606
About this study
Official title: Evaluation of Preterm Infants Fed Post-Discharge Preterm Infant Formula With Prebiotic
This single-group study will assess growth and tolerance of infants fed a post-discharge preterm infant formula containing a prebiotic.
- Conditions
- Infant Development
- Being tested
- Experimental Infant Formula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental Infant FormulaOther
Formula fed Ad libitum
| Study group | Role | What they receive |
|---|---|---|
| Experimental Infant Formula | Experimental | Ready-to-feed, milk-based formula Receives: Other: Experimental Infant Formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
Change in weight-for-age z-score
Measured: SDAY 1 to SDAY 56
Secondary outcomes (4)
Stool Characteristics
Parent completed diary
Measured: Study Day (SDAY) 1 to SDAY 56
Formula Intake
Parent completed diary
Measured: SDAY 1 to SDAY 56
Length
Interval length gain per day
Measured: SDAY 1 to SDAY 56
Head Circumference
Interval HC gain per day
Measured: SDAY 1 to SDAY 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2019
- Study start4 Oct 2019
- Primary completion16 Nov 2022
- Study completion16 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant DevelopmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michelle Johnson, RDN, LD, Study chair, Abbott Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03991949
- Sponsor's protocol ID
- AL35
- Status last verified
- Dec 2022
- First submitted
- 18 Jun 2019
- Last updated
- 13 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Preterm Infants Fed Post-Discharge Preterm Infant Formula With Prebiotic
- ClinicalTrials.gov ID
- NCT03991949
- Acronym / sponsor ID
- AL35
- Conditions
- Infant Development
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- 4 Oct 2019 (actual)
- Primary completion
- 16 Nov 2022 (actual)
- Study completion
- 16 Nov 2022 (actual)
- First posted
- 19 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This single-group study will assess growth and tolerance of infants fed a post-discharge preterm infant formula containing a prebiotic.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Infant Formula | Experimental | Other: Experimental Infant FormulaReady-to-feed, milk-based formula |
Who may qualify
- Ages
- 34 to 41 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental Infant FormulaFormula fed Ad libitum | Other | Experimental Infant Formula |
Primary outcome
Weight
Time frame: SDAY 1 to SDAY 56
Change in weight-for-age z-score
4 secondary outcomes
Stool Characteristics
Time frame: Study Day (SDAY) 1 to SDAY 56
Formula Intake
Time frame: SDAY 1 to SDAY 56
Length
Time frame: SDAY 1 to SDAY 56
Head Circumference
Time frame: SDAY 1 to SDAY 56
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle Johnson, RDN, LD study chair
Abbott Nutrition
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Infant Formula in people with Infant Development, run by Abbott Nutrition at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight (time frame: SDAY 1 to SDAY 56). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2022.